Hypertension
Conditions
Keywords
Hypertension, Angiotensin Receptor Blocker, Calcium Channel Blocker, Angiotensin Converting Enzyme Inhibitor, Hydrochlorothiazide, Stage I and II Hypertension
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.
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.
Interventions
olmesartan medoxomil + hydrochlorothiazide, if necessary. Oral tablets administered for once daily for 12 weeks
DRUGPlacebo
Oral tablets administered for once daily for 12 weeks
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 | — |
| 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 | — |
| 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 | — |
| 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 | — |
| 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 | — |
| 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 | — |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Olmesartan Group 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). | 138 |
| Placebo Group Participants were randomized to a placebo (Pbo) group. The Pbo participants remained in the pbo group for the entire 12 weeks of treatment. | 138 |
| Total | 276 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 15 | 15 |
| Overall Study | Lost to Follow-up | 1 | 7 |
| Overall Study | Non-compliant | 2 | 1 |
| Overall Study | Other | 2 | 2 |
| Overall Study | Protocol Violation | 6 | 4 |
| Overall Study | Uncontrolled blood pressure | 48 | 13 |
| Overall Study | Withdrawal by Subject | 4 | 6 |
Baseline characteristics
| Characteristic | Placebo Group | Olmesartan Group | Total |
|---|---|---|---|
| Age, Continuous | 55.8 years FULL_RANGE 9.47 | 55.9 years FULL_RANGE 10.74 | 55.9 years FULL_RANGE 10.1 |
| Diastolic BP | 93.7 mm Hg | 94.2 mm Hg FULL_RANGE 7.7 | 94.0 mm Hg |
| Heart Rate | 73.6 Beats/minute | 75.1 Beats/minute FULL_RANGE 10.84 | 74.4 Beats/minute |
| Region of Enrollment United States | 138 participants | 138 participants | 276 participants |
| Sex: Female, Male Female | 72 Participants | 75 Participants | 147 Participants |
| Sex: Female, Male Male | 66 Participants | 63 Participants | 129 Participants |
| Systolic BP | 155.4 mm Hg | 156.9 mm Hg FULL_RANGE 9.19 | 156.2 mm Hg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 46 / 138 | 55 / 140 |
| serious Total, serious adverse events | 0 / 138 | 3 / 140 |
Outcome results
Primary
Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device. | -0.1 mm Hg | Standard Error 1.4 |
| Olmesartan Group | Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device. | -22.3 mm Hg | Standard Error 1.39 |
Comparison: 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.p-value: <0.0001ANCOVA
Secondary
Change From Baseline in Mean Diastolic Blood Pressure (DBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Mean Diastolic Blood Pressure (DBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device. | -0.8 mm Hg | Standard Error 0.78 |
| Olmesartan Group | Change From Baseline in Mean Diastolic Blood Pressure (DBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device. | -12.1 mm Hg | Standard Error 0.77 |
Comparison: 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.p-value: <0.0001ANCOVA
Secondary
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
Population: 55 Black participants from both the olmesartan and placebo groups were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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. | Diastolic blood pressure | -12.5 mm Hg | Standard Deviation 2.72 |
| Placebo | 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. | Systolic blood pressure | -21.3 mm Hg | Standard Deviation 4.97 |
Comparison: 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 comparisonsp-value: <0.0001ANCOVA
Comparison: 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 comparisonsp-value: <0.0001ANCOVA
Secondary
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.
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
Population: 145 female participants from both the olmesartan and placebo groups were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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. | Systolic blood pressure | -21.6 mm Hg | Standard Deviation 2.6 |
| Placebo | 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. | Diastolic blood pressure | -12.0 mm Hg | Standard Deviation 1.38 |
Comparison: 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.p-value: <0.0001ANCOVA
Comparison: 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.p-value: <0.0001ANCOVA
Secondary
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.
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
Population: 131 male participants
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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. | Systolic Blood Pressure | -22.6 mm Hg | Standard Error 2.94 |
| Placebo | 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. | Diastolic Blood Pressure | -13.5 mm Hg | Standard Error 1.66 |
Comparison: 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.p-value: <0.0001ANCOVA
Comparison: 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.p-value: <0.0001ANCOVA
Secondary
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
Population: 221 non-Black participants from both the olmesartan and placebo groups were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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. | Systolic blood pressure | -22.3 mm Hg | Standard Deviation 2.14 |
| Placebo | 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. | Diastolic blood pressure | -12.8 mm Hg | Standard Deviation 1.18 |
Comparison: 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 comparisonsp-value: <0.0001ANCOVA
Comparison: 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 comparisonsp-value: <0.0001ANCOVA
Secondary
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
Population: 44 participants of greater than 65 years of age, from both the olmesartan and placebo groups were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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. | Systolic blood pressure | -16.1 mm Hg | Standard Deviation 6.18 |
| Placebo | 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. | Diastolic blood pressure | -9.0 mm Hg | Standard Deviation 2.42 |
Comparison: 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.p-value: 0.0125ANCOVA
Comparison: 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.p-value: 0.0006ANCOVA
Secondary
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
Population: 232 participants from both the olmesartan and placebo groups, less than 65 years of age, were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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. | Systolic blood pressure | -23.8 mm Hg | Standard Deviation 2.04 |
| Placebo | 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. | Diastolic blood pressure | -13.6 mm Hg | Standard Deviation 1.17 |
Comparison: 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.p-value: <0.0001ANCOVA
Comparison: 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.p-value: <0.0001ANCOVA
Secondary
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
Population: 130 Stage 1 hypertensive participants from both the olmesartan and placebo groups.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Systolic blood pressure | -22.1 mm Hg | Standard Deviation 2.43 |
| Placebo | 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 | Diastolic blood pressure | -12.2 mm Hg | Standard Deviation 1.39 |
Comparison: 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 comparisonsp-value: <0.0001ANCOVA
Comparison: 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 comparisonsp-value: <0.0001ANCOVA
Secondary
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
Population: 146 Stage 2 hypertensive participants from both the olmesartan and placebo groups
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Systolic blood pressure | -22.5 mm Hg | Standard Deviation 3.07 |
| Placebo | 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 | Diastolic blood pressure | -13.2 mm Hg | Standard Deviation 1.65 |
Comparison: 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 comparisonsp-value: <0.0001ANCOVA
Comparison: 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 comparisonsp-value: <0.0001ANCOVA