18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics

• Sponsor: Daiichi Sankyo, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00654745
• Collaborator: (none)
• Enrollment: 207
• Locations: 21
• Arm: 1
• Duration (Months): 13
• Patients Per Site: 9.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

To determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes; Hypertension	Drug: Amlodipine; Drug: amlodipine / olmesartan medoxomil combination; Drug: Hydrochlorothiazide	Phase 4

Detailed Description

This is a single group study in which participants were titrated to the next of 6 regimens if blood pressure (BP) goals were not met.

Study Design

• Study Type: Interventional
• Actual Enrollment: 207 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Open-label, Ambulatory Blood Pressure Monitoring (ABPM) Dose Titration Study to Evaluate the Safety and Efficacy of an Olmesartan Medoxomil and Amlodipine Based Treatment Regimen in Hypertensive, Type 2 Diabetic Subjects
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: aml + olm + hctz amlodipine; and olmesartan medoxomil, if required; and hydrochlorothiazide, if required.	Drug: Amlodipine; Amlodipine 5 mg tablets , Daily for 3 weeks; Other Names: Norvasc ; Drug: amlodipine / olmesartan medoxomil combination; amlodipine / olmesartan medoxomil combination tablets 5 mg/20 mg or 5 mg/40 mg or 10 mg/40 mg; Other Names: Azor ; Drug: Hydrochlorothiazide; hydrochlorothiazide tablets, 12.5 mg or 25 mg.

Outcome Measures

Primary Outcome Measures

1. Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment [week 0 - week 12]

   Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0.

Secondary Outcome Measures

1. Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment [week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)]

   24-hour mean DBP, Daytime mean DBP, Nighttime mean DBP, Last 6 hour mean DBP, Last 4 hour mean DBP, Last 2 hour mean DBP

2. Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment [week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)]

   Daytime mean SBP, Nighttime mean SBP, Last 6 hour mean SBP, Last 4 hour mean SBP, Last 2 hour mean SBP

3. Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks [week 0 - weeks 3, 6, 9, 12, 15, 18]

   change in mean SeSBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.

4. Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks [week 0 - weeks 3, 6, 9, 12, 15, 18]

   change in mean SeDBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.

5. Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12 [week 0 - week 12]

   number of participants achieving mean 24-hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12

6. Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12 [week 0 - week 12]

   number of participants achieving mean daytime ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12

7. Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12 [week 0 - week 12]

   number of participants achieving mean nighttime ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, BP<120/70, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75, DBP<70 at week 12

8. Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12 [week 0 - week 12]

   number participants achieving mean last 6 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12

9. Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12 [week 0 - week 12]

   number of participants achieving mean last 4 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12

10. Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12 [week 0 - week 12]

    number of participants achieving mean last 2 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12

11. Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3 [week 0 - week 3]

    number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 3

12. Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6 [week 0 - week 6]

    number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 6

13. Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9 [week 0 - week 9]

    number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 9

14. Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12 [week 0 - week 12]

    number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12

15. Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15 [week 0 - week 15]

    number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 15

16. Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18 [week 0 - week 18]

    number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 18

17. Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 [week 0 - week 12]

    number of participants achieving mean 24 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12

18. Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 [week 0 - week 12]

    number of participants achieving mean daytime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12

19. Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 [week 0 - week 12]

    number of participants achieving mean nighttime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12

20. Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 [week 0 - week 12]

    number of participants achieving mean last 6 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12

21. Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions [week 0 - week 12]

    number of participants achieving mean last 4 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12

22. Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 [week 0 - week 12]

    number of participants achieving mean last 2 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12

23. Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3 [week 0 - week 3]

    number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 3

24. Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6 [week 0 - week 6]

    number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 6

25. Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9 [week 0 - week 9]

    number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 9

26. Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12 [week 0 - week 12]

    number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12

27. Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15 [week 0 - week 15]

    number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 15

28. Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18 [week 0 - week 18]

    number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 18

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males or females aged 18 to 80 years.

• Diagnosis of type 2 diabetes mellitus and on a stable regimen of any oral antidiabetic agent(s) for at least 3 months, with or without adjunctive use of Byetta (exenatide);

Note: Subjects diagnosed with type 2 diabetes mellitus who were not on oral antidiabetic agents may have been enrolled if they had a documented history of type 2 diabetes by American Diabetes Association criteria, including the specific plasma glucose results listed below:

• Fasting plasma glucose >=126 mg/dL (7.0 mmol/L); or

• Symptoms of hyperglycemia and a casual (any time of day without regard to time since last meal) plasma glucose >=200 mg/dL (11.1 mmol/L). The classic symptoms of hyperglycemia were considered to include polyuria, polydipsia, and unexplained weight loss; or

• Two-hour plasma glucose >=200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test;

• Newly diagnosed hypertension or uncontrolled hypertension (defined as SBP >130 mmHg and/or DBP >80 mmHg) on current antihypertensive monotherapy or combination therapy.

• Subjects must fulfill mean seated office blood pressure parameters at two consecutive, qualifying visits during the placebo run-in phase, and, subsequently, daytime ambulatory blood pressure monitoring (ABPM) criteria.

• Females should not be pregnant or lactating and, if applicable, using adequate contraception.

Exclusion Criteria:

• Subjects with uncontrolled hypertension taking multiple antihypertensive therapies (at the discretion of the investigator).

• Type 2 diabetes mellitus with a glycosylated hemoglobin A1c (HbA1c) >=9.0% at screening;

• Subjects with type 1 or type 2 diabetes mellitus requiring insulin.

• Subjects with any serious disorder which may limit the ability to evaluate the safety and efficacy of study medication, or subjects with secondary hypertension.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Los Angeles	California	United States
2		Sylmar	California	United States
3		Tustin	California	United States
4		Aventura	Florida	United States
5		DeLand	Florida	United States
6		Hialeah	Florida	United States
7		Pembroke Pines	Florida	United States
8		Avon	Indiana	United States
9		Indianapolis	Indiana	United States
10		Las Vegas	Nevada	United States
11		New Windsor	New York	United States
12		Winston-Salem	North Carolina	United States
13		Cincinnati	Ohio	United States
14		Oklahoma City	Oklahoma	United States
15		Charleston	South Carolina	United States
16		Greer	South Carolina	United States
17		Taylors	South Carolina	United States
18		Nashville	Tennessee	United States
19		Dallas	Texas	United States
20		San Antonio	Texas	United States
21		Burke	Virginia	United States

Sponsors and Collaborators

• Daiichi Sankyo, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00654745
• Other Study ID Numbers: CS-8663-403
• First Posted: Apr 9, 2008
• Last Update Posted: Jul 13, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: blood pressure reduction
• Additional relevant MeSH terms: Hypertension; Amlodipine; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil

Study Results

Participant Flow

Recruitment Details	Subjects were recruited at 32 sites in the USA from May 12, 2008 to Jan 2, 2009 and 207 enrolled into the active treatment period. The study population consisted of subjects with controlled type 2 diabetes, not requiring insulin therapy, whose hypertension was newly diagnosed or uncontrolled on antihypertensive monotherapy or combination therapy.
Pre-assignment Detail	Subjects began washout of anti-hypertensive medications during screening then entered placebo run-in lasting 2-3 weeks. Subjects must meet seated blood pressure (BP) criteria at 2 consecutive qualifying visits during the run-in period and satisfy mean daytime ambulatory BP criteria at baseline, one day prior to the first dose of active study drug.

Arm/Group Title	Amlodipine, Olmesartan Medoxomil, Hydrochlorothiazide
Arm/Group Description	Participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Period Title: Overall Study
STARTED	207
COMPLETED	164
NOT COMPLETED	43

Baseline Characteristics

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine (aml) + olmesartan medoxomil (olm)+ hhdrochlorothiazide (hctz) is total number enrolled. Each group is the number of participants that were titrated to that dosing regimen as per the protocol. The total number of participants of the individual groups does not (and should not) equal the total number enrolled.
Overall Participants	207
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.1 (9.50)
Sex: Female, Male (Count of Participants)
Female	122 58.9%
Male	85 41.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	54 26.1%
Not Hispanic or Latino	153 73.9%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.5%
Asian	8 3.9%
Native Hawaiian or Other Pacific Islander	1 0.5%
Black or African American	35 16.9%
White	162 78.3%
More than one race	0 0%
Unknown or Not Reported	0 0%
Stage of hypertension (participants) [Number]
Stage 1	115 55.6%
Stage 2	92 44.4%
Body mass index (mg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/m2]	32.80 (5.947)
Mean 24-hour ambulatory diastolic blood pressure (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	81.6 (9.76)
Mean 24-hour ambulatory systolic blood pressure (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	144.4 (11.74)
Pulse rate (beats per minute) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [beats per minute]	73.75 (11.909)
Seated Diastolic Blood Pressure (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	89.1 (10.13)
Seated Systolic Blood Pressure (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	158.8 (13.14)
Years with diabetes (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	6.44 (5.978)

Outcome Measures

1. Primary Outcome

Title	Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment
Description	Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0.
Time Frame	week 0 - week 12

Outcome Measure Data

Analysis Population Description

ABPM subjects analysis population included 165 subjects who received at least one dose of active study medication and provided valid ambulatory blood pressure monitoring measurements at baseline and week 12.

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	165
Mean (Standard Error) [mm Hg]	-19.9 (0.76)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-19.9
	Confidence Interval	(2-Sided) 95%; -21.5 to -18.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment
Description	24-hour mean DBP, Daytime mean DBP, Nighttime mean DBP, Last 6 hour mean DBP, Last 4 hour mean DBP, Last 2 hour mean DBP
Time Frame	week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	165
24-hour mean DBP change from baseline	-11.2 (0.50)
daytime mean DBP change from baseline	-11.7 (0.60)
nighttime mean DBP change from baseline	-10.4 (0.68)
last 6 hour mean DBP change from baseline	-10.9 (0.64)
last 4 hour mean DBP change from baseline	-11.1 (0.68)
last 2 hour mean DBP change from baseline	-11.5 (0.76)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	24-hour mean DBP change from baseline to week 12.
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-11.2
	Confidence Interval	(2-Sided) 95%; -12.2 to -10.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	daytime mean DBP change from baseline to week 12.
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-11.7
	Confidence Interval	(2-Sided) 95%; -12.9 to -10.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	nighttime mean DBP change from baseline to week 12.
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-10.4
	Confidence Interval	(2-Sided) 95%; -11.7 to -9.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	last 6 hours mean DBP change from baseline to week 12.
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-10.9
	Confidence Interval	(2-Sided) 95%; -12.2 to -9.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	last 4 hours mean DBP change from baseline to week 12.
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
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 6

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	last 2 hours mean DBP change from baseline to week 12.
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-11.5
	Confidence Interval	(2-Sided) 95%; -13.1 to -10.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment
Description	Daytime mean SBP, Nighttime mean SBP, Last 6 hour mean SBP, Last 4 hour mean SBP, Last 2 hour mean SBP
Time Frame	week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	165
daytime mean SBP change from baseline	-20.8 (0.92)
nighttime mean SBP change from baseline	-18.5 (0.95)
last 6 hours mean SBP change from baseline	-18.9 (0.93)
last 4 hours mean SBP change from baseline	-19.1 (1.02)
last 2 hours mean SBP change from baseline	-19.5 (1.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	daytime mean SBP change from baseline to week 12.
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-20.8
	Confidence Interval	(2-Sided) 95%; -22.6 to -18.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	nighttime mean SBP change from baseline to week 12.
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-18.5
	Confidence Interval	(2-Sided) 95%; -20.4 to -16.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	last 6 hours mean SBP change from baseline to week 12.
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-18.9
	Confidence Interval	(2-Sided) 95%; -20.7 to -17.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	last 4 hours mean SBP change from baseline to week 12.
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-19.1
	Confidence Interval	(2-Sided) 95%; -21.1 to -17.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	last 2 hours mean SBP change from baseline to week 12.
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-19.5
	Confidence Interval	(2-Sided) 95%; -21.7 to -17.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
Description	change in mean SeSBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.
Time Frame	week 0 - weeks 3, 6, 9, 12, 15, 18

Outcome Measure Data

Analysis Population Description

Number of participants changed by week. Week 3 = 201, Week 6 = 192, week 9 = 184, week 12 = 177, week 15 = 172, week 18 = 164.

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	201
week 3 mean SBP change from baseline	-10.3 (0.87)
week 6 mean SBP change from baseline	-17.9 (0.92)
week 9 mean SBP change from baseline	-20.0 (1.10)
week 12 mean SBP change from baseline	-23.7 (1.02)
week 15 mean SBP change from baseline	-28.5 (1.16)
week 18 mean SBP change from baseline	-31.1 (1.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Change in mean seated systolic blood pressure from baseline to week 3.
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-10.3
	Confidence Interval	(2-Sided) 95%; -12.0 to -8.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Change in mean seated systolic blood pressure from baseline to week 6.
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-17.9
	Confidence Interval	(2-Sided) 95%; -19.8 to -16.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Change in mean seated systolic blood pressure from baseline to week 9
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-20.0
	Confidence Interval	(2-Sided) 95%; -22.2 to -17.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Change in mean seated systolic blood pressure from baseline to week 12
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-23.7
	Confidence Interval	(2-Sided) 95%; -25.7 to -21.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Change in mean seated systolic blood pressure from baseline to week 15
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-28.5
	Confidence Interval	(2-Sided) 95%; -30.8 to -26.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Change in mean seated systolic blood pressure from baseline to week 18
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-31.1
	Confidence Interval	(2-Sided) 95%; -33.3 to -28.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
Description	change in mean SeDBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.
Time Frame	week 0 - weeks 3, 6, 9, 12, 15, 18

Outcome Measure Data

Analysis Population Description

Number of participants changed by week. Week 3 = 201, Week 6 = 192, week 9 = 184, week 12 = 177, week 15 = 172, week 18 = 164.

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	201
week 3 mean seDBP change from baseline	-4.1 (0.50)
week 6 mean seDBP change from baseline	-8.2 (0.60)
week 9 mean seDBP change from baseline	-9.7 (0.64)
week 12 mean seDBP change from baseline	-11.2 (0.64)
week 15 mean seDBP change from baseline	-14.4 (0.66)
week 18 mean seDBP change from baseline	-15.1 (0.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Change in mean seated diastolic blood pressure from baseline to week 3.
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.1
	Confidence Interval	(2-Sided) 95%; -5.1 to -3.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Change in mean seated diastolic blood pressure from baseline to week 6
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.2
	Confidence Interval	(2-Sided) 95%; -9.4 to -7.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Change in mean seated diastolic blood pressure from baseline to week 9
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-9.7
	Confidence Interval	(2-Sided) 95%; -10.9 to -8.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Change in mean seated diastolic blood pressure from baseline to week 12
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-11.2
	Confidence Interval	(2-Sided) 95%; -12.5 to -9.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Change in mean seated diastolic blood pressure from baseline to week 15
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-14.4
	Confidence Interval	(2-Sided) 95%; -15.7 to -13.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Aml + Olm + Hctz
	Comments	Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Change in mean seated diastolic blood pressure from baseline to week 18
	Method	t-test, 2 sided
	Comments	standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-15.1
	Confidence Interval	(2-Sided) 95%; -16.5 to -13.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12
Description	number of participants achieving mean 24-hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12
Time Frame	week 0 - week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	165
mean 24-hour BP <135/85	140 67.6%
mean 24-hour BP <130/80	116 56%
mean 24-hour BP <125/75	76 36.7%
mean 24-hour BP <120/80	59 28.5%
mean 24-hour SBP <135	140 67.6%
mean 24-hour SBP <130	120 58%
mean 24-hour SBP <125	92 44.4%
mean 24-hour SBP <120	59 28.5%
mean 24-hour DBP <85	158 76.3%
mean 24-hour DBP <80	146 70.5%
mean 24-hour DBP <75	121 58.5%

7. Secondary Outcome

Title	Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12
Description	number of participants achieving mean daytime ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12
Time Frame	week 0 - week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	165
mean daytime BP < 135/85	116 56%
mean daytime BP < 130/80	83 40.1%
mean daytime BP < 125/75	48 23.2%
mean daytime BP < 120/80	42 20.3%
mean daytime SBP < 135	118 57%
mean daytime SBP < 130	94 45.4%
mean daytime SBP < 125	67 32.4%
mean daytime SBP < 120	42 20.3%
mean daytime DBP < 85	151 72.9%
mean daytime DBP < 80	124 59.9%
mean daytime DBP < 75	91 44%

8. Secondary Outcome

Title	Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12
Description	number of participants achieving mean nighttime ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, BP<120/70, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75, DBP<70 at week 12
Time Frame	week 0 - week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	165
mean nighttime BP < 135/85	152 73.4%
mean nighttime BP < 130/80	137 66.2%
mean nighttime BP < 125/75	119 57.5%
mean nighttime BP < 120/80	112 54.1%
mean nighttime BP < 120/70	101 48.8%
mean nighttime SBP < 135	154 74.4%
mean nighttime SBP < 130	139 67.1%
mean nighttime SBP < 125	123 59.4%
mean nighttime SBP < 120	112 54.1%
mean nighttime DBP < 85	160 77.3%
mean nighttime DBP < 80	158 76.3%
mean nighttime DBP < 75	147 71%
mean nighttime DBP < 70	124 59.9%

9. Secondary Outcome

Title	Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12
Description	number participants achieving mean last 6 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12
Time Frame	week 0 - week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	165
mean last 6 hour BP < 135/85	135 65.2%
mean last 6 hour BP < 130/80	124 59.9%
mean last 6 hour BP < 125/75	101 48.8%
mean last 6 hour BP < 120/80	85 41.1%
mean last 6 hour SBP < 135	143 69.1%
mean last 6 hour SBP < 130	127 61.4%
mean last 6 hour SBP < 125	108 52.2%
mean last 6 hour SBP < 120	85 41.1%
mean last 6 hour DBP < 85	157 75.8%
mean last 6 hour DBP < 80	146 70.5%
mean last 6 hour DBP < 75	130 62.8%

10. Secondary Outcome

Title	Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12
Description	number of participants achieving mean last 4 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12
Time Frame	week 0 - week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	165
mean last 4 hour BP < 135/85	129 62.3%
mean last 4 hour BP < 130/80	107 51.7%
mean last 4 hour BP < 125/75	92 44.4%
mean last 4 hour BP < 120/80	72 34.8%
mean last 4 hour SBP < 135	131 63.3%
mean last 4 hour SBP < 130	114 55.1%
mean last 4 hour SBP < 125	102 49.3%
mean last 4 hour SBP < 120	72 34.8%
mean last 4 hour DBP < 85	150 72.5%
mean last 4 hour DBP < 80	137 66.2%
mean last 4 hour DBP < 75	120 58%

11. Secondary Outcome

Title	Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12
Description	number of participants achieving mean last 2 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12
Time Frame	week 0 - week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	165
mean last 2 hour BP < 135/85	110 53.1%
mean last 2 hour BP < 130/80	85 41.1%
mean last 2 hour BP < 125/75	63 30.4%
mean last 2 hour BP < 120/80	49 23.7%
mean last 2 hour SBP < 135	115 55.6%
mean last 2 hour SBP < 130	92 44.4%
mean last 2 hour SBP < 125	76 36.7%
mean last 2 hour SBP < 120	51 24.6%
mean last 2 hour DBP < 85	145 70%
mean last 2 hour DBP < 80	125 60.4%
mean last 2 hour DBP < 75	94 45.4%

12. Secondary Outcome

Title	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3
Description	number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 3
Time Frame	week 0 - week 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	201
mean BP < 135/85	31 15%
mean BP < 130/80	10 4.8%
mean BP < 125/75	4 1.9%
mean BP < 120/80	2 1%
mean SBP < 135	41 19.8%
mean SBP < 130	17 8.2%
mean SBP < 125	9 4.3%
mean SBP < 120	2 1%
mean DBP < 85	99 47.8%
mean DBP < 80	58 28%
mean DBP < 75	29 14%

13. Secondary Outcome

Title	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6
Description	number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 6
Time Frame	week 0 - week 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	192
mean BP < 135/85	61 29.5%
mean BP < 130/80	36 17.4%
mean BP < 125/75	18 8.7%
mean BP < 120/80	13 6.3%
mean SBP < 135	73 35.3%
mean SBP < 130	48 23.2%
mean SBP < 125	31 15%
mean SBP < 120	14 6.8%
mean DBP < 85	127 61.4%
mean DBP < 80	91 44%
mean DBP < 75	48 23.2%

14. Secondary Outcome

Title	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9
Description	number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 9
Time Frame	week 0 - week 9

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	184
mean BP < 135/85	76 36.7%
mean BP < 130/80	47 22.7%
mean BP < 125/75	25 12.1%
mean BP < 120/80	19 9.2%
mean SBP < 135	82 39.6%
mean SBP < 130	61 29.5%
mean SBP < 125	41 19.8%
mean SBP < 120	20 9.7%
mean DBP < 85	132 63.8%
mean DBP < 80	95 45.9%
mean DBP < 75	64 30.9%

15. Secondary Outcome

Title	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12
Description	number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12
Time Frame	week 0 - week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	177
mean BP < 135/85	86 41.5%
mean BP < 130/80	61 29.5%
mean BP < 125/75	33 15.9%
mean BP < 120/80	28 13.5%
mean SBP < 135	93 44.9%
mean SBP < 130	70 33.8%
mean SBP < 125	46 22.2%
mean SBP < 120	28 13.5%
mean DBP < 85	134 64.7%
mean DBP < 80	105 50.7%
mean DBP < 75	74 35.7%

16. Secondary Outcome

Title	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15
Description	number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 15
Time Frame	week 0 - week 15

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	172
mean BP < 135/85	114 55.1%
mean BP < 130/80	83 40.1%
mean BP < 125/75	51 24.6%
mean BP < 120/80	45 21.7%
mean SBP < 135	116 56%
mean SBP < 130	95 45.9%
mean SBP < 125	69 33.3%
mean SBP < 120	48 23.2%
mean DBP < 85	153 73.9%
mean DBP < 80	122 58.9%
mean DBP < 75	96 46.4%

17. Secondary Outcome

Title	Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18
Description	number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 18
Time Frame	week 0 - week 18

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	164
mean BP < 135/85	117 56.5%
mean BP < 130/80	87 42%
mean BP < 125/75	56 27.1%
mean BP < 120/80	49 23.7%
mean SBP < 135	123 59.4%
mean SBP < 130	101 48.8%
mean SBP < 125	74 35.7%
mean SBP < 120	51 24.6%
mean DBP < 85	147 71%
mean DBP < 80	128 61.8%
mean DBP < 75	94 45.4%

18. Secondary Outcome

Title	Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
Description	number of participants achieving mean 24 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12
Time Frame	week 0 - week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	165
mean 24-hour SBP reduction =<15 mm Hg	50 24.2%
mean 24-hour SBP reduction >15 & =<30 mm Hg	91 44%
mean 24-hour SBP reduction >30 & =<45 mm Hg	22 10.6%
mean 24-hour SBP reduction >45 mm Hg	2 1%
mean 24-hour DBP reduction =<10 mm Hg	72 34.8%
mean 24-hour DBP reduction >10 & =<15 mm Hg	47 22.7%
mean 24-hour DBP reduction >15 & =<20 mm Hg	31 15%
mean 24-hour DBP reduction >20 mm Hg	15 7.2%

19. Secondary Outcome

Title	Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
Description	number of participants achieving mean daytime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12
Time Frame	week 0 - week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	165
mean daytime SBP reduction =<15 mm Hg	47 22.7%
mean daytime SBP reduction >15 & =<30 mm Hg	84 40.6%
mean daytime SBP reduction >30 & =<45 mm Hg	31 15%
mean daytime SBP reduction >45 mm Hg	3 1.4%
mean daytime DBP reduction =<10 mm Hg	68 32.9%
mean daytime DBP reduction >10 & =<15 mm Hg	41 19.8%
mean daytime DBP reduction >15 & =<20 mm Hg	33 15.9%
mean daytime DBP reduction >20 mm Hg	23 11.1%

20. Secondary Outcome

Title	Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
Description	number of participants achieving mean nighttime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12
Time Frame	week 0 - week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	165
mean nighttime SBP reduction =<15 mm Hg	60 29%
mean nighttime SBP reduction >15 & =<30 mm Hg	79 38.2%
mean nighttime SBP reduction >30 & =<45 mm Hg	21 10.1%
mean nighttime SBP reduction >45 mm Hg	5 2.4%
mean nighttime DBP reduction =<10 mm Hg	80 38.6%
mean nighttime SBP reduction >10 & =<15 mm Hg	41 19.8%
mean nighttime SBP reduction >15 & =<20 mm Hg	21 10.1%
mean nighttime DBP reduction >20 mm Hg	23 11.1%

21. Secondary Outcome

Title	Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
Description	number of participants achieving mean last 6 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12
Time Frame	week 0 - week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	165
mean last 6 hour SBP reduction =<15 mm Hg	61 29.5%
mean last 6 hour SBP reduction >15 & =<30 mm Hg	76 36.7%
mean last 6 hour SBP reduction >30 & =<45 mm Hg	23 11.1%
mean last 6 hour SBP reduction >45 mm Hg	5 2.4%
mean last 6 hour DBP reduction =<10 mm Hg	76 36.7%
mean last 6 hour DBP reduction >10 & =<15 mm Hg	41 19.8%
mean last 6 hour DBP reduction >15 & =<20 mm Hg	27 13%
mean last 6 hour DBP reduction >20 mm Hg	21 10.1%

22. Secondary Outcome

Title	Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions
Description	number of participants achieving mean last 4 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12
Time Frame	week 0 - week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	165
mean last 4 hour SBP reduction =<15 mm Hg	67 32.4%
mean last 4 hour SBP reduction >15 & =<30 mm Hg	65 31.4%
mean last 4 hour SBP reduction >30 & =<45 mm Hg	28 13.5%
mean last 4 hour SBP reduction >45 mm Hg	5 2.4%
mean last 4 hour DBP reduction =<10 mm Hg	76 36.7%
mean last 4 hour DBP reduction >10 & =<15 mm Hg	36 17.4%
mean last 4 hour DBP reduction >15 & =<20 mm Hg	25 12.1%
mean last 4 hour DBP reduction >20 mm Hg	28 13.5%

23. Secondary Outcome

Title	Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
Description	number of participants achieving mean last 2 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12
Time Frame	week 0 - week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	165
mean last 2 hour SBP reduction =<15 mm Hg	63 30.4%
mean last 2 hour SBP reduction >15 & =<30 mm Hg	62 30%
mean last 2 hour SBP reduction >30 & =<45 mm Hg	35 16.9%
mean last 2 hour SBP reduction >45 mm Hg	5 2.4%
mean last 2 hour DBP reduction =<10 mm Hg	77 37.2%
mean last 2 hour DBP reduction >10 & =<15 mm Hg	28 13.5%
mean last 2 hour DBP reduction >15 & =<20 mm Hg	29 14%
mean last 2 hour DBP reduction >20 mm Hg	31 15%

24. Secondary Outcome

Title	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3
Description	number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 3
Time Frame	week 0 - week 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	201
mean seated SBP reduction =<15 mm Hg	131 63.3%
mean seated SBP reduction >15 & =<30 mm Hg	62 30%
mean seated SBP reduction >30 & =<45 mm Hg	6 2.9%
mean seated SBP reduction >45 mm Hg	2 1%
mean seated DBP reduction =<10 mm Hg	163 78.7%
mean seated DBP reduction >10 & =<15 mm Hg	25 12.1%
mean seated DBP reduction >15 & =<20 mm Hg	10 4.8%
mean seated DBP reduction >20 mm Hg	3 1.4%

25. Secondary Outcome

Title	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6
Description	number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 6
Time Frame	week 0 - week 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	192
mean seated SBP reduction =<15 mm Hg	69 33.3%
mean seated SBP reduction >15 & =<30 mm Hg	90 43.5%
mean seated SBP reduction >30 & =<45 mm Hg	31 15%
mean seated SBP reduction >45 mm Hg	2 1%
mean seated DBP reduction =<10 mm Hg	120 58%
mean seated DBP reduction >10 & =<15 mm Hg	33 15.9%
mean seated DBP reduction >15 & =<20 mm Hg	24 11.6%
mean seated DBP reduction >20 mm Hg	15 7.2%

26. Secondary Outcome

Title	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9
Description	number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 9
Time Frame	week 0 - week 9

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	184
mean seated SBP reduction =<15 mm Hg	72 34.8%
mean seated SBP reduction >15 & =<30 mm Hg	69 33.3%
mean seated SBP reduction >30 & =<45 mm Hg	34 16.4%
mean seated SBP reduction >45 mm Hg	9 4.3%
mean seated DBP reduction =<10 mm Hg	100 48.3%
mean seated DBP reduction >10 & =<15 mm Hg	43 20.8%
mean seated DBP reduction >15 & =<20 mm Hg	18 8.7%
mean seated DBP reduction >20 mm Hg	23 11.1%

27. Secondary Outcome

Title	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12
Description	number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12
Time Frame	week 0 - week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	177
mean seated SBP reduction =<15 mm Hg	48 23.2%
mean seated SBP reduction >15 & =<30 mm Hg	73 35.3%
mean seated SBP reduction >30 & =<45 mm Hg	45 21.7%
mean seated SBP reduction >45 mm Hg	11 5.3%
mean seated DBP reduction =<10 mm Hg	85 41.1%
mean seated DBP reduction >10 & =<15 mm Hg	42 20.3%
mean seated DBP reduction >15 & =<20 mm Hg	27 13%
mean seated DBP reduction >20 mm Hg	23 11.1%

28. Secondary Outcome

Title	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15
Description	number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 15
Time Frame	week 0 - week 15

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	172
mean seated SBP reduction =<15 mm Hg	31 15%
mean seated SBP reduction >15 & =<30 mm Hg	66 31.9%
mean seated SBP reduction >30 & =<45 mm Hg	55 26.6%
mean seated SBP reduction >45 mm Hg	20 9.7%
mean seated DBP reduction =<10 mm Hg	52 25.1%
mean seated DBP reduction >10 & =<15 mm Hg	45 21.7%
mean seated DBP reduction >15 & =<20 mm Hg	32 15.5%
mean seated DBP reduction >20 mm Hg	43 20.8%

29. Secondary Outcome

Title	Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18
Description	number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 18
Time Frame	week 0 - week 18

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aml + Olm + Hctz
Arm/Group Description	amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Measure Participants	164
mean seated SBP reduction =<15 mm Hg	22 10.6%
mean seated SBP reduction >15 & =<30 mm Hg	53 25.6%
mean seated SBP reduction >30 & =<45 mm Hg	64 30.9%
mean seated SBP reduction >45 mm Hg	25 12.1%
mean seated DBP reduction =<10 mm Hg	50 24.2%
mean seated DBP reduction >10 & =<15 mm Hg	33 15.9%
mean seated DBP reduction >15 & =<20 mm Hg	29 14%
mean seated DBP reduction >20 mm Hg	52 25.1%

Adverse Events

Arm/Group Title	ALL - Aml + Olm + Hctz		Start - Amlodipine 5 mg		Titration 1 - Amlodipine 5 mg / Olmesartan 20 mg		Titration 2 - Amlodipine 5 mg / Olmesartan 40 mg		Titration 3 - Amlodipine 10 mg / Olmesartan 40 mg		Titration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mg		Titration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg
Arm/Group Description	Summary of ALL participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required		All participants started trial on Amlodipine 5 mg.		Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.		Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.		Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.		Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.		Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
All Cause Mortality
	ALL - Aml + Olm + Hctz		Start - Amlodipine 5 mg		Titration 1 - Amlodipine 5 mg / Olmesartan 20 mg		Titration 2 - Amlodipine 5 mg / Olmesartan 40 mg		Titration 3 - Amlodipine 10 mg / Olmesartan 40 mg		Titration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mg		Titration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	ALL - Aml + Olm + Hctz		Start - Amlodipine 5 mg		Titration 1 - Amlodipine 5 mg / Olmesartan 20 mg		Titration 2 - Amlodipine 5 mg / Olmesartan 40 mg		Titration 3 - Amlodipine 10 mg / Olmesartan 40 mg		Titration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mg		Titration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/207 (1.9%)		0/207 (0%)		0/195 (0%)		1/177 (0.6%)		0/167 (0%)		1/146 (0.7%)		2/101 (2%)
Infections and infestations
pneumonia	1/207 (0.5%)	1	0/207 (0%)	0	0/195 (0%)	0	0/177 (0%)	0	0/167 (0%)	0	0/146 (0%)	0	1/101 (1%)	1
Metabolism and nutrition disorders
hyperkalaemia	1/207 (0.5%)	1	0/207 (0%)	0	0/195 (0%)	0	0/177 (0%)	0	0/167 (0%)	0	1/146 (0.7%)	1	0/101 (0%)	0
Nervous system disorders
presyncope	1/207 (0.5%)	1	0/207 (0%)	0	0/195 (0%)	0	0/177 (0%)	0	0/167 (0%)	0	1/146 (0.7%)	1	0/101 (0%)	0
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease	1/207 (0.5%)	1	0/207 (0%)	0	0/195 (0%)	0	1/177 (0.6%)	1	0/167 (0%)	0	0/146 (0%)	0	1/101 (1%)	1
Other (Not Including Serious) Adverse Events
	ALL - Aml + Olm + Hctz		Start - Amlodipine 5 mg		Titration 1 - Amlodipine 5 mg / Olmesartan 20 mg		Titration 2 - Amlodipine 5 mg / Olmesartan 40 mg		Titration 3 - Amlodipine 10 mg / Olmesartan 40 mg		Titration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mg		Titration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	80/207 (38.6%)		16/207 (7.7%)		15/195 (7.7%)		10/177 (5.6%)		21/167 (12.6%)		14/146 (9.6%)		4/101 (4%)
Blood and lymphatic system disorders
anaemia	7/207 (3.4%)	7	0/207 (0%)	0	0/195 (0%)	0	0/177 (0%)	0	4/167 (2.4%)	4	1/146 (0.7%)	1	2/101 (2%)	2
General disorders
oedema peripheral	20/207 (9.7%)	20	7/207 (3.4%)	7	3/195 (1.5%)	3	2/177 (1.1%)	2	7/167 (4.2%)	7	1/146 (0.7%)	1	0/101 (0%)	0
Infections and infestations
upper respiratory tract infection	11/207 (5.3%)	11	0/207 (0%)	0	2/195 (1%)	2	3/177 (1.7%)	3	3/167 (1.8%)	3	3/146 (2.1%)	3	0/101 (0%)	0
bronchitis	5/207 (2.4%)	5	1/207 (0.5%)	1	2/195 (1%)	2	0/177 (0%)	0	1/167 (0.6%)	1	1/146 (0.7%)	1	0/101 (0%)	0
Musculoskeletal and connective tissue disorders
pain in extremity	5/207 (2.4%)	5	1/207 (0.5%)	1	2/195 (1%)	2	1/177 (0.6%)	1	0/167 (0%)	0	1/146 (0.7%)	1	0/101 (0%)	0
arthralgia	5/207 (2.4%)	5	1/207 (0.5%)	1	3/195 (1.5%)	3	0/177 (0%)	0	1/167 (0.6%)	1	0/146 (0%)	0	0/101 (0%)	0
Nervous system disorders
dizziness	12/207 (5.8%)	12	3/207 (1.4%)	3	1/195 (0.5%)	1	2/177 (1.1%)	2	1/167 (0.6%)	1	5/146 (3.4%)	5	0/101 (0%)	0
headache	6/207 (2.9%)	6	3/207 (1.4%)	3	0/195 (0%)	0	0/177 (0%)	0	2/167 (1.2%)	2	0/146 (0%)	0	1/101 (1%)	1
Respiratory, thoracic and mediastinal disorders
cough	5/207 (2.4%)	5	0/207 (0%)	0	1/195 (0.5%)	1	2/177 (1.1%)	2	2/167 (1.2%)	2	0/146 (0%)	0	0/101 (0%)	0
Vascular disorders
hypotension	4/207 (1.9%)	4	0/207 (0%)	0	1/195 (0.5%)	1	0/177 (0%)	0	0/167 (0%)	0	2/146 (1.4%)	2	1/101 (1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Sponsor reflects the following restrictive language in the Clinical Study Agreements: "If identified by Daiichi Sankyo Inc. (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 publication prepared by the Study Site."