A Study of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Stage I and Stage II Hypertension

• Sponsor: Daiichi Sankyo, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00430638
• Collaborator: (none)
• Enrollment: 278
• Locations: 29
• Arms: 2
• Duration (Months): 10
• Patients Per Site: 9.6
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

This 16 week study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients with moderate to severe high blood pressure in comparison to placebo. The medication being tested has been approved by the FDA for the treatment of high blood pressure.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary; Drug: Placebo	Phase 4

Detailed Description

This study was to randomize an equal number of participants to either an olmesartan medoxomil based treatment or to placebo. The titration scheme was as follows:

• First 3 weeks (wks), all participants - olmesartan medoxomil 20 mg or placebo

• Next 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg or placebo

• Next 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg/HCT 12.5 mg or placebo

• Final 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg/HCT 25 mg or placebo

• Subjects with a mean BP of <120/80 mmHg at any visit were considered responders and were not titrated up to the next dose level. However, they remained in the study at their currently assigned dose of study medication.

• Subjects with a mean office SBP ≥120 mmHg or a mean office DBP ≥80 mmHg at any subsequent visit(s) were considered 'uncontrolled' and were titrated to the next dose level according to the titration scheme above.

• Subjects who reach the highest dose (ie, olmesartan medoxomil 40 mg/HCT 25 mg) remained on that dose until study exit at Visit 8, unless safety concerns caused discontinuation of treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 278 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Randomized, Placebo Controlled, Parallel Group Study to Compare the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen to Placebo in Patients With Stage I and Stage II Hypertension
• Study Start Date: Dec 1, 2006
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Olmesartan medoxomil, plus hydrochlorothiazide, if necessary	Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary; olmesartan medoxomil + hydrochlorothiazide, if necessary. Oral tablets administered for once daily for 12 weeks
Placebo Comparator: Placebo Placebo tablets were taken once daily for 12 weeks	Drug: Placebo; Oral tablets administered for once daily for 12 weeks

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device. [baseline to 12 weeks]

   The change from baseline in mean systolic blood pressure (SBP) after 12 weeks of randomized treatment was compared between the olmesartan based treatment group and the placebo treatment group.

Secondary Outcome Measures

1. Change From Baseline in Mean Diastolic Blood Pressure (DBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device. [baseline to 12 weeks]

   Change from study baseline (average of triplicate DBP measurements at the last 2 qualifying visits during placebo run-in period) in DBP to the end of 12 weeks of randomized treatment using a last observation carried forward (LOCF) approach.

2. The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Males. [Baseline to week 12]

   The difference in the change from baseline to week 12 in seated systolic and diastolic blood pressure for males in the olmesartan group vs. the placebo group was analyzed.

3. The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Females. [Baseline to week 12]

   The difference in the change from baseline to week 12 in seated blood pressure for females in the olmesartan group vs. the placebo group was analyzed.

4. The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Less Than 65 Years Old. [Baseline to 12 weeks]

5. The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Greater Than or Equal to 65 Years Old. [Baseline to 12 weeks]

6. The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Black Participants. [Baseline to week 12]

7. The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Non-Black Participants. [Baseline to 12 weeks]

8. The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 1 Hypertensives [Baseline to 12 weeks]

9. The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 2 Hypertensives [Baseline to 12 months]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Greater than or equal to 18 years of age.

• Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mmHg but less than or equal to 179 mmHg and a mean seated diastolic blood pressure (MSDBP) less than or equal to 109 mmHg following a 3 to 4-week single-blind placebo run-in period.

• The difference in MSSBP between Visits 3 and 4 or between Visits 4 and 4X must be less than or equal to 10 mmHg.

• Patients with a mean daytime (8AM-4PM) systolic blood pressure (SBP) greater than or equal to 135 mmHg and less than or equal to 179 mmHg and a mean daytime diastolic blood pressure (DBP) less than or equal to 109 mmHg as measured by an ambulatory blood pressure monitoring device (ABPM) following placebo run-in period.

• If female, must have negative serum pregnancy test at screening and be either post-menopausal (greater than or equal to 1 year), had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study.

Exclusion Criteria:

• History of stroke or transient ischemic attack (TIA) within the last one year.

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

• Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome.

• Type I diabetes. Patients with Type II diabetes on stable treatment, with fasting glucose <160 mg/dl may enroll.

• Patients with hemodynamically significant cardiac valvular disease.

• Patients with clinically significant cardiac conduction defects, including first, second or third degree AV block, left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States
2		Mobile	Alabama	United States
3		Muscle Shoals	Alabama	United States
4		Searcy	Arkansas	United States
5		Carmichael	California	United States
6		Spring Valley	California	United States
7		Coral Gables	Florida	United States
8		Deerfield Beach	Florida	United States
9		DeLand	Florida	United States
10		Fort Lauderdale	Florida	United States
11		Hialeah	Florida	United States
12		Hollywood	Florida	United States
13		Pembroke Pines	Florida	United States
14		Chicago	Illinois	United States
15		Elizabeth	New Jersey	United States
16		Winston-Salem	North Carolina	United States
17		Cincinnati	Ohio	United States
18		Oklahoma City	Oklahoma	United States
19		Eugene	Oregon	United States
20		Downingtown	Pennsylvania	United States
21		Charleston	South Carolina	United States
22		Nashville	Tennessee	United States
23		New Tazewell	Tennessee	United States
24		Colleyville	Texas	United States
25		San Antonio	Texas	United States
26		Murray	Utah	United States
27		Manassas	Virginia	United States
28		Olympia	Washington	United States
29		Madison	Wisconsin	United States

Sponsors and Collaborators

• Daiichi Sankyo, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daiichi Sankyo, Inc.
• ClinicalTrials.gov Identifier: NCT00430638
• Other Study ID Numbers: 866-451
• First Posted: Feb 2, 2007
• Last Update Posted: Oct 2, 2018
• Last Verified: Sep 1, 2018

• Keywords provided by Daiichi Sankyo, Inc.: Hypertension; Angiotensin Receptor Blocker; Calcium Channel Blocker; Angiotensin Converting Enzyme Inhibitor; Hydrochlorothiazide; Stage I and II Hypertension
• Additional relevant MeSH terms: Hypertension; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil

Study Results

Participant Flow

Recruitment Details	Subjects were recruited at 29 US sites (private medical practices and small clinics) over 5 months from December 2006 to May 2007 from each physician's clientele base. About 450 potential subjects were to be screened so that about 250 eligible subjects, men and women at least 18 years of age with stage I or II hypertension, were randomized.
Pre-assignment Detail	After 3-4 weeks of placebo treatment, eligible subjects were randomized. 140 were randomized to drug; 138 to placebo. 2 active drug participants were given the wrong dose at entry. Because only 138 participants received Olmesartan 20 mg, any demography data totals are equal to 276 instead of 278. The subgroup analyses are similarly affected.

Arm/Group Title	Placebo (Pbo) Group	Olmesartan Group
Arm/Group Description	138 were randomized to placebo. Participants remained in the placebo group for the duration of the study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on placebo matching olmesartan 20 mg; after 3 weeks, if necessary, placebo matching olmesartan 40 mg; after 6 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 25 mg.	140 participants were randomized to the olmesartan group. These participants remained in this group for the entire study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on olmesartan 20 mg; after 3 weeks, if necessary, olmesartan 40 mg; after 6 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 25 mg.
Period Title: Overall Study
STARTED	138	140
COMPLETED	60	92
NOT COMPLETED	78	48

Baseline Characteristics

Arm/Group Title	Olmesartan Group	Placebo Group	Total
Arm/Group Description	Participants were randomized to an olmesartan (Olm) based active treatment group. After 3,6,and 9 weeks of treatment participants were titrated to the next regiment if their blood pressure was greater than 120/80 mmHg. The active treatment group received olm 20 mg (weeks 1-3), olm 40 mg (weeks 4-6), olm 40 mg + 12.5 mg hydrchlorothiazide (HCTZ) (weeks 7-9), and olm 40 mg + 25 mg HCTZ (weeks 10-12).	Participants were randomized to a placebo (Pbo) group. The Pbo participants remained in the pbo group for the entire 12 weeks of treatment.	Total of all reporting groups
Overall Participants	138	138	276
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	55.9 (10.74)	55.8 (9.47)	55.9 (10.1)
Sex: Female, Male (Count of Participants)
Female	75 54.3%	72 52.2%	147 53.3%
Male	63 45.7%	66 47.8%	129 46.7%
Region of Enrollment (participants) [Number]
United States	138 100%	138 100%	276 100%
Diastolic BP (mm Hg) [Mean (Full Range) ]
Mean (Full Range) [mm Hg]	94.2 (7.7)	93.7	94.0
Heart Rate (Beats/minute) [Mean (Full Range) ]
Mean (Full Range) [Beats/minute]	75.1 (10.84)	73.6	74.4
Systolic BP (mm Hg) [Mean (Full Range) ]
Mean (Full Range) [mm Hg]	156.9 (9.19)	155.4	156.2

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.
Description	The change from baseline in mean systolic blood pressure (SBP) after 12 weeks of randomized treatment was compared between the olmesartan based treatment group and the placebo treatment group.
Time Frame	baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

The efficacy cohort is defined as any subject who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline efficacy blood pressure assessment. 140 participants were originally randomized to the olmesartan group. 139 is the correct number analyzed. For the placebo group the efficacy cohort = 137.

Arm/Group Title	Placebo	Olmesartan Group
Arm/Group Description	Patient received placebo tablets.	Participants received olmesatan medoxomil plus hydrochlorothiazide, if necessary.
Measure Participants	137	139
Least Squares Mean (Standard Error) [mm Hg]	-0.1 (1.40)	-22.3 (1.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Olmesartan Group
	Comments	Null hypothesis: For the entire efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	No multiplicity adjustments
	Method	ANCOVA
	Comments	The ANCOVA model included randomized treatment and baseline cuff blood pressure stage as factors and study baseline systolic BP value as a covariate.

2. Secondary Outcome

Title	Change From Baseline in Mean Diastolic Blood Pressure (DBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.
Description	Change from study baseline (average of triplicate DBP measurements at the last 2 qualifying visits during placebo run-in period) in DBP to the end of 12 weeks of randomized treatment using a last observation carried forward (LOCF) approach.
Time Frame	baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

The efficacy cohort is defined as any subject who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline efficacy blood pressure assessment. 140 participants were originally randomized to the olmesartan group, but two were erroneously started with the 40mg dose. 139 is the correct number analyzed.

Arm/Group Title	Placebo Group	Olmesartan Group
Arm/Group Description	Patient received placebo tablets throughout the 12-week active treatment period.	Participants received olmesartan medoxomil tablets + hydrochlorothiazide tablets, if necessary, once daily for the duration of the 12-week active treatment period.
Measure Participants	137	139
Least Squares Mean (Standard Error) [mm Hg]	-0.8 (0.78)	-12.1 (0.77)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Olmesartan Group
	Comments	Null hypothesis: For the entire efficacy population, Olmesartan had the same effect on change from baseline in diastolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	The ANCOVA Model included randomized treatment and baseline cuff BP stage as factors and study baseline diastolic BP as a covariate.

3. Secondary Outcome

Title	The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Males.
Description	The difference in the change from baseline to week 12 in seated systolic and diastolic blood pressure for males in the olmesartan group vs. the placebo group was analyzed.
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

131 male participants

Arm/Group Title	Olmesartan vs. Placebo
Arm/Group Description
Measure Participants	131
Systolic Blood Pressure	-22.6 (2.94)
Diastolic Blood Pressure	-13.5 (1.66)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Null hypothesis (male systolic blood pressure (SBP)): For the male efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Null hypothesis (Males - diastolic blood pressure (DBP)): For the male efficacy population, Olmesartan had the same effect on change from baseline in diastolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

4. Secondary Outcome

Title	The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Females.
Description	The difference in the change from baseline to week 12 in seated blood pressure for females in the olmesartan group vs. the placebo group was analyzed.
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

145 female participants from both the olmesartan and placebo groups were analyzed.

Arm/Group Title	Olmesartan vs. Placebo
Arm/Group Description	145 females participants were analyzed.
Measure Participants	145
Systolic blood pressure	-21.6 (2.6)
Diastolic blood pressure	-12.0 (1.38)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Null hypothesis (Systolic blood pressure (SBP) - females): For the female efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Null hypothesis (Diastolic blood pressure (DBP) - females): For the female efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

5. Secondary Outcome

Title	The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Less Than 65 Years Old.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

232 participants from both the olmesartan and placebo groups, less than 65 years of age, were analyzed.

Arm/Group Title	Olmesartan vs. Placebo
Arm/Group Description
Measure Participants	232
Systolic blood pressure	-23.8 (2.04)
Diastolic blood pressure	-13.6 (1.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Null hypothesis(Systolic blood pressure (SBP) - less than 65 years of age): For the efficacy population < 65 years of age, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Null hypothesis (Diastolic blood pressure (DBP) - less than 65 years of age): For the efficacy population < 65 years of age, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

6. Secondary Outcome

Title	The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Greater Than or Equal to 65 Years Old.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

44 participants of greater than 65 years of age, from both the olmesartan and placebo groups were analyzed.

Arm/Group Title	Olmesartan vs. Placebo
Arm/Group Description
Measure Participants	44
Systolic blood pressure	-16.1 (6.18)
Diastolic blood pressure	-9.0 (2.42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Null hypothesis (Systolic blood pressure (SBP) - > or equal to 65 years old): For the efficacy population > or = to 65 years of age, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0125
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Null hypothesis (Diastolic blood pressure (DBP) > or equal to 65): For the efficacy population > or = to 65 years of age, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0006
	Comments
	Method	ANCOVA
	Comments

7. Secondary Outcome

Title	The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Black Participants.
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

55 Black participants from both the olmesartan and placebo groups were analyzed.

Arm/Group Title	Olmesartan vs. Placebo
Arm/Group Description
Measure Participants	55
Systolic blood pressure	-21.3 (4.97)
Diastolic blood pressure	-12.5 (2.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Null hypothesis (Systolic blood pressure (SBP) - Black participants): For the Black efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Null hypothesis (Diastolic blood pressure (DBP) - Black participants): For the Black efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

8. Secondary Outcome

Title	The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Non-Black Participants.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

221 non-Black participants from both the olmesartan and placebo groups were analyzed.

Arm/Group Title	Olmesartan vs. Placebo
Arm/Group Description
Measure Participants	221
Systolic blood pressure	-22.3 (2.14)
Diastolic blood pressure	-12.8 (1.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Null hypothesis(Systolic blood pressure (SBP) - non-Black participants): For the Non-Black efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Null hypothesis(Diastolic blood pressure (DBP) - non-Black participants): For the Non-Black efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

9. Secondary Outcome

Title	The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 1 Hypertensives
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

130 Stage 1 hypertensive participants from both the olmesartan and placebo groups.

Arm/Group Title	Olmesartan vs. Placebo
Arm/Group Description
Measure Participants	130
Systolic blood pressure	-22.1 (2.43)
Diastolic blood pressure	-12.2 (1.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Null hypothesis(Systolic blood pressure (SBP) - Stage 1 hypertensive participants): For the Stage 1 efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Null hypothesis (Diastolic blood pressure (DBP) - Stage 1 hypertensive participants): For the Stage 1 efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

10. Secondary Outcome

Title	The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 2 Hypertensives
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description

146 Stage 2 hypertensive participants from both the olmesartan and placebo groups

Arm/Group Title	Olmesartan vs. Placebo
Arm/Group Description
Measure Participants	146
Systolic blood pressure	-22.5 (3.07)
Diastolic blood pressure	-13.2 (1.65)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Null hypothesis (Systolic blood pressure (SBP) - Stage 2 hypertensive participants): For the Stage 2 efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Null hypothesis (Diastolic blood pressure (DBP) - Stage 2 hypertensive participants): For the Stage 2 efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

Adverse Events

Time Frame	12-week randomized, treatment period plus 30 days after the last dose of study medication.
Adverse Event Reporting Description	All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.
Arm/Group Title	Placebo (Pbo) Group		Olmesartan Group
Arm/Group Description	138 were randomized to placebo. Participants remained in the placebo group for the duration of the study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on placebo matching olmesartan 20 mg; after 3 weeks, if necessary, placebo matching olmesartan 40 mg; after 6 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 25 mg.		140 participants were randomized to the olmesartan group. These participants remained in this group for the entire study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on olmesartan 20 mg; after 3 weeks, if necessary, olmesartan 40 mg; after 6 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 25 mg.
All Cause Mortality
	Placebo (Pbo) Group		Olmesartan Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo (Pbo) Group		Olmesartan Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/138 (0%)		3/140 (2.1%)
Cardiac disorders
Supraventricular tachycardia	0/138 (0%)		1/140 (0.7%)
Gastrointestinal disorders
Small Intestine Obstruction	0/138 (0%)		1/140 (0.7%)
Vascular disorders
Hypertension	0/138 (0%)		1/140 (0.7%)
Other (Not Including Serious) Adverse Events
	Placebo (Pbo) Group		Olmesartan Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	46/138 (33.3%)		55/140 (39.3%)
Immune system disorders
Seasonal allergy	2/138 (1.4%)		3/140 (2.1%)
Infections and infestations
Upper respiratory tract infection	7/138 (5.1%)		9/140 (6.4%)
Urinary tract infection	0/138 (0%)		4/140 (2.9%)
Viral upper respiratory infection	7/138 (5.1%)		1/140 (0.7%)
Musculoskeletal and connective tissue disorders
Back pain	4/138 (2.9%)		8/140 (5.7%)
Nervous system disorders
Dizziness	1/138 (0.7%)		13/140 (9.3%)
Headache	17/138 (12.3%)		11/140 (7.9%)
Respiratory, thoracic and mediastinal disorders
Cough	7/138 (5.1%)		3/140 (2.1%)
Vascular disorders
Hypertension	1/138 (0.7%)		3/140 (2.1%)

Limitations/Caveats

[Not Specified]

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