BP CRUSH: A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure

• Sponsor: Daiichi Sankyo, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00791258
• Collaborator: Integrium (Industry)
• Enrollment: 999
• Locations: 72
• Arm: 1
• Duration (Months): 10
• Patients Per Site: 13.9
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood pressure reduction using one anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to lower blood pressure in the same patient population. All three medications being tested have been approved by the FDA for the treatment of high blood pressure, but only amlodipine and olmesartan are currently approved for use in combination form.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: amlodipine and olmesartan medoxomil tablets; Drug: hydrochlorothiazide tablets	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 999 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Open-Label, Titration Study to Evaluate the Efficacy and Safety Safety of AZOR in Multiple Subgroups of Hypertensive Subjects Who Are Non-Responders to Anti-Hypertensive Monotherapy
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Azor tablets and hydrochlorothiazide tablets (if necessary) will be administered for up to 20 weeks	Drug: amlodipine and olmesartan medoxomil tablets; amlodipine and olmesartan medoxomil tablets administered orally, once daily for up to 20 weeks; Other Names: AZOR Tablets ; Drug: hydrochlorothiazide tablets; hydrochlorothiazide tablets may be administered orally, if necessary once daily, for up to 8 weeks

Outcome Measures

Primary Outcome Measures

1. The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks [baseline to 12 weeks]

Secondary Outcome Measures

1. The Percentage of Subjects Achieving Seated Diastolic BP Goal (<90 mmHg for Non-diabetics or < 80 mmHg for Subjects With Diabetes) From Baseline to 12 Weeks [baseline to 12 weeks]

2. The Percentage of Subjects Who Achieve BP Goal (<140/90 mmHg for Non-diabetics or <130/80 mmHg for Diabetics) From Baseline to 12 and 20 Weeks [Baseline to 12 and 20 weeks]

3. Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

4. Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

5. Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

6. Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

7. Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

8. Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

9. Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

10. Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks [Baseline to 12 weeks]

    Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.

11. Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks [Baseline to 20 weeks]

    Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.

12. Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks [Baseline to 12 weeks]

    Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10p.m. - 6 a.m.

13. Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks [Baseline to 20 weeks]

    Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10 p.m. - 6 a.m.

14. Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks [Baseline to 12 weeks]

    Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.

15. Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks [Baseline to 20 weeks]

    Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.

16. Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values [Baseline to 12 weeks]

    Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.

17. Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values [Baseline to 20 weeks]

    Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.

18. Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

19. Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

20. Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

21. Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

22. Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

23. Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

24. Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

25. Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

26. Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

27. Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

28. Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

29. Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

30. Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

31. Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

32. Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

33. Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

34. Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

35. Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

36. Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

37. Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

38. Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

39. Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

40. Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

41. Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

42. Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

43. Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

44. Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

45. Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

46. Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [Baseline to 4, 8, 12, 16, 20 weeks]

47. Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks [Baseline to 12 weeks]

48. Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks [Baseline to 20 weeks]

49. Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks [Baseline to 12 weeks]

50. Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks [Baseline to 20 weeks]

51. Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks [Baseline to 12 weeks]

52. Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks [Baseline to 20 weeks]

53. Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks [Baseline to 12 weeks]

54. Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks [Baseline to 20 weeks]

55. Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks [Baseline to 12 weeks]

56. Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks [Baseline to 20 weeks]

57. Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks [Baseline to 12 weeks]

58. Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks [Baseline to 20 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• = to 18 years of age

• Hypertension uncontrolled on current monotherapy

• Females:

• negative serum pregnancy test at screening

• post menopausal or have had a hysterectomy or tubal ligation or practicing approved methods of birth control

Exclusion Criteria:

• Pregnant females

• Uncontrolled hypertension with multiple drugs, except for hydrochlorothiazide/triamterene

• Diabetes requiring insulin

• Serious disorders that may limit the ability to evaluate the efficacy or safety of treatment

• History of myocardial infarction, bypass graft, angioplasty or heart failure within the past 6 months

• History of Class III or IV congestive heart failure

• History of stroke or transient ischemic attack within the last 1 year

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States
2		Green Valley	Arizona	United States
3		Mesa	Arizona	United States
4		Sierra Vista	Arizona	United States
5		Tempe	Arizona	United States
6		Tucson	Arizona	United States
7		Anaheim	California	United States
8		Harbor City	California	United States
9		National City	California	United States
10		Tustin	California	United States
11		Westlake Village	California	United States
12		Colorado Springs	Colorado	United States
13		Pueblo	Colorado	United States
14		Milford	Connecticut	United States
15		Boynton Beach	Florida	United States
16		Brooksville	Florida	United States
17		Clearwater	Florida	United States
18		Deerfield Beach	Florida	United States
19		DeLand	Florida	United States
20		Fort Lauderdale	Florida	United States
21		Kissimmee	Florida	United States
22		Pembroke Pines	Florida	United States
23		Saint Petersburg	Florida	United States
24		Sarasota	Florida	United States
25		Tampa	Florida	United States
26		Boise	Idaho	United States
27		Addison	Illinois	United States
28		Orland Park	Illinois	United States
29		Wichita	Kansas	United States
30		Lexington	Kentucky	United States
31		Columbia	Maryland	United States
32		Elkridge	Maryland	United States
33		Oxon Hill	Maryland	United States
34		Reisterstown	Maryland	United States
35		Stevensville	Michigan	United States
36		Omaha	Nebraska	United States
37		Las Vegas	Nevada	United States
38		Edison	New Jersey	United States
39		Sewell	New Jersey	United States
40		Albuquerque	New Mexico	United States
41		Binghamton	New York	United States
42		Cary	North Carolina	United States
43		Charlotte	North Carolina	United States
44		Harrisburg	North Carolina	United States
45		Hickory	North Carolina	United States
46		High Point	North Carolina	United States
47		Raleigh	North Carolina	United States
48		Wilmington	North Carolina	United States
49		Winston-Salem	North Carolina	United States
50		Cincinnati	Ohio	United States
51		Cleveland	Ohio	United States
52		Norman	Oklahoma	United States
53		Oklahoma City	Oklahoma	United States
54		Tulsa	Oklahoma	United States
55		Eugene	Oregon	United States
56		Portland	Oregon	United States
57		Havertown	Pennsylvania	United States
58		Jenkintown	Pennsylvania	United States
59		Pittsburgh	Pennsylvania	United States
60		Greenville	South Carolina	United States
61		Mount Pleasant	South Carolina	United States
62		New Tazewell	Tennessee	United States
63		Amarillo	Texas	United States
64		Austin	Texas	United States
65		Carrollton	Texas	United States
66		Corpus Christi	Texas	United States
67		Dallas	Texas	United States
68		Longview	Texas	United States
69		West Jordan	Utah	United States
70		Norfolk	Virginia	United States
71		Walla Walla	Washington	United States
72		Madison	Wisconsin	United States

Sponsors and Collaborators

• Daiichi Sankyo, Inc.
• Integrium

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00791258
• Other Study ID Numbers: CS8663-404
• First Posted: Nov 14, 2008
• Last Update Posted: Jan 9, 2019
• Last Verified: Sep 1, 2010

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Hypertension; Amlodipine; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil

Study Results

Participant Flow

Recruitment Details	Recruitment occurred at approximately 140 outpatient medical clinics in the United States and South Africa from December 2008 through March 2009. 1406 uncontrolled hypertensive subjects were screened to place 999 subjects into active treatment.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Period Title: Overall Study
STARTED	999
COMPLETED	736
NOT COMPLETED	263

Baseline Characteristics

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Overall Participants	999
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	771 77.2%
>=65 years	228 22.8%
Sex: Female, Male (Count of Participants)
Female	491 49.1%
Male	508 50.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	6 0.6%
Asian	129 12.9%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	234 23.4%
White	630 63.1%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	732 73.3%
South Africa	267 26.7%
Hispanic or Latino (Number) [Number]
Hispanic or Latino	105 10.5%
Non-Hispanic or Latino	894 89.5%
Type 2 Diabetes (Number) [Number]
Yes	192 19.2%
No	807 80.8%
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	88.20 (21.466)
Body Mass Index (Kg/m٨2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg/m٨2]	31.02 (6.370)
Metabolic syndrome (Number) [Number]
Yes	462 46.2%
No	537 53.8%
Mean seated systolic blood pressure (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	153.66 (9.178)
Mean seated diastolic blood pressure (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	91.92 (8.616)
Pulse rate (beats/minute) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [beats/minute]	74.77 (11.621)
24-Hour mean systolic ambulatory blood pressure (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	135.74 (11.698)
24-Hour mean diastolic ambulatory blood pressure (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	81.09 (9.346)

Outcome Measures

1. Primary Outcome

Title	The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks
Time Frame	baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	985
Number [Percentage of participants]	75.8 7.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage
	Estimated Value	75.8
	Confidence Interval	(2-Sided) 95%; 73.0 to 78.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	The Percentage of Subjects Achieving Seated Diastolic BP Goal (<90 mmHg for Non-diabetics or < 80 mmHg for Subjects With Diabetes) From Baseline to 12 Weeks
Time Frame	baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	985
Number [Percentage of participants]	84.3 8.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage
	Estimated Value	84.3
	Confidence Interval	(2-Sided) 95%; 81.8 to 86.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	The Percentage of Subjects Who Achieve BP Goal (<140/90 mmHg for Non-diabetics or <130/80 mmHg for Diabetics) From Baseline to 12 and 20 Weeks
Time Frame	Baseline to 12 and 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	985
12 weeks	71.3 7.1%
20 weeks	84.8 8.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	12 week analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage
	Estimated Value	71.3
	Confidence Interval	(2-Sided) 95%; 68.3 to 74.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	20 week analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage
	Estimated Value	84.8
	Confidence Interval	(2-Sided) 95%; 82.4 to 87.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those participants who have a baseline and at lease 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	975
4 weeks, N=975	-14.6 (0.42)
8 weeks, N=929	-16.6 (0.46)
12 weeks, N=865	-21.8 (0.46)
16 weeks, N=797	-26.0 (0.51)
20 weeks, N=745	-26.8 (0.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	4 week analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	-14.6
	Confidence Interval	(2-Sided) 95%; -15.4 to -13.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	8 week analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-16.6
	Confidence Interval	(2-Sided) 95%; -17.7 to -15.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	12 week analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-21.8
	Confidence Interval	(2-Sided) 95%; -22.7 to -20.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	16 week analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-26.0
	Confidence Interval	(2-Sided) 95%; -27.0 to -25.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	20 week analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-26.8
	Confidence Interval	(2-Sided) 95%; -27.8 to -25.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	975
4 weeks, N=975	-8.1 (0.27)
8 weeks, N=929	-9.1 (0.29)
12 weeks, N=865	-11.9 (0.28)
16 weeks, N=797	-14.6 (0.31)
20 weeks, N=745	-14.5 (0.34)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	4 week analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.1
	Confidence Interval	(2-Sided) 95%; -8.6 to -7.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	8 week analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-9.1
	Confidence Interval	(2-Sided) 95%; -9.7 to -8.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	12 week analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-11.9
	Confidence Interval	(2-Sided) 95%; -12.5 to -11.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	16 week analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-14.6
	Confidence Interval	(2-Sided) 95%; -15.2 to -14.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	20 week analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-14.5
	Confidence Interval	(2-Sided) 95%; -15.1 to -13.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	975
4 weeks: <90 mm Hg, N=975	71.3 7.1%
4weeks: <85 mm Hg, N=975	55.2 5.5%
4 weeks: <80 mm Hg, N=975	34.2 3.4%
8 weeks: <90 mm Hg, N=929	75.1 7.5%
8 weeks: <85 mm Hg, N=929	57.1 5.7%
8 weeks: <80 mm Hg, N=929	40.2 4%
12 weeks: <90 mm Hg, N=865	84.3 8.4%
12 weeks: <85 mm Hg, N=865	68.7 6.9%
12 weeks: <80 mm Hg, N=865	49.5 5%
16 weeks: <90 mm Hg, N=797	90.2 9%
16 weeks: <85 mm Hg, N=797	76.9 7.7%
16 weeks: <80 mm Hg, N=797	59.6 6%
20 weeks: <90 mm Hg, N=745	89.7 9%
20 weeks: <85 mm Hg, N=745	79.5 8%
20 weeks: <80 mm Hg, N=745	62.0 6.2%

7. Secondary Outcome

Title	Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	975
4 weeks: <140 mm Hg, N=975	54.2 5.4%
4 weeks: <135 mm Hg, N=975	39.8 4%
4 weeks: <130 mm Hg, N=975	25.3 2.5%
4 weeks: <120 mm Hg, N=975	8.9 0.9%
8 weeks: <140 mm Hg, N=929	57.2 5.7%
8 weeks: <135 mm Hg, N=929	45.9 4.6%
8 weeks: <130 mm Hg, N=929	35.0 3.5%
8 weeks: <120 mm Hg, N=929	12.9 1.3%
12 weeks: <140 mm Hg, N=865	72.6 7.3%
12 weeks: <135 mm Hg, N=865	59.0 5.9%
12 weeks: <130 mm Hg, N=865	45.3 4.5%
12 weeks: <120 mm Hg, N=865	19.4 1.9%
16 weeks: <140 mm Hg, N=797	80.9 8.1%
16 weeks: <135 mm Hg, N=797	70.3 7%
16 weeks: <130 mm Hg, N=797	58.9 5.9%
16 weeks: <120 mm Hg, N=797	30.9 3.1%
20 weeks: <140 mm Hg, N=745	84.3 8.4%
20 weeks: <135 mm Hg, N=745	75.2 7.5%
20 weeks: <130 mm Hg, N=745	64.2 6.4%
20 weeks: <120 mm Hg, N=745	31.5 3.2%

8. Secondary Outcome

Title	Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	975
4 weeks: <140/90 mm Hg, N=975	49.1 4.9%
4 weeks: <135/80 mm Hg, N=975	23.0 2.3%
4 weeks: <130/80 mm Hg, N=975	17.3 1.7%
4 weeks: <120/80 mm Hg, N=975	7.8 0.8%
8 weeks: <140/90 mm Hg, N=929	52.4 5.2%
8 weeks: <135/80 mm Hg, N=929	29.8 3%
8 weeks: <130/80 mm Hg, N=929	24.8 2.5%
8 weeks: <120/80 mm Hg, N=929	11.2 1.1%
12 weeks: <140/90 mm Hg, N=865	68.1 6.8%
12 weeks: <135/80 mm Hg, N=865	40.0 4%
12 weeks: <130/80 mm Hg, N=865	34.3 3.4%
12 weeks: <120/80 mm Hg, N=865	17.6 1.8%
16 weeks: <140/90mm Hg, N=797	77.8 7.8%
16 weeks: <135/80mm Hg, N=797	51.3 5.1%
16 weeks: <130/80mm Hg, N=797	46.2 4.6%
16 weeks: <120/80mm Hg, N=797	28.7 2.9%
20 weeks: <140/90 mm Hg, N=745	81.3 8.1%
20 weeks: <135/80 mm Hg, N=745	55.6 5.6%
20 weeks: <130/80 mm Hg, N=745	50.1 5%
20 weeks: <120/80 mm Hg, N=745	28.2 2.8%

9. Secondary Outcome

Title	Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	975
4 weeks: ≤ 15 mm Hg, N=975	51.4 5.1%
4 weeks: >15 and ≤ 30 mm Hg, N=975	36.6 3.7%
4 weeks: >30 and ≤ 45 mm Hg, N=975	10.5 1.1%
4 weeks: >45 mm Hg, N=975	1.5 0.2%
8 weeks: ≤ 15 mm Hg, N=929	45.8 4.6%
8 weeks: >15 and ≤ 30 mm Hg, N=929	37.7 3.8%
8 weeks: >30 and ≤ 45 mm Hg, N=929	14.3 1.4%
8 weeks: >45 mm Hg, N=929	2.3 0.2%
12 weeks: ≤ 15 mm Hg, N=865	30.5 3.1%
12 weeks: >15 and ≤ 30 mm Hg, N=865	43.1 4.3%
12 weeks: >30 and ≤ 45 mm Hg, N=865	22.4 2.2%
12 weeks: >45 mm Hg, N=865	3.9 0.4%
16 weeks: ≤ 15 mm Hg, N=797	23.2 2.3%
16 weeks: >15 and ≤ 30 mm Hg, N=797	35.9 3.6%
16 weeks: >30 and ≤ 45 mm Hg, N=797	32.0 3.2%
16 weeks: >45 mm Hg, N=797	8.9 0.9%
20 weeks: ≤ 15 mm Hg, N=745	20.4 2%
20 weeks: >15 and ≤ 30 mm Hg, N=745	36.2 3.6%
20 weeks: >30 and ≤ 45 mm Hg, N=745	34.0 3.4%
20 weeks: >45 mm Hg, N=745	9.4 0.9%

10. Secondary Outcome

Title	Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	975
4 weeks: ≤ 10 mm Hg, N=975	61.3 6.1%
4 weeks: >10 and ≤ 15 mm Hg, N=975	21.0 2.1%
4 weeks: >15 and ≤ 20 mm Hg, N=975	10.5 1.1%
4 weeks: >20 mm Hg, N=975	7.2 0.7%
8 weeks: ≤ 10 mm Hg, N=929	54.7 5.5%
8 weeks: >10 and ≤ 15 mm Hg, N=929	20.7 2.1%
8 weeks: >15 and ≤ 20 mm Hg, N=929	14.1 1.4%
8 weeks: >20 mm Hg, N=929	10.6 1.1%
12 weeks: ≤ 10 mm Hg, N=865	43.8 4.4%
12 weeks: >10 and ≤ 15 mm Hg, N=865	24.1 2.4%
12 weeks: >15 and ≤ 20 mm Hg, N=865	15.8 1.6%
12 weeks: >20 mm Hg, N=865	16.3 1.6%
16 weeks: ≤ 10 mm Hg, N=797	30.4 3%
16 weeks: >10 and ≤ 15 mm Hg, N=797	22.8 2.3%
16 weeks: >15 and ≤ 20 mm Hg, N=797	21.5 2.2%
16 weeks: >20 mm Hg, N=797	25.4 2.5%
20 weeks: ≤ 10 mm Hg, N=745	31.4 3.1%
20 weeks: >10 and ≤ 15 mm Hg, N=745	19.9 2%
20 weeks: >15 and ≤ 20 mm Hg, N=745	22.6 2.3%
20 weeks: >20 mm Hg, N=745	26.2 2.6%

11. Secondary Outcome

Title	Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks
Description	Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	229
Daytime mean systolic blood pressure <140 mmHg	88.2 8.8%
Daytime mean systolic blood pressure <135 mmHg	79.9 8%
Daytime mean systolic blood pressure <130 mmHg	66.4 6.6%
Daytime mean systolic blood pressure <120 mmHg	28.8 2.9%
Daytime mean diastolic blood pressure <90 mmHg	95.6 9.6%
Daytime mean diastolic blood pressure <85 mmHg	83.0 8.3%
Daytime mean diastolic blood pressure <80 mmHg	65.5 6.6%
Daytime mean blood pressure <140/90 mmHg	86.9 8.7%
Daytime mean blood pressure <135/95 mmHg	72.9 7.3%
Daytime mean blood pressure <135/80 mmHg	61.1 6.1%
Daytime mean blood pressure <130/80 mmHg	53.3 5.3%
Daytime mean blood pressure <125/75 mmHg	31.9 3.2%
Daytime mean blood pressure <120/80 mmHg	27.9 2.8%
Daytime mean blood pressure <120/70 mmHg	13.1 1.3%

12. Secondary Outcome

Title	Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks
Description	Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.
Time Frame	Baseline to 20 weeks

Outcome Measure Data

Analysis Population Description

Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	199
Daytime mean systolic blood pressure <140 mmHg	96.5 9.7%
Daytime mean systolic blood pressure <135 mmHg	93.5 9.4%
Daytime mean systolic blood pressure <130 mmHg	83.9 8.4%
Daytime mean systolic blood pressure <120 mmHg	51.8 5.2%
Daytime mean diastolic blood pressure <90 mmHg	98.5 9.9%
Daytime mean diastolic blood pressure <85 mmHg	92.5 9.3%
Daytime mean diastolic blood pressure <80 mmHg	83.9 8.4%
Daytime mean blood pressure <140/90 mmHg	95.0 9.5%
Daytime mean blood pressure <135/95 mmHg	88.4 8.8%
Daytime mean blood pressure <135/80 mmHg	81.9 8.2%
Daytime mean blood pressure <130/80 mmHg	77.4 7.7%
Daytime mean blood pressure <125/75 mmHg	56.8 5.7%
Daytime mean blood pressure <120/80 mmHg	51.3 5.1%
Daytime mean blood pressure <120/70 mmHg	33.2 3.3%

13. Secondary Outcome

Title	Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks
Description	Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10p.m. - 6 a.m.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	229
Nighttime mean systolic blood pressure <140 mmHg	97.8 9.8%
Nighttime mean systolic blood pressure <135 mmHg	94.3 9.4%
Nighttime mean systolic blood pressure <130 mmHg	92.6 9.3%
Nighttime mean systolic blood pressure <120 mmHg	74.7 7.5%
Nighttime mean diastolic blood pressure <90 mmHg	99.6 10%
Nighttime mean diastolic blood pressure <85 mmHg	98.3 9.8%
Nighttime mean diastolic blood pressure <80 mmHg	94.8 9.5%
Nighttime mean blood pressure <140/90 mmHg	97.4 9.7%
Nighttime mean blood pressure <135/95 mmHg	93.4 9.3%
Nighttime mean blood pressure <135/80 mmHg	90.8 9.1%
Nighttime mean blood pressure <130/80 mmHg	89.1 8.9%
Nighttime mean blood pressure <125/75 mmHg	77.7 7.8%
Nighttime mean blood pressure <120/80 mmHg	74.2 7.4%
Nighttime mean blood pressure <120/70 mmHg	62.0 6.2%

14. Secondary Outcome

Title	Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks
Description	Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10 p.m. - 6 a.m.
Time Frame	Baseline to 20 weeks

Outcome Measure Data

Analysis Population Description

Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	199
Nighttime mean systolic blood pressure <140 mmHg	99.5 10%
Nighttime mean systolic blood pressure <135 mmHg	99.5 10%
Nighttime mean systolic blood pressure <130 mmHg	97.5 9.8%
Nighttime mean systolic blood pressure <120 mmHg	86.4 8.6%
Nighttime mean diastolic blood pressure <90 mmHg	99.5 10%
Nighttime mean diastolic blood pressure <85 mmHg	98.5 9.9%
Nighttime mean diastolic blood pressure <80 mmHg	96.0 9.6%
Nighttime mean blood pressure <140/90 mmHg	99.0 9.9%
Nighttime mean blood pressure <135/95 mmHg	98.5 9.9%
Nighttime mean blood pressure <135/80 mmHg	96.0 9.6%
Nighttime mean blood pressure <130/80 mmHg	95.0 9.5%
Nighttime mean blood pressure <125/75 mmHg	88.9 8.9%
Nighttime mean blood pressure <120/80 mmHg	85.9 8.6%
Nighttime mean blood pressure <120/70 mmHg	78.9 7.9%

15. Secondary Outcome

Title	Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks
Description	Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	229
24-hour mean systolic blood pressure <140 mmHg	95.6 9.6%
24-hour mean systolic blood pressure <135 mmHg	90.4 9%
24-hour mean systolic blood pressure <130 mmHg	79.9 8%
24-hour mean systolic blood pressure <120 mmHg	47.2 4.7%
24-hour mean diastolic blood pressure <90 mmHg	98.7 9.9%
24-hour mean diastolic blood pressure <85 mmHg	96.1 9.6%
24-hour mean diastolic blood pressure <80 mmHg	84.7 8.5%
24-hour mean blood pressure <140/90 mmHg	94.3 9.4%
24-hour mean blood pressure <135/95 mmHg	89.1 8.9%
24-hour mean blood pressure <135/80 mmHg	80.3 8%
24-hour mean blood pressure <130/80 mmHg	73.4 7.3%
24-hour mean blood pressure <125/75 mmHg	52.4 5.2%
24-hour mean blood pressure <120/80 mmHg	45.9 4.6%
24-hour mean blood pressure <120/70 mmHg	27.5 2.8%

16. Secondary Outcome

Title	Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks
Description	Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.
Time Frame	Baseline to 20 weeks

Outcome Measure Data

Analysis Population Description

Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	199
24-hour mean systolic blood pressure <140 mmHg	99.5 10%
24-hour mean systolic blood pressure <135 mmHg	97.5 9.8%
24-hour mean systolic blood pressure <130 mmHg	94.5 9.5%
24-hour mean systolic blood pressure <120 mmHg	70.4 7%
24-hour mean diastolic blood pressure <90 mmHg	100.0 10%
24-hour mean diastolic blood pressure <85 mmHg	97.5 9.8%
24-hour mean diastolic blood pressure <80 mmHg	93.0 9.3%
24-hour mean blood pressure <140/90 mmHg	99.5 10%
24-hour mean blood pressure <135/95 mmHg	96.0 9.6%
24-hour mean blood pressure <135/80 mmHg	92.5 9.3%
24-hour mean blood pressure <130/80 mmHg	90.5 9.1%
24-hour mean blood pressure <125/75 mmHg	75.4 7.5%
24-hour mean blood pressure <120/80 mmHg	70.4 7%
24-hour mean blood pressure <120/70 mmHg	55.3 5.5%

17. Secondary Outcome

Title	Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values
Description	Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	229
24-hour mean systolic blood pressure	-14.8 (0.72)
Mean daytime systolic blood pressure	-16.3 (0.77)
Mean nighttime systolic blood pressure	-12.5 (0.84)
Systolic blood pressure - last 2 hours of dose	-13.6 (1.04)
Systolic blood pressure - last 4 hours of dose	-13.0 (0.90)
Systolic blood pressure - last 6 hours of dose	-12.6 (0.85)
24-hour mean diastolic blood pressure	-9.4 (0.46)
Mean daytime diastolic blood pressure	-10.6 (0.51)
Mean nighttime diastolic blood pressure	-7.6 (0.59)
Diastolic blood pressure - last 2 hours of dose	-8.6 (0.70)
Diastolic blood pressure - last 4 hours of dose	-8.0 (0.60)
Diastolic blood pressure - last 6 hours of dose	-7.7 (0.57)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	Mean 24-hour systolic blood pressure
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-14.8
	Confidence Interval	(2-Sided) 95%; -16.2 to -13.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	Mean daytime systolic blood pressure
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-16.3
	Confidence Interval	(2-Sided) 95%; -17.8 to -14.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	Mean nighttime systolic blood pressure
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-12.5
	Confidence Interval	(2-Sided) 95%; -14.1 to -10.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	systolic blood pressure during last 2 hours of dose
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-13.6
	Confidence Interval	(2-Sided) 95%; -15.7 to -11.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	systolic blood pressure during last 4 hours of dose
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-13.0
	Confidence Interval	(2-Sided) 95%; -14.7 to -11.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	systolic blood pressure during last 6 hours of dose
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-12.6
	Confidence Interval	(2-Sided) 95%; -14.3 to -10.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	Mean 24-hour diastolic blood pressure
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-9.4
	Confidence Interval	() 95%; -10.3 to -8.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	Mean daytime diastolic blood pressure
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-10.6
	Confidence Interval	(2-Sided) 95%; -11.7 to -9.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	Mean nighttime diastolic blood pressure
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-7.6
	Confidence Interval	(2-Sided) 95%; -8.8 to -6.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	diastolic blood pressure during last 2 hours of dose
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.6
	Confidence Interval	() 95%; -10.0 to -7.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	diastolic blood pressure during last 4 hours of dose
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.0
	Confidence Interval	(2-Sided) 95%; -9.2 to -6.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	diastolic blood pressure during last 6 hours of dose
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-7.7
	Confidence Interval	() 95%; -8.8 to -6.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

18. Secondary Outcome

Title	Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values
Description	Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.
Time Frame	Baseline to 20 weeks

Outcome Measure Data

Analysis Population Description

Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	199
24-hour mean systolic blood pressure	-21.0 (0.84)
Mean daytime systolic blood pressure	-23.2 (0.94)
Mean nighttime systolic blood pressure	-17.5 (0.94)
Systolic blood pressure - last 2 hours of dose	-19.6 (1.10)
Systolic blood pressure - last 4 hours of dose	-18.2 (1.00)
Systolic blood pressure - last 6 hours of dose	-17.9 (0.95)
24-hour mean diastolic blood pressure	-13.3 (0.55)
Mean daytime diastolic blood pressure	-15.0 (0.62)
Mean nighttime diastolic blood pressure	-11.1 (0.69)
Diastolic blood pressure - last 2 hours of dose	-12.3 (0.77)
Diastolic blood pressure - last 4 hours of dose	-11.6 (0.69)
Diastolic blood pressure - last 6 hours of dose	-11.3 (0.66)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	24-hour mean systolic blood pressure
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-21.0
	Confidence Interval	(2-Sided) 95%; -22.6 to -19.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	Mean daytime systolic blood pressure
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-23.2
	Confidence Interval	(2-Sided) 95%; -25.1 to -21.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	Mean nighttime systolic blood pressure
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-17.5
	Confidence Interval	(2-Sided) 95%; -19.4 to -15.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	Systolic blood pressure - last 2 hours of dose
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-19.6
	Confidence Interval	(2-Sided) 95%; -21.7 to -17.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	Systolic blood pressure - last 4 hours of dose
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-18.2
	Confidence Interval	(2-Sided) 95%; -20.2 to -16.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	Systolic blood pressure - last 6 hours of dose
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-17.9
	Confidence Interval	(2-Sided) 95%; -19.7 to -16.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	24-hour mean diastolic blood pressure
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-13.3
	Confidence Interval	(2-Sided) 95%; -14.4 to -12.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	Mean daytime diastolic blood pressure
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-15.0
	Confidence Interval	(2-Sided) 95%; -16.2 to -13.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	Mean nighttime diastolic blood pressure
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-11.1
	Confidence Interval	(2-Sided) 95%; -12.4 to -9.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	Diastolic blood pressure - last 2 hours of dose
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-12.3
	Confidence Interval	(2-Sided) 95%; -13.8 to -10.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	Diastolic blood pressure - last 4 hours of dose
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-11.6
	Confidence Interval	(2-Sided) 95%; -12.9 to -10.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Comments	Diastolic blood pressure - last 6 hours of dose
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-11.3
	Confidence Interval	(2-Sided) 95%; -12.6 to -10.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

19. Secondary Outcome

Title	Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	230
4 weeks: <140 mm Hg, N=230	51.7 5.2%
4 weeks: <135 mm Hg, N=230	34.4 3.4%
4 weeks: <130 mm Hg, N=230	19.6 2%
4 weeks: <120 mm Hg, N=230	5.7 0.6%
8 weeks: <140 mm Hg, N=231	62.3 6.2%
8 weeks: <135 mm Hg, N=231	44.6 4.5%
8 weeks: <130 mm Hg, N=231	33.8 3.4%
8 weeks: <120 mm Hg, N=231	13.0 1.3%
12 weeks: <140 mm Hg, N=232	76.3 7.6%
12 weeks: <135 mm Hg, N=232	59.1 5.9%
12 weeks: <130 mm Hg, N=232	47.0 4.7%
12 weeks: <120 mm Hg, N=232	19.8 2%
16 weeks: <140 mm Hg, N=232	84.9 8.5%
16 weeks: <135 mm Hg, N=232	71.1 7.1%
16 weeks: <130 mm Hg, N=232	61.2 6.1%
16 weeks: <120 mm Hg, N=232	34.1 3.4%
20 weeks: <140 mm Hg, N=232	91.0 9.1%
20 weeks: <135 mm Hg, N=232	80.6 8.1%
20 weeks: <130 mm Hg, N=232	71.1 7.1%
20 weeks: <120 mm Hg, N=232	44.4 4.4%

20. Secondary Outcome

Title	Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	230
4 weeks: <90 mm Hg, N=230	60.9 6.1%
4 weeks: <85 mm Hg, N=230	42.2 4.2%
4 weeks: <80 mm Hg, N=230	19.6 2%
8 weeks: <90 mm Hg, N=231	71.9 7.2%
8 weeks: <85 mm Hg, N=231	53.7 5.4%
8 weeks: <80 mm Hg, N=231	30.3 3%
12 weeks: <90 mm Hg, N=232	82.3 8.2%
12 weeks: <85 mm Hg, N=232	66.0 6.6%
12 weeks: <80 mm Hg, N=232	45.3 4.5%
16 weeks: <90 mm Hg, N=232	92.2 9.2%
16 weeks: <85 mm Hg, N=232	76.3 7.6%
16 weeks: <80 mm Hg, N=232	55.2 5.5%
20 weeks: <90 mm Hg, N=232	94.8 9.5%
20 weeks: <85 mm Hg, N=232	80.6 8.1%
20 weeks: <80 mm Hg, N=232	61.2 6.1%

21. Secondary Outcome

Title	Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	230
4 weeks: <140/90 mm Hg, N=230	45.7 4.6%
4 weeks: <135/80 mm Hg, N=230	14.8 1.5%
4 weeks: <130/80 mm Hg, N=230	10.4 1%
4 weeks: <120/80 mm Hg, N=230	3.9 0.4%
8 weeks: <140/90 mm Hg, N=231	55.0 5.5%
8 weeks: <135/80 mm Hg, N=231	23.8 2.4%
8 weeks: <130/80 mm Hg, N=232	20.8 2.1%
8 weeks: <120/80 mm Hg, N=232	10.4 1%
12 weeks: <140/90mm Hg, N=232	68.5 6.9%
12 weeks: <135/80 mm Hg, N=232	38.4 3.8%
12 weeks: <130/80 mm Hg, N=232	35.8 3.6%
12 weeks: <120/80 mm Hg, N=232	16.4 1.6%
16 weeks: <140/90 mm Hg, N=232	80.6 8.1%
16 weeks: <135/80 mm Hg, N=232	49.1 4.9%
16 weeks: <130/80 mm Hg, N=232	47.4 4.7%
16 weeks: <120/80 mm Hg, N=232	30.6 3.1%
20 weeks: <140/90 mm Hg, N=232	86.6 8.7%
20 weeks: <135/80 mm Hg, N=232	57.8 5.8%
20 weeks: <130/80 mm Hg, N=232	55.2 5.5%
20 weeks: <120/80 mm Hg, N=232	39.7 4%

22. Secondary Outcome

Title	Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	230
4 weeks: ≤ 15 mm Hg, N=230	60.0 6%
4 weeks: >15 and ≤ 30 mm Hg, N=230	32.2 3.2%
4 weeks: >30 and ≤ 45 mm Hg, N=230	7.4 0.7%
4 weeks: >45 mm Hg, N=230	0.4 0%
8 weeks: ≤ 15 mm Hg, N=220	53.6 5.4%
8 weeks: >15 and ≤ 30 mm Hg, N=220	38.2 3.8%
8 weeks: >30 and ≤ 45 mm Hg, N=220	7.3 0.7%
8 weeks: >45 mm Hg, N=220	0.9 0.1%
12 weeks: ≤ 15 mm Hg, N=208	38.9 3.9%
12 weeks: >15 and ≤ 30 mm Hg, N=208	41.8 4.2%
12 weeks: >30 and ≤ 45 mm Hg, N=208	16.4 1.6%
12 weeks: >45 mm Hg, N=208	2.9 0.3%
16 weeks: ≤ 15 mm Hg, N=199	30.7 3.1%
16 weeks: >15 and ≤ 30 mm Hg, N=199	37.2 3.7%
16 weeks: >30 and ≤ 45 mm Hg, N=199	25.1 2.5%
16 weeks: >45 mm Hg, N=199	7.0 0.7%
20 weeks: ≤ 15 mm Hg, N=189	24.3 2.4%
20 weeks: >15 and ≤ 30 mm Hg, N=189	37.6 3.8%
20 weeks: >30 and ≤ 45 mm Hg, N=189	29.6 3%
20 weeks: >45 mm Hg, N=189	8.5 0.9%

23. Secondary Outcome

Title	Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	230
4 weeks: ≤ 10 mm Hg, N=230	70.0 7%
4 weeks: >10 and ≤ 15 mm Hg, N=230	17.8 1.8%
4 weeks: >15 and ≤ 20 mm Hg, N=230	7.9 0.8%
4 weeks: >20 mm Hg, N=230	4.4 0.4%
8 weeks: ≤ 10 mm Hg, N=220	66.8 6.7%
8 weeks: >10 and ≤ 15 mm Hg, N=220	15.0 1.5%
8 weeks: >15 and ≤ 20 mm Hg, N=220	10.9 1.1%
8 weeks: >20 mm Hg, N=220	7.3 0.7%
12 weeks: ≤ 10 mm Hg, N=208	54.8 5.5%
12 weeks: >10 and ≤15 mm Hg, N=208	21.2 2.1%
12 weeks: >15 and ≤ 20 mm Hg, N=208	12.0 1.2%
12 weeks: >20 mm Hg, N=208	12.0 1.2%
16 weeks: ≤ 10 mm Hg, N=199	38.7 3.9%
16 weeks: >10 and ≤ 15 mm Hg, N=199	19.6 2%
16 weeks: >15 and ≤ 20 mm Hg, N=199	23.1 2.3%
16 weeks: >20 mm Hg, N=199	18.6 1.9%
20 weeks: ≤ 10 mm Hg, N=189	36.0 3.6%
20 weeks: >10 and ≤ 15 mm Hg, N=189	19.6 2%
20 weeks: >15 and ≤ 20 mm Hg, N=189	20.6 2.1%
20 weeks: >20 mm Hg, N=189	23.8 2.4%

24. Secondary Outcome

Title	Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	128
4 weeks: <140 mm Hg, N=128	64.8 6.5%
4 weeks: <135 mm Hg, N=128	51.6 5.2%
4 weeks: <130 mm Hg, N=128	35.2 3.5%
4 weeks: <120 mm Hg, N=128	11.7 1.2%
8 weeks: <140 mm Hg, N=128	76.6 7.7%
8 weeks: <135 mm Hg, N=128	67.2 6.7%
8 weeks: <130 mm Hg, N=128	51.6 5.2%
8 weeks: <120 mm Hg, N=128	25.0 2.5%
12 weeks: <140 mm Hg, N=128	89.1 8.9%
12 weeks: <135 mm Hg, N=128	78.9 7.9%
12 weeks: <130 mm Hg, N=128	66.4 6.6%
12 weeks: <120 mm Hg, N=128	38.3 3.8%
16 weeks: <140 mm Hg, N=128	95.3 9.5%
16 weeks: <135 mm Hg, N=128	89.8 9%
16 weeks: <130 mm Hg, N=128	81.3 8.1%
16 weeks: <120 mm Hg, N=128	47.7 4.8%
20 weeks: <140 mm Hg, N=128	97.7 9.8%
20 weeks: <135 mm Hg, N=128	93.0 9.3%
20 weeks: <130 mm Hg, N=128	85.9 8.6%
20 weeks: <120 mm Hg, N=128	51.6 5.2%

25. Secondary Outcome

Title	Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	128
4 weeks: <90 mm Hg, N=128	83.6 8.4%
4 weeks: <85 mm Hg, N=128	69.5 7%
4 weeks: <80 mm Hg, N=128	45.3 4.5%
8 weeks: <90 mm Hg, N=128	89.1 8.9%
8 weeks: <85 mm Hg, N=128	79.7 8%
8 weeks: <80 mm Hg, N=128	60.2 6%
12 weeks: <90 mm Hg, N=128	95.3 9.5%
12 weeks: <85 mm Hg, N=128	87.5 8.8%
12 weeks: <80 mm Hg, N=128	71.1 7.1%
16 weeks: <90 mm Hg, N=128	96.9 9.7%
16 weeks: <85 mm Hg, N=128	93.0 9.3%
16 weeks: <80 mm Hg, N=128	82.0 8.2%
20 weeks: <90 mm Hg, N=128	96.9 9.7%
20 weeks: <85 mm Hg, N=128	93.0 9.3%
20 weeks: <80 mm Hg, N=128	85.2 8.5%

26. Secondary Outcome

Title	Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	126
4 weeks: ≤ 15 mm Hg, N=126	43.7 4.4%
4 weeks: >15 and ≤ 30 mm Hg, N=126	38.1 3.8%
4 weeks: >30 and ≤ 45 mm Hg, N=126	15.9 1.6%
4 weeks: >45 mm Hg, N=126	2.4 0.2%
8 weeks: ≤ 15 mm Hg, N=123	40.7 4.1%
8 weeks: >15 and ≤ 30 mm Hg, N=123	35.8 3.6%
8 weeks: >30 and ≤ 45 mm Hg, N=123	22.0 2.2%
8 weeks: >45 mm Hg, N=123	1.6 0.2%
12 weeks: ≤ 15 mm Hg, N=120	28.3 2.8%
12 weeks: >15 and ≤ 30 mm Hg, N=120	39.2 3.9%
12 weeks: >30 and ≤ 45 mm Hg, N=120	27.5 2.8%
12 weeks: >45 mm Hg, N=120	5.0 0.5%
16 weeks: ≤ 15 mm Hg, N=112	20.5 2.1%
16 weeks: >15 and ≤ 30 mm Hg, N=112	36.6 3.7%
16 weeks: >30 and ≤ 45 mm Hg, N=112	31.3 3.1%
16 weeks: >45 mm Hg, N=112	11.6 1.2%
20 weeks: ≤ 15 mm Hg, N=105	29.5 3%
20 weeks: >15 and ≤ 30 mm Hg, N=105	28.6 2.9%
20 weeks: >30 and ≤ 45 mm Hg, N=105	33.3 3.3%
20 weeks: >45 mm Hg, N=105	8.6 0.9%

27. Secondary Outcome

Title	Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	126
4 weeks: ≤ 10 mm Hg, N=126	47.6 4.8%
4 weeks: >10 and ≤ 15 mm Hg, N=126	26.2 2.6%
4 weeks: >15 and ≤ 20 mm Hg, N=126	13.5 1.4%
4 weeks: >20 mm Hg, N=126	12.7 1.3%
8 weeks: ≤ 10 mm Hg, N=123	38.2 3.8%
8 weeks: >10 and ≤ 15 mm Hg, N=123	24.4 2.4%
8 weeks: >15 and ≤ 20 mm Hg, N=123	22.0 2.2%
8 weeks: >20 mm Hg, N=123	15.5 1.6%
12 weeks: ≤ 10 mm Hg, N=120	33.3 3.3%
12 weeks: >10 and ≤15 mm Hg, N=120	25.8 2.6%
12 weeks: >15 and ≤ 20 mm Hg, N=120	19.2 1.9%
12 weeks: >20 mm Hg, N=120	21.7 2.2%
16 weeks: ≤ 10 mm Hg, N=112	27.7 2.8%
16 weeks: >10 and ≤ 15 mm Hg, N=112	17.0 1.7%
16 weeks: >15 and ≤ 20 mm Hg, N=112	20.5 2.1%
16 weeks: >20 mm Hg, N=112	34.8 3.5%
20 weeks: ≤ 10 mm Hg, N=105	36.2 3.6%
20 weeks: >10 and ≤ 15 mm Hg, N=105	16.2 1.6%
20 weeks: >15 and ≤ 20 mm Hg, N=105	18.1 1.8%
20 weeks: >20 mm Hg, N=105	29.5 3%

28. Secondary Outcome

Title	Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	98
4 weeks: <140 mm Hg, N=98	55.1 5.5%
4 weeks: <135 mm Hg, N=98	39.8 4%
4 weeks: <130 mm Hg, N=98	31.6 3.2%
4 weeks: <120 mm Hg, N=98	10.2 1%
8 weeks: <140 mm Hg, N=100	64.0 6.4%
8 weeks: <135 mm Hg, N=100	51.0 5.1%
8 weeks: <130 mm Hg, N=100	41.0 4.1%
8 weeks: <120 mm Hg, N=100	15.0 1.5%
12 weeks: <140 mm Hg, N=100	77.0 7.7%
12 weeks: <135 mm Hg, N=100	67.0 6.7%
12 weeks: <130 mm Hg, N=100	54.0 5.4%
12 weeks: <120 mm Hg, N=100	30.0 3%
16 weeks: <140 mm Hg, N=100	84.0 8.4%
16 weeks: <135 mm Hg, N=100	77.0 7.7%
16 weeks: <130 mm Hg, N=100	66.0 6.6%
16 weeks: <120 mm Hg, N=100	37.0 3.7%
20 weeks: <140 mm Hg, N=100	88.0 8.8%
20 weeks: <135 mm Hg, N=100	83.0 8.3%
20 weeks: <130 mm Hg, N=100	72.0 7.2%
20 weeks: <120 mm Hg, N=100	41.0 4.1%

29. Secondary Outcome

Title	Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	98
4 weeks: <90 mm Hg, N=98	66.3 6.6%
4 weeks: <85 mm Hg, N=98	53.1 5.3%
4 weeks: <80 mm Hg, N=98	34.7 3.5%
8 weeks: <90 mm Hg, N=100	85.0 8.5%
8 weeks: <85 mm Hg, N=100	70.0 7%
8 weeks: <80 mm Hg, N=100	48.0 4.8%
12 weeks: <90 mm Hg, N=100	92.0 9.2%
12 weeks: <85 mm Hg, N=100	78.0 7.8%
12 weeks: <80 mm Hg, N=100	62.0 6.2%
16 weeks: <90 mm Hg, N=100	96.0 9.6%
16 weeks: <85 mm Hg, N=100	90.0 9%
16 weeks: <80 mm Hg, N=100	75.0 7.5%
20 weeks: <90 mm Hg, N=100	96.0 9.6%
20 weeks: <85 mm Hg, N=100	90.0 9%
20 weeks: <80 mm Hg, N=100	75.0 7.5%

30. Secondary Outcome

Title	Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	98
4 weeks: ≤ 15 mm Hg, N=98	50.0 5%
4 weeks: >15 and ≤ 30 mm Hg, N=98	37.8 3.8%
4 weeks: >30 and ≤ 45 mm Hg, N=98	7.1 0.7%
4 weeks: >45 mm Hg, N=98	5.1 0.5%
8 weeks: ≤ 15 mm Hg, N=91	42.9 4.3%
8 weeks: >15 and ≤ 30 mm Hg, N=91	44.0 4.4%
8 weeks: >30 and ≤ 45 mm Hg, N=91	9.9 1%
8 weeks: >45 mm Hg, N=91	3.3 0.3%
12 weeks: ≤ 15 mm Hg, N=83	31.3 3.1%
12 weeks: >15 and ≤ 30 mm Hg, N=83	36.1 3.6%
12 weeks: >30 and ≤ 45 mm Hg, N=83	25.3 2.5%
12 weeks: >45 mm Hg, N=83	7.2 0.7%
16 weeks: ≤ 15 mm Hg, N=75	22.7 2.3%
16 weeks: >15 and ≤ 30 mm Hg, N=75	36.0 3.6%
16 weeks: >30 and ≤ 45 mm Hg, N=75	34.7 3.5%
16 weeks: >45 mm Hg, N=75	6.7 0.7%
20 weeks: ≤ 15 mm Hg, N=71	23.9 2.4%
20 weeks: >15 and ≤ 30 mm Hg, N=71	33.8 3.4%
20 weeks: >30 and ≤ 45 mm Hg, N=71	33.8 3.4%
20 weeks: >45 mm Hg, N=71	8.5 0.9%

31. Secondary Outcome

Title	Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	98
4 weeks: ≤ 10 mm Hg, N=98	65.3 6.5%
4 weeks: >10 and ≤ 15 mm Hg, N=98	16.3 1.6%
4 weeks: >15 and ≤ 20 mm Hg, N=98	8.2 0.8%
4 weeks: >20 mm Hg, N=98	10.2 1%
8 weeks: ≤ 10 mm Hg, N=91	52.8 5.3%
8 weeks: >10 and ≤ 15 mm Hg, N=91	18.7 1.9%
8 weeks: >15 and ≤ 20 mm Hg, N=91	14.3 1.4%
8 weeks: >20 mm Hg, N=91	14.3 1.4%
12 weeks: ≤ 10 mm Hg, N=83	41.0 4.1%
12 weeks: >10 and ≤15 mm Hg, N=83	20.5 2.1%
12 weeks: >15 and ≤ 20 mm Hg, N=83	14.5 1.5%
12 weeks: >20 mm Hg, N=83	24.1 2.4%
16 weeks: ≤ 10 mm Hg, N=75	30.7 3.1%
16 weeks: >10 and ≤ 15 mm Hg, N=75	25.3 2.5%
16 weeks: >15 and ≤ 20 mm Hg, N=75	16.0 1.6%
16 weeks: >20 mm Hg, N=75	28.0 2.8%
20 weeks: ≤ 10 mm Hg, N=71	31.0 3.1%
20 weeks: >10 and ≤ 15 mm Hg, N=71	12.7 1.3%
20 weeks: >15 and ≤ 20 mm Hg, N=71	26.8 2.7%
20 weeks: >20 mm Hg, N=71	29.6 3%

32. Secondary Outcome

Title	Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	227
4 weeks: <140 mm Hg, N=227	52.0 5.2%
4 weeks: <135 mm Hg, N=227	37.9 3.8%
4 weeks: <130 mm Hg, N=227	23.4 2.3%
4 weeks: <120 mm Hg, N=227	9.7 1%
8 weeks: <140 mm Hg, N=227	67.0 6.7%
8 weeks: <135 mm Hg, N=227	57.7 5.8%
8 weeks: <130 mm Hg, N=227	43.6 4.4%
8 weeks: <120 mm Hg, N=227	18.1 1.8%
12 weeks: <140 mm Hg, N=227	80.6 8.1%
12 weeks: <135 mm Hg, N=227	70.0 7%
12 weeks: <130 mm Hg, N=227	56.8 5.7%
12 weeks: <120 mm Hg, N=227	28.6 2.9%
16 weeks: <140 mm Hg, N=227	87.7 8.8%
16 weeks: <135 mm Hg, N=227	79.7 8%
16 weeks: <130 mm Hg, N=227	70.9 7.1%
16 weeks: <120 mm Hg, N=227	43.6 4.4%
20 weeks: <140 mm Hg, N=227	91.6 9.2%
20 weeks: <135 mm Hg, N=227	85.9 8.6%
20 weeks: <130 mm Hg, N=227	78.9 7.9%
20 weeks: <120 mm Hg, N=227	50.7 5.1%

33. Secondary Outcome

Title	Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	227
4 weeks: <90 mm Hg, N=227	88.1 8.8%
4 weeks: <85 mm Hg, N=227	76.7 7.7%
4 weeks: <80 mm Hg, N=227	58.2 5.8%
8 weeks: <90 mm Hg, N=227	92.1 9.2%
8 weeks: <85 mm Hg, N=227	83.7 8.4%
8 weeks: <80 mm Hg, N=227	71.8 7.2%
12 weeks: <90 mm Hg, N=227	97.4 9.7%
12 weeks: <85 mm Hg, N=227	92.1 9.2%
12 weeks: <80 mm Hg, N=227	80.2 8%
16 weeks: <90 mm Hg, N=227	98.7 9.9%
16 weeks: <85 mm Hg, N=227	94.3 9.4%
16 weeks: <80 mm Hg, N=227	88.6 8.9%
20 weeks: <90 mm Hg, N=227	98.7 9.9%
20 weeks: <85 mm Hg, N=227	95.2 9.5%
20 weeks: <80 mm Hg, N=227	90.3 9%

34. Secondary Outcome

Title	Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	224
4 weeks: ≤ 15 mm Hg, N=224	47.3 4.7%
4 weeks: >15 and ≤ 30 mm Hg, N=224	40.2 4%
4 weeks: >30 and ≤ 45 mm Hg, N=224	11.2 1.1%
4 weeks: >45 mm Hg, N=224	1.3 0.1%
8 weeks: ≤ 15 mm Hg, N=217	42.9 4.3%
8 weeks: >15 and ≤ 30 mm Hg, N=217	37.8 3.8%
8 weeks: >30 and ≤ 45 mm Hg, N=217	16.6 1.7%
8 weeks: >45 mm Hg, N=217	2.8 0.3%
12 weeks: ≤ 15 mm Hg, N=199	26.6 2.7%
12 weeks: >15 and ≤ 30 mm Hg, N=199	46.7 4.7%
12 weeks: >30 and ≤ 45 mm Hg, N=199	24.6 2.5%
12 weeks: >45 mm Hg, N=199	2.0 0.2%
16 weeks: ≤ 15 mm Hg, N=179	17.9 1.8%
16 weeks: >15 and ≤ 30 mm Hg, N=179	32.4 3.2%
16 weeks: >30 and ≤ 45 mm Hg, N=179	39.7 4%
16 weeks: >45 mm Hg, N=179	10.1 1%
20 weeks: ≤ 15 mm Hg, N=166	14.5 1.5%
20 weeks: >15 and ≤ 30 mm Hg, N=166	37.4 3.7%
20 weeks: >30 and ≤ 45 mm Hg, N=166	38.0 3.8%
20 weeks: >45 mm Hg, N=166	10.2 1%

35. Secondary Outcome

Title	Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	224
4 weeks: ≤ 10 mm Hg, N=224	63.8 6.4%
4 weeks: >10 and ≤ 15 mm Hg, N=224	20.5 2.1%
4 weeks: >15 and ≤ 20 mm Hg, N=224	9.4 0.9%
4 weeks: >20 mm Hg, N=224	6.3 0.6%
8 weeks: ≤ 10 mm Hg, N=217	57.1 5.7%
8 weeks: >10 and ≤ 15 mm Hg, N=217	19.8 2%
8 weeks: >15 and ≤ 20 mm Hg, N=217	14.3 1.4%
8 weeks: >20 mm Hg, N=217	8.8 0.9%
12 weeks: ≤ 10 mm Hg, N=199	45.2 4.5%
12 weeks: >10 and ≤15 mm Hg, N=199	25.1 2.5%
12 weeks: >15 and ≤ 20 mm Hg, N=199	15.6 1.6%
12 weeks: >20 mm Hg, N=199	14.1 1.4%
16 weeks: ≤ 10 mm Hg, N=179	27.4 2.7%
16 weeks: >10 and ≤ 15 mm Hg, N=179	25.1 2.5%
16 weeks: >15 and ≤ 20 mm Hg, N=179	22.9 2.3%
16 weeks: >20 mm Hg, N=179	24.6 2.5%
20 weeks: ≤ 10 mm Hg, N=166	34.9 3.5%
20 weeks: >10 and ≤ 15 mm Hg, N=166	20.5 2.1%
20 weeks: >15 and ≤ 20 mm Hg, N=166	24.1 2.4%
20 weeks: >20 mm Hg, N=166	20.5 2.1%

36. Secondary Outcome

Title	Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	190
4 weeks: <140 mm Hg, N=190	54.7 5.5%
4 weeks: <135 mm Hg, N=190	41.1 4.1%
4 weeks: <130 mm Hg, N=190	26.3 2.6%
4 weeks: <120 mm Hg, N=190	10.0 1%
8 weeks: <140 mm Hg, N=190	69.0 6.9%
8 weeks: <135 mm Hg, N=190	56.3 5.6%
8 weeks: <130 mm Hg, N=190	42.6 4.3%
8 weeks: <120 mm Hg, N=190	15.8 1.6%
12 weeks: <140 mm Hg, N=190	81.6 8.2%
12 weeks: <135 mm Hg, N=190	69.5 7%
12 weeks: <130 mm Hg, N=190	57.9 5.8%
12 weeks: <120 mm Hg, N=190	30.0 3%
16 weeks: <140 mm Hg, N=190	87.9 8.8%
16 weeks: <135 mm Hg, N=190	79.0 7.9%
16 weeks: <130 mm Hg, N=190	69.0 6.9%
16 weeks: <120 mm Hg, N=190	39.5 4%
20 weeks: <140 mm Hg, N=190	91.1 9.1%
20 weeks: <135 mm Hg, N=190	84.2 8.4%
20 weeks: <130 mm Hg, N=190	75.3 7.5%
20 weeks: <120 mm Hg, N=190	48.4 4.8%

37. Secondary Outcome

Title	Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	190
4 weeks: <90 mm Hg, N=190	75.8 7.6%
4 weeks: <85 mm Hg, N=190	64.2 6.4%
4 weeks: <80 mm Hg, N=190	39.0 3.9%
8 weeks: <90 mm Hg, N=190	85.8 8.6%
8 weeks: <85 mm Hg, N=190	72.6 7.3%
8 weeks: <80 mm Hg, N=190	51.1 5.1%
12 weeks: <90 mm Hg, N=190	94.2 9.4%
12 weeks: <85 mm Hg, N=190	83.2 8.3%
12 weeks: <80 mm Hg, N=190	63.7 6.4%
16 weeks: <90 mm Hg, N=190	97.9 9.8%
16 weeks: <85 mm Hg, N=190	89.0 8.9%
16 weeks: <80 mm Hg, N=190	70.5 7.1%
20 weeks: <90 mm Hg, N=190	99.0 9.9%
20 weeks: <85 mm Hg, N=190	90.5 9.1%
20 weeks: <80 mm Hg, N=190	76.8 7.7%

38. Secondary Outcome

Title	Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	189
4 weeks: ≤ 15 mm Hg, N=189	56.1 5.6%
4 weeks: >15 and ≤ 30 mm Hg, N=189	36.0 3.6%
4 weeks: >30 and ≤ 45 mm Hg, N=189	7.9 0.8%
4 weeks: >45 mm Hg, N=189	0.0 0%
8 weeks: ≤ 15 mm Hg, N=181	54.1 5.4%
8 weeks: >15 and ≤ 30 mm Hg, N=181	34.3 3.4%
8 weeks: >30 and ≤ 45 mm Hg, N=181	11.6 1.2%
8 weeks: >45 mm Hg, N=181	0.0 0%
12 weeks: ≤ 15 mm Hg, N=170	35.3 3.5%
12 weeks: >15 and ≤ 30 mm Hg, N=170	38.2 3.8%
12 weeks: >30 and ≤ 45 mm Hg, N=170	22.9 2.3%
12 weeks: >45 mm Hg, N=170	3.5 0.4%
16 weeks: ≤ 15 mm Hg, N=156	28.2 2.8%
16 weeks: >15 and ≤ 30 mm Hg, N=156	40.4 4%
16 weeks: >30 and ≤ 45 mm Hg, N=156	26.3 2.6%
16 weeks: >45 mm Hg, N=156	5.1 0.5%
20 weeks: ≤ 15 mm Hg, N=150	26.0 2.6%
20 weeks: >15 and ≤ 30 mm Hg, N=150	40.0 4%
20 weeks: >30 and ≤ 45 mm Hg, N=150	26.7 2.7%
20 weeks: >45 mm Hg, N=150	7.3 0.7%

39. Secondary Outcome

Title	Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	189
4 weeks: ≤ 10 mm Hg, N=189	67.7 6.8%
4 weeks: >10 and ≤ 15 mm Hg, N=189	16.9 1.7%
4 weeks: >15 and ≤ 20 mm Hg, N=189	11.6 1.2%
4 weeks: >20 mm Hg, N=189	3.7 0.4%
8 weeks: ≤ 10 mm Hg, N=181	60.8 6.1%
8 weeks: >10 and ≤ 15 mm Hg, N=181	20.4 2%
8 weeks: >15 and ≤ 20 mm Hg, N=181	14.9 1.5%
8 weeks: >20 mm Hg, N=181	3.9 0.4%
12 weeks: ≤ 10 mm Hg, N=170	41.2 4.1%
12 weeks: >10 and ≤15 mm Hg, N=170	32.4 3.2%
12 weeks: >15 and ≤ 20 mm Hg, N=170	12.9 1.3%
12 weeks: >20 mm Hg, N=170	13.5 1.4%
16 weeks: ≤ 10 mm Hg, N=156	32.7 3.3%
16 weeks: >10 and ≤ 15 mm Hg, N=156	26.9 2.7%
16 weeks: >15 and ≤ 20 mm Hg, N=156	21.8 2.2%
16 weeks: >20 mm Hg, N=156	18.6 1.9%
20 weeks: ≤ 10 mm Hg, N=150	37.3 3.7%
20 weeks: >10 and ≤ 15 mm Hg, N=150	18.0 1.8%
20 weeks: >15 and ≤ 20 mm Hg, N=150	26.0 2.6%
20 weeks: >20 mm Hg, N=150	18.7 1.9%

40. Secondary Outcome

Title	Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	497
4 weeks: <140 mm Hg, N=497	51.3 5.1%
4 weeks: <135 mm Hg, N=497	37.2 3.7%
4 weeks: <130 mm Hg, N=497	23.3 2.3%
4 weeks: <120 mm Hg, N=497	7.9 0.8%
8 weeks: <140 mm Hg, N=500	63.2 6.3%
8 weeks: <135 mm Hg, N=500	49.2 4.9%
8 weeks: <130 mm Hg, N=500	37.0 3.7%
8 weeks: <120 mm Hg, N=500	13.8 1.4%
12 weeks: <140 mm Hg, N=500	76.6 7.7%
12 weeks: <135 mm Hg, N=500	61.6 6.2%
12 weeks: <130 mm Hg, N=500	49.2 4.9%
12 weeks: <120 mm Hg, N=500	23.2 2.3%
16 weeks: <140 mm Hg, N=500	85.8 8.6%
16 weeks: <135 mm Hg, N=500	75.6 7.6%
16 weeks: <130 mm Hg, N=500	63.6 6.4%
16 weeks: <120 mm Hg, N=500	34.6 3.5%
20 weeks: <140 mm Hg, N=500	90.2 9%
20 weeks: <135 mm Hg, N=500	82.6 8.3%
20 weeks: <130 mm Hg, N=500	72.2 7.2%
20 weeks: <120 mm Hg, N=500	43.0 4.3%

41. Secondary Outcome

Title	Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	497
4 weeks: <90 mm Hg, N=497	63.2 6.3%
4 weeks: <85 mm Hg, N=497	46.3 4.6%
4 weeks: <80 mm Hg, N=497	26.0 2.6%
8 weeks: <90 mm Hg, N=497	77.2 7.7%
8 weeks: <85 mm Hg, N=500	59.4 5.9%
8 weeks: <80 mm Hg, N=500	38.8 3.9%
12 weeks: <90 mm Hg, N=500	86.6 8.7%
12 weeks: <85 mm Hg, N=500	69.8 7%
12 weeks: <80 mm Hg, N=500	48.4 4.8%
16 weeks: <90 mm Hg, N=500	93.2 9.3%
16 weeks: <85 mm Hg, N=500	80.4 8%
16 weeks: <80 mm Hg, N=500	60.4 6%
20 weeks: <90 mm Hg, N=500	94.6 9.5%
20 weeks: <85 mm Hg, N=500	83.8 8.4%
20 weeks: <80 mm Hg, N=500	67.6 6.8%

42. Secondary Outcome

Title	Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	495
4 weeks: ≤ 15 mm Hg, N=495	56.0 5.6%
4 weeks: >15 and ≤ 30 mm Hg, N=495	35.2 3.5%
4 weeks: >30 and ≤ 45 mm Hg, N=495	8.5 0.9%
4 weeks: >45 mm Hg, N=495	0.4 0%
8 weeks: ≤ 15 mm Hg, N=468	52.4 5.2%
8 weeks: >15 and ≤ 30 mm Hg, N=468	35.9 3.6%
8 weeks: >30 and ≤ 45 mm Hg, N=468	10.3 1%
8 weeks: >45 mm Hg, N=468	1.5 0.2%
12 weeks: ≤ 15 mm Hg, N=436	37.8 3.8%
12 weeks: >15 and ≤ 30 mm Hg, N=436	42.4 4.2%
12 weeks: >30 and ≤ 45 mm Hg, N=436	17.4 1.7%
12 weeks: >45 mm Hg, N=436	2.5 0.3%
16 weeks: ≤ 15 mm Hg, N=400	27.8 2.8%
16 weeks: >15 and ≤ 30 mm Hg, N=400	36.0 3.6%
16 weeks: >30 and ≤ 45 mm Hg, N=400	27.5 2.8%
16 weeks: >45 mm Hg, N=400	8.8 0.9%
20 weeks: ≤ 15 mm Hg, N=379	20.6 2.1%
20 weeks: >15 and ≤ 30 mm Hg, N=379	37.5 3.8%
20 weeks: >30 and ≤ 45 mm Hg, N=379	33.3 3.3%
20 weeks: >45 mm Hg, N=379	8.7 0.9%

43. Secondary Outcome

Title	Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	495
4 weeks: ≤ 10 mm Hg, N=495	67.5 6.8%
4 weeks: >10 and ≤ 15 mm Hg, N=495	17.8 1.8%
4 weeks: >15 and ≤ 20 mm Hg, N=495	8.5 0.9%
4 weeks: >20 mm Hg, N=495	6.3 0.6%
8 weeks: ≤ 10 mm Hg, N=468	59.4 5.9%
8 weeks: >10 and ≤ 15 mm Hg, N=468	19.9 2%
8 weeks: >15 and ≤ 20 mm Hg, N=468	13.0 1.3%
8 weeks: >20 mm Hg, N=468	7.7 0.8%
12 weeks: ≤ 10 mm Hg, N=436	48.9 4.9%
12 weeks: >10 and ≤15 mm Hg, N=436	22.5 2.3%
12 weeks: >15 and ≤ 20 mm Hg, N=436	16.1 1.6%
12 weeks: >20 mm Hg, N=436	12.6 1.3%
16 weeks: ≤ 10 mm Hg, N=400	33.3 3.3%
16 weeks: >10 and ≤ 15 mm Hg, N=400	23.0 2.3%
16 weeks: >15 and ≤ 20 mm Hg, N=400	19.0 1.9%
16 weeks: >20 mm Hg, N=400	24.8 2.5%
20 weeks: ≤ 10 mm Hg, N=379	31.9 3.2%
20 weeks: >10 and ≤ 15 mm Hg, N=379	18.7 1.9%
20 weeks: >15 and ≤ 20 mm Hg, N=379	22.4 2.2%
20 weeks: >20 mm Hg, N=379	26.9 2.7%

44. Secondary Outcome

Title	Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	454
4 weeks: <140 mm Hg, N=454	56.4 5.6%
4 weeks: <135 mm Hg, N=454	41.4 4.1%
4 weeks: <130 mm Hg, N=454	27.1 2.7%
4 weeks: <120 mm Hg, N=454	7.9 0.8%
8 weeks: <140 mm Hg, N=457	67.6 6.8%
8 weeks: <135 mm Hg, N=457	54.3 5.4%
8 weeks: <130 mm Hg, N=457	40.9 4.1%
8 weeks: <120 mm Hg, N=457	16.2 1.6%
12 weeks: <140 mm Hg, N=457	81.4 8.1%
12 weeks: <135 mm Hg, N=457	67.2 6.7%
12 weeks: <130 mm Hg, N=457	54.1 5.4%
12 weeks: <120 mm Hg, N=457	27.6 2.8%
16 weeks: <140 mm Hg, N=457	88.8 8.9%
16 weeks: <135 mm Hg, N=457	80.3 8%
16 weeks: <130 mm Hg, N=457	67.0 6.7%
16 weeks: <120 mm Hg, N=457	39.0 3.9%
20 weeks: <140 mm Hg, N=457	91.5 9.2%
20 weeks: <135 mm Hg, N=457	85.6 8.6%
20 weeks: <130 mm Hg, N=457	74.8 7.5%
20 weeks: <120 mm Hg, N=457	47.1 4.7%

45. Secondary Outcome

Title	Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	454
4 weeks: <90 mm Hg, N=454	69.6 7%
4 weeks: <85 mm Hg, N=454	53.5 5.4%
4 weeks: <80 mm Hg, N=454	31.9 3.2%
8 weeks: <90 mm Hg, N=457	82.1 8.2%
8 weeks: <85 mm Hg, N=457	66.1 6.6%
8 weeks: <80 mm Hg, N=457	43.5 4.4%
12 weeks: <90 mm Hg, N=457	90.4 9%
12 weeks: <85 mm Hg, N=457	76.6 7.7%
12 weeks: <80 mm Hg, N=457	56.5 5.7%
16 weeks: <90 mm Hg, N=457	94.8 9.5%
16 weeks: <85 mm Hg, N=457	83.2 8.3%
16 weeks: <80 mm Hg, N=457	65.9 6.6%
20 weeks: <90 mm Hg, N=457	95.4 9.5%
20 weeks: <85 mm Hg, N=457	86.2 8.6%
20 weeks: <80 mm Hg, N=457	72.0 7.2%

46. Secondary Outcome

Title	Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	453
4 weeks: ≤ 15 mm Hg, N=453	49.5 5%
4 weeks: >15 and ≤ 30 mm Hg, N=453	38.4 3.8%
4 weeks: >30 and ≤ 45 mm Hg, N=453	11.5 1.2%
4 weeks: >45 mm Hg, N=453	0.7 0.1%
8 weeks: ≤ 15 mm Hg, N=431	48.0 4.8%
8 weeks: >15 and ≤ 30 mm Hg, N=431	35.5 3.6%
8 weeks: >30 and ≤ 45 mm Hg, N=431	14.4 1.4%
8 weeks: >45 mm Hg, N=431	2.1 0.2%
12 weeks: ≤ 15 mm Hg, N=402	30.4 3%
12 weeks: >15 and ≤ 30 mm Hg, N=402	43.8 4.4%
12 weeks: >30 and ≤ 45 mm Hg, N=402	22.6 2.3%
12 weeks: >45 mm Hg, N=402	3.2 0.3%
16 weeks: ≤ 15 mm Hg, N=371	24.0 2.4%
16 weeks: >15 and ≤ 30 mm Hg, N=371	37.7 3.8%
16 weeks: >30 and ≤ 45 mm Hg, N=371	29.1 2.9%
16 weeks: >45 mm Hg, N=371	9.2 0.9%
20 weeks: ≤ 15 mm Hg, N=356	19.7 2%
20 weeks: >15 and ≤ 30 mm Hg, N=356	36.5 3.7%
20 weeks: >30 and ≤ 45 mm Hg, N=356	36.0 3.6%
20 weeks: >45 mm Hg, N=356	7.9 0.8%

47. Secondary Outcome

Title	Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
Time Frame	Baseline to 4, 8, 12, 16, 20 weeks

Outcome Measure Data

Analysis Population Description

Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	453
4 weeks: ≤ 10 mm Hg, N=453	62.7 6.3%
4 weeks: >10 and ≤ 15 mm Hg, N=453	22.3 2.2%
4 weeks: >15 and ≤ 20 mm Hg, N=453	8.6 0.9%
4 weeks: >20 mm Hg, N=453	6.4 0.6%
8 weeks: ≤ 10 mm Hg, N=431	56.6 5.7%
8 weeks: >10 and ≤ 15 mm Hg, N=431	19.7 2%
8 weeks: >15 and ≤ 20 mm Hg, N=431	15.3 1.5%
8 weeks: >20 mm Hg, N=431	8.4 0.8%
12 weeks: ≤ 10 mm Hg, N=402	44.3 4.4%
12 weeks: >10 and ≤15 mm Hg, N=402	22.1 2.2%
12 weeks: >15 and ≤ 20 mm Hg, N=402	17.4 1.7%
12 weeks: >20 mm Hg, N=402	16.2 1.6%
16 weeks: ≤ 10 mm Hg, N=371	32.4 3.2%
16 weeks: >10 and ≤ 15 mm Hg, N=371	24.0 2.4%
16 weeks: >15 and ≤ 20 mm Hg, N=371	21.0 2.1%
16 weeks: >20 mm Hg, N=371	22.6 2.3%
20 weeks: ≤ 10 mm Hg, N=356	33.2 3.3%
20 weeks: >10 and ≤ 15 mm Hg, N=356	19.4 1.9%
20 weeks: >15 and ≤ 20 mm Hg, N=356	22.5 2.3%
20 weeks: >20 mm Hg, N=356	25.0 2.5%

48. Secondary Outcome

Title	Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Participants previously on a Dihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	117
Systolic blood pressure <140 mmHg	73.5 7.4%
Systolic blood pressure <135 mmHg	59.0 5.9%
Systolic blood pressure <130 mmHg	47.9 4.8%
Systolic blood pressure <120 mmHg	18.8 1.9%
Diastolic blood pressure <90 mmHg	86.3 8.6%
Diastolic blood pressure <85 mmHg	72.7 7.3%
Diastolic blood pressure <80 mmHg	48.7 4.9%
Blood pressure <140/90 mmHg	68.4 6.8%
Blood pressure <135/80 mmHg	40.2 4%
Blood pressure <130/80 mmHg	34.2 3.4%
Blood pressure <120/80 mmHg	16.2 1.6%

49. Secondary Outcome

Title	Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks
Time Frame	Baseline to 20 weeks

Outcome Measure Data

Analysis Population Description

Participants previously on a Dihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	117
Systolic blood pressure <140 mmHg	89.7 9%
Systolic blood pressure <135 mmHg	83.8 8.4%
Systolic blood pressure <130 mmHg	69.2 6.9%
Systolic blood pressure <120 mmHg	41.0 4.1%
Diastolic blood pressure <90 mmHg	91.5 9.2%
Diastolic blood pressure <85 mmHg	85.5 8.6%
Diastolic blood pressure <80 mmHg	69.2 6.9%
Blood pressure <140/90 mmHg	85.5 8.6%
Blood pressure <135/80 mmHg	64.1 6.4%
Blood pressure <130/80 mmHg	59.8 6%
Blood pressure <120/80 mmHg	36.8 3.7%

50. Secondary Outcome

Title	Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Participants previously on a diuretic who have received at least one dose of study medication and who have a baseline value.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	166
Systolic blood pressure <140 mmHg	92.8 9.3%
Systolic blood pressure <135 mmHg	82.5 8.3%
Systolic blood pressure <130 mmHg	78.3 7.8%
Systolic blood pressure <120 mmHg	51.2 5.1%
Diastolic blood pressure <90 mmHg	94.6 9.5%
Diastolic blood pressure <85 mmHg	86.8 8.7%
Diastolic blood pressure <80 mmHg	71.7 7.2%
Blood pressure <140/90 mmHg	88.6 8.9%
Blood pressure <135/80 mmHg	67.5 6.8%
Blood pressure <130/80 mmHg	65.1 6.5%
Blood pressure <120/80 mmHg	48.2 4.8%

51. Secondary Outcome

Title	Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks
Time Frame	Baseline to 20 weeks

Outcome Measure Data

Analysis Population Description

Participants previously on a diuretic who have received at least one dose of study medication and who have a baseline value.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	166
Systolic blood pressure <140 mmHg	92.8 9.3%
Systolic blood pressure <135 mmHg	82.5 8.3%
Systolic blood pressure <130 mmHg	78.3 7.8%
Systolic blood pressure <120 mmHg	51.2 5.1%
Diastolic blood pressure <90 mmHg	94.6 9.5%
Diastolic blood pressure <85 mmHg	86.8 8.7%
Diastolic blood pressure <80 mmHg	71.7 7.2%
Blood pressure <140/90 mmHg	88.6 8.9%
Blood pressure <135/80 mmHg	67.5 6.8%
Blood pressure <130/80 mmHg	65.1 6.5%
Blood pressure <120/80 mmHg	48.2 4.8%

52. Secondary Outcome

Title	Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Participants previously on an angiotensin converting enzyme inhibitor who have received at least one dose of study medication and who have a baseline value.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	283
Systolic blood pressure <140 mmHg	81.3 8.1%
Systolic blood pressure <135 mmHg	69.3 6.9%
Systolic blood pressure <130 mmHg	53.0 5.3%
Systolic blood pressure <120 mmHg	31.5 3.2%
Diastolic blood pressure <90 mmHg	94.4 9.4%
Diastolic blood pressure <85 mmHg	80.6 8.1%
Diastolic blood pressure <80 mmHg	64.3 6.4%
Blood pressure <140/90 mmHg	78.5 7.9%
Blood pressure <135/80 mmHg	52.7 5.3%
Blood pressure <130/80 mmHg	43.5 4.4%
Blood pressure <120/80 mmHg	27.9 2.8%

53. Secondary Outcome

Title	Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks
Time Frame	Baseline to 20 weeks

Outcome Measure Data

Analysis Population Description

Participants previously on an angiotensin converting enzyme inhibitor who have received at least one dose of study medication and who have a baseline value.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	283
Systolic blood pressure <140 mmHg	91.5 9.2%
Systolic blood pressure <135 mmHg	84.5 8.5%
Systolic blood pressure <130 mmHg	71.4 7.1%
Systolic blood pressure <120 mmHg	47.4 4.7%
Diastolic blood pressure <90 mmHg	98.2 9.8%
Diastolic blood pressure <85 mmHg	89.8 9%
Diastolic blood pressure <80 mmHg	78.5 7.9%
Blood pressure <140/90 mmHg	90.5 9.1%
Blood pressure <135/80 mmHg	71.0 7.1%
Blood pressure <130/80 mmHg	61.5 6.2%
Blood pressure <120/80 mmHg	44.5 4.5%

54. Secondary Outcome

Title	Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Participants previously on an angiotensin II receptor blocker who have received at least one dose of study medication and who have a baseline value.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	234
Systolic blood pressure <140 mmHg	80.8 8.1%
Systolic blood pressure <135 mmHg	69.2 6.9%
Systolic blood pressure <130 mmHg	56.0 5.6%
Systolic blood pressure <120 mmHg	26.1 2.6%
Diastolic blood pressure <90 mmHg	89.7 9%
Diastolic blood pressure <85 mmHg	76.9 7.7%
Diastolic blood pressure <80 mmHg	59.0 5.9%
Blood pressure <140/90 mmHg	76.1 7.6%
Blood pressure <135/80 mmHg	52.6 5.3%
Blood pressure <130/80 mmHg	46.2 4.6%
Blood pressure <120/80 mmHg	23.1 2.3%

55. Secondary Outcome

Title	Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks
Time Frame	Baseline to 20 weeks

Outcome Measure Data

Analysis Population Description

Participants previously on an angiotensin II receptor blocker who have received at least one dose of study medication and who have a baseline value.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	234
Systolic blood pressure <140 mmHg	92.3 9.2%
Systolic blood pressure <135 mmHg	87.2 8.7%
Systolic blood pressure <130 mmHg	79.5 8%
Systolic blood pressure <120 mmHg	47.4 4.7%
Diastolic blood pressure <90 mmHg	96.6 9.7%
Diastolic blood pressure <85 mmHg	89.3 8.9%
Diastolic blood pressure <80 mmHg	74.8 7.5%
Blood pressure <140/90 mmHg	90.6 9.1%
Blood pressure <135/80 mmHg	70.1 7%
Blood pressure <130/80 mmHg	65.0 6.5%
Blood pressure <120/80 mmHg	44.0 4.4%

56. Secondary Outcome

Title	Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Participants previously on an beta blocker who have received at least one dose of study medication and who have a baseline value.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	113
Systolic blood pressure <140 mmHg	88.5 8.9%
Systolic blood pressure <135 mmHg	75.2 7.5%
Systolic blood pressure <130 mmHg	62.0 6.2%
Systolic blood pressure <120 mmHg	33.6 3.4%
Diastolic blood pressure <90 mmHg	94.7 9.5%
Diastolic blood pressure <85 mmHg	83.2 8.3%
Diastolic blood pressure <80 mmHg	61.1 6.1%
Blood pressure <140/90 mmHg	86.7 8.7%
Blood pressure <135/80 mmHg	55.8 5.6%
Blood pressure <130/80 mmHg	49.6 5%
Blood pressure <120/80 mmHg	29.2 2.9%

57. Secondary Outcome

Title	Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks
Time Frame	Baseline to 20 weeks

Outcome Measure Data

Analysis Population Description

Participants previously on an beta blocker who have received at least one dose of study medication and who have a baseline value.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	113
Systolic blood pressure <140 mmHg	93.8 9.4%
Systolic blood pressure <135 mmHg	87.6 8.8%
Systolic blood pressure <130 mmHg	79.7 8%
Systolic blood pressure <120 mmHg	47.8 4.8%
Diastolic blood pressure <90 mmHg	98.2 9.8%
Diastolic blood pressure <85 mmHg	89.4 8.9%
Diastolic blood pressure <80 mmHg	77.0 7.7%
Blood pressure <140/90 mmHg	92.9 9.3%
Blood pressure <135/80 mmHg	74.3 7.4%
Blood pressure <130/80 mmHg	69.9 7%
Blood pressure <120/80 mmHg	43.4 4.3%

58. Secondary Outcome

Title	Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Participants previously on a Nondihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	20
Systolic blood pressure <140 mmHg	100.0 10%
Systolic blood pressure <135 mmHg	90.0 9%
Systolic blood pressure <130 mmHg	75.0 7.5%
Systolic blood pressure <120 mmHg	25.0 2.5%
Diastolic blood pressure <90 mmHg	100.0 10%
Diastolic blood pressure <85 mmHg	95.0 9.5%
Diastolic blood pressure <80 mmHg	75.0 7.5%
Blood pressure <140/90 mmHg	100.0 10%
Blood pressure <135/80 mmHg	70.0 7%
Blood pressure <130/80 mmHg	65.0 6.5%
Blood pressure <120/80 mmHg	20.0 2%

59. Secondary Outcome

Title	Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks
Time Frame	Baseline to 20 weeks

Outcome Measure Data

Analysis Population Description

Participants previously on a Nondihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.

Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Measure Participants	20
Systolic blood pressure <140 mmHg	100.0 10%
Systolic blood pressure <135 mmHg	100.0 10%
Systolic blood pressure <130 mmHg	95.0 9.5%
Systolic blood pressure <120 mmHg	45.0 4.5%
Diastolic blood pressure <90 mmHg	100.0 10%
Diastolic blood pressure <85 mmHg	95.0 9.5%
Diastolic blood pressure <80 mmHg	95.0 9.5%
Blood pressure <140/90 mmHg	100.0 10%
Blood pressure <135/80 mmHg	95.0 9.5%
Blood pressure <130/80 mmHg	95.0 9.5%
Blood pressure <120/80 mmHg	40.0 4%

Adverse Events

Time Frame	Adverse events were collected for the 20-week treatment period + a 2-week post-treatment follow-up, plus an additional 30 days after last dose.
Adverse Event Reporting Description	AE's were either observed by the investigator via physical examinations and laboratory testing and/or reported by the subject.
Arm/Group Title	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
Arm/Group Description	Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
All Cause Mortality
	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Affected / at Risk (%)	# Events
Total	13/999 (1.3%)
Cardiac disorders
myocardial infarction	2/999 (0.2%)	2
Gastrointestinal disorders
oesophageal rupture	1/999 (0.1%)	1
abdominal pain	1/999 (0.1%)	1
Injury, poisoning and procedural complications
road traffic accident	1/999 (0.1%)	1
Musculoskeletal and connective tissue disorders
muscular weakness	1/999 (0.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non small cell lung cancer	1/999 (0.1%)	1
protate cancer	1/999 (0.1%)	1
Nervous system disorders
presyncope	1/999 (0.1%)	1
epilepsy	1/999 (0.1%)	1
Psychiatric disorders
depession	1/999 (0.1%)	1
Reproductive system and breast disorders
vaginal haemhorrage	1/999 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
asthma	1/999 (0.1%)	1
Other (Not Including Serious) Adverse Events
	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide
	Affected / at Risk (%)	# Events
Total	241/999 (24.1%)
General disorders
oedema	86/999 (8.6%)
Nervous system disorders
headache	52/999 (5.2%)
dizziness	103/999 (10.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

As stated in the clinical study agreement, If identified by DSI, any of DSI's confidential information as defined herein shall be deleted...Nothing in this publication section shall be taken as giving DSI any right of editorial control over any publicartion prepared by the Study Site."