Hypertension
Conditions
Brief summary
This study will evaluate the efficacy and safety of the FDA approved blood pressure medication olmesartan medoxomil compared to the FDA approved medication losartan potassium.
Interventions
DRUGolmesartan medoxomil
Oral tablets, once daily, at either 20mg or 40mg daily.
DRUGPlacebo
placebo oral tablets once daily for two weeks
DRUGlosartan potassium
losartan potassium oral tablet at either 50mg or 100 mg daily dose.
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
* Males or females aged \> 18 years who are not institutionalized and have signed informed consent. * Mean cuff seated diastolic blood pressure (BP) must be \> 95 mmHg and \< 115 mmHg and a mean cuff seated systolic BP must be \< 180 mmHg when measured at two consecutive qualification study visits during the placebo run-in phase. * The difference in mean cuff seated diastolic BP must be \< 7 mmHg between two consecutive qualification study visits during the placebo run-in phase.
Exclusion criteria
* Subjects with type 2 diabetes mellitus with an HbA1c ≥ 9.5% at Screening. * Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of olmesartan medoxomil and losartan potassium, including cardiovascular, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic (with the exception of non-insulin, dependent type 2 diabetes mellitus with HbA1c \< 9.5% at Screening), hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases. * Subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or heart failure within the last 12 months. * Subjects with any history of New York Heart Association Class III or IV congestive heart failure (CHF). A history of New York Heart Association Class I or II CHF may be exclusionary at the discretion of the Investigator. * Subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year. * Subjects with clinically significant cardiac conduction defects, including second or third degree atrioventricular (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 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | Day 0, Week 8 | The change from baseline in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | Day 0, Week 4 | The change from baseline in trough SSBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit. |
| Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | Day 0, Week 8 | The change from baseline in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit. |
| Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | Day 0, Week 4 | The change from baseline in trough SDBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4 | Baseline, Week 4 | In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. |
| Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8 | Baseline, Week 8 | In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. |
| Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4 | Baseline, Week 4 | In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized. |
| Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | Week 4, Week 8 | The change from Week 4 in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit. |
| Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 | Baseline, Week 4 | In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized. |
| Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 | Baseline, Week 8 | In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized. |
| Change From Baseline to Week 2 in Trough, Cuff, Seated Blood Pressure | Baseline, Week 2 | The change from baseline in trough systolic and diastolic blood pressure at Week 2 as measured by the Omron monitor. Morning doses of study medication were taken after the exam, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit. |
| Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8 | Baseline, Week 8 | In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized. |
| Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | Week 4, Week 8 | The change from Week 4 in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit. |
| Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Week 4 | Percentage of participants who achieved the following goals: Systolic blood pressure: \<140 mmHg, \<135 mmHg, \<130 mmHg, \<120 mmHg Diastolic blood pressure: \<90 mmHg, \<85 mmHg, \<80 mmHg Blood pressure: \<140/90 mmHg, \<135/80 mmHg, \<130/80 mmHg |
| Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Week 8 | Percentage of participants who achieved the following goals: Systolic blood pressure: \<140 mmHg, \<135 mmHg, \<130 mmHg, \<120 mmHg Diastolic blood pressure: \<90 mmHg, \<85 mmHg, \<80 mmHg Blood pressure: \<140/90 mmHg, \<135/80 mmHg, \<130/80 mmHg, \<120/80 mmHg |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at 119 out-patient centers throughout the U.S.: 1976 patients were screened, 1632 were enrolled, and 941 randomized.
Pre-assignment details
Prior to group assignment was a 2-9 day screening period and a 3-4 week single-blind (participant was blinded) placebo run-in period. Participants were randomized in an 8:1:9 ratio to treatment arms as listed.
Participants by arm
| Arm | Count |
|---|---|
| Olmesartan Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks. | 420 |
| Placebo Followed by Olmesartan Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks | 52 |
| Losartan Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks | 469 |
| Total | 941 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 14 | 3 | 12 |
| Overall Study | Did not meet inclusion/exclusion | 2 | 1 | 3 |
| Overall Study | Lack of Efficacy | 4 | 2 | 7 |
| Overall Study | Lost to Follow-up | 7 | 5 | 5 |
| Overall Study | Physician Decision | 5 | 0 | 6 |
| Overall Study | Study terminated by sponsor | 0 | 0 | 1 |
| Overall Study | Treatment non-compliance | 5 | 0 | 8 |
| Overall Study | Withdrawal by Subject | 13 | 4 | 16 |
Baseline characteristics
| Characteristic | Placebo Followed by Olmesartan | Total | Losartan | Olmesartan |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 82 Participants | 46 Participants | 35 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 859 Participants | 423 Participants | 385 Participants |
| Age Continuous | 49.9 years STANDARD_DEVIATION 8.67 | 51.9 years STANDARD_DEVIATION 9.74 | 52.1 years STANDARD_DEVIATION 9.76 | 52.0 years STANDARD_DEVIATION 9.84 |
| Body Mass Index | 33.62 kilogram/meter^2 STANDARD_DEVIATION 8.103 | 32.41 kilogram/meter^2 STANDARD_DEVIATION 6.48 | 32.28 kilogram/meter^2 STANDARD_DEVIATION 6.619 | 32.41 kilogram/meter^2 STANDARD_DEVIATION 6.089 |
| Diastolic Blood Pressure | 100.8 mmHg STANDARD_DEVIATION 3.79 | 101.2 mmHg STANDARD_DEVIATION 4.09 | 101.3 mmHg STANDARD_DEVIATION 4.14 | 101.1 mmHg STANDARD_DEVIATION 4.07 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 120 Participants | 61 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 821 Participants | 408 Participants | 368 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 169.46 centimeter STANDARD_DEVIATION 9.652 | 170.17 centimeter STANDARD_DEVIATION 9.767 | 170.47 centimeter STANDARD_DEVIATION 9.906 | 169.92 centimeter STANDARD_DEVIATION 9.635 |
| Hypertension stage Stage I | 23 participants | 277 participants | 134 participants | 120 participants |
| Hypertension stage Stage II | 29 participants | 664 participants | 335 participants | 300 participants |
| Pulse Rate | 81.9 beats per minute STANDARD_DEVIATION 9.88 | 78.9 beats per minute STANDARD_DEVIATION 10.94 | 78.5 beats per minute STANDARD_DEVIATION 10.59 | 78.8 beats per minute STANDARD_DEVIATION 11.41 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 6 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 53 Participants | 26 Participants | 25 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 267 Participants | 133 Participants | 118 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 33 Participants | 610 Participants | 304 Participants | 273 Participants |
| Sex: Female, Male Female | 27 Participants | 428 Participants | 211 Participants | 190 Participants |
| Sex: Female, Male Male | 25 Participants | 513 Participants | 258 Participants | 230 Participants |
| Systolic Blood Pressure | 157.9 mmHg STANDARD_DEVIATION 10.05 | 158.3 mmHg STANDARD_DEVIATION 10.29 | 158.3 mmHg STANDARD_DEVIATION 10.24 | 158.3 mmHg STANDARD_DEVIATION 10.41 |
| Weight | 96.14 kilogram STANDARD_DEVIATION 22.611 | 94.01 kilogram STANDARD_DEVIATION 20.81 | 94.02 kilogram STANDARD_DEVIATION 21.647 | 93.73 kilogram STANDARD_DEVIATION 19.627 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 133 / 420 | 21 / 52 | 148 / 469 |
| serious Total, serious adverse events | 0 / 420 | 0 / 52 | 4 / 469 |
Outcome results
Primary
Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
The change from baseline in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.
Time frame: Day 0, Week 8
Population: The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Olmesartan | Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | -9.8 mmHg | Standard Error 0.5 |
| Combined Olmesartan | Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | -9.7 mmHg | Standard Error 0.45 |
| Losartan | Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | -7.1 mmHg | Standard Error 0.45 |
Comparison: Null hypothesis was that there was no difference in change in seated diastolic blood pressure from baseline to end of treatment. Sample size of 900, this study had 90% power to detect a true difference in mean change from baseline in mean trough SDBP of 2.0 mmHg for Combined Olmesartan vs Losartan.p-value: <0.000195% CI: [-3.8, -1.3]ANCOVA
Secondary
Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
The change from baseline in trough SDBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.
Time frame: Day 0, Week 4
Population: The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Olmesartan | Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | -9.0 mmHg | Standard Error 0.44 |
| Combined Olmesartan | Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | -8.8 mmHg | Standard Error 0.42 |
| Losartan | Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | -6.2 mmHg | Standard Error 0.42 |
p-value: <0.000195% CI: [-3.8, -1.5]ANCOVA
Secondary
Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
The change from baseline in trough SSBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.
Time frame: Day 0, Week 4
Population: The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Olmesartan | Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | -12.3 mmHg | Standard Error 0.67 |
| Combined Olmesartan | Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | -12.0 mmHg | Standard Error 0.64 |
| Losartan | Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | -8.5 mmHg | Standard Error 0.64 |
p-value: <0.000195% CI: [-5.3, -1.8]ANCOVA
Secondary
Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
The change from baseline in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.
Time frame: Day 0, Week 8
Population: The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Olmesartan | Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | -13.6 mmHg | Standard Error 0.75 |
| Combined Olmesartan | Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | -13.6 mmHg | Standard Error 0.71 |
| Losartan | Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | -9.7 mmHg | Standard Error 0.71 |
p-value: 0.000195% CI: [-5.8, -1.9]ANCOVA
Other Pre-specified
Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4
In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours.
Time frame: Baseline, Week 4
Population: The ABPM population was defined as all participants in the efficacy population that had valid (technically successful required at least 23 hours of ABPM data) baseline and Week 4 ABPM data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Olmesartan | Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4 | Systolic blood pressure | -7.3 mmHg | Standard Error 1.08 |
| Olmesartan | Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4 | Diastolic blood pressure | -4.9 mmHg | Standard Error 0.7 |
| Combined Olmesartan | Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4 | Systolic blood pressure | -7.3 mmHg | Standard Error 1.03 |
| Combined Olmesartan | Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4 | Diastolic blood pressure | -4.8 mmHg | Standard Error 0.67 |
| Losartan | Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4 | Systolic blood pressure | -5.9 mmHg | Standard Error 1.03 |
| Losartan | Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4 | Diastolic blood pressure | -3.7 mmHg | Standard Error 0.67 |
Comparison: Change from baseline at week 4 in systolic blood pressure.p-value: 0.32595% CI: [-4.4, 1.5]ANCOVA
Comparison: Change from baseline at week 4 in systolic blood pressure.p-value: 0.349195% CI: [-4.4, 1.5]ANCOVA
Comparison: Change from baseline at week 4 in diastolic blood pressure.p-value: 0.208595% CI: [-3.2, 0.7]ANCOVA
Comparison: Change from baseline at week 4 in diastolic blood pressure.p-value: 0.254295% CI: [-3, 0.8]ANCOVA
Other Pre-specified
Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8
In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours.
Time frame: Baseline, Week 8
Population: The ABPM population was defined as all participants in the efficacy population that had valid (technically successful required at least 23 hours of ABPM data) baseline and Week 8 ABPM data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Olmesartan | Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8 | Systolic blood pressure | -9.1 mmHg | Standard Error 1.16 |
| Olmesartan | Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8 | Diastolic blood pressure | -6.1 mmHg | Standard Error 0.78 |
| Combined Olmesartan | Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8 | Systolic blood pressure | -9.2 mmHg | Standard Error 1.11 |
| Combined Olmesartan | Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8 | Diastolic blood pressure | -6.1 mmHg | Standard Error 0.75 |
| Losartan | Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8 | Systolic blood pressure | -5.6 mmHg | Standard Error 1.09 |
| Losartan | Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8 | Diastolic blood pressure | -3.6 mmHg | Standard Error 0.73 |
Comparison: Change from baseline at week 8 in systolic blood pressure.p-value: 0.020995% CI: [-6.6, -0.5]ANCOVA
Comparison: Change from baseline at week 8 in systolic blood pressure.p-value: 0.018695% CI: [-6.6, -0.6]ANCOVA
Comparison: Change from baseline at week 8 in diastolic blood pressure.p-value: 0.017595% CI: [-4.5, -0.4]ANCOVA
Comparison: Change from baseline at week 8 in diastolic blood pressure.p-value: 0.017795% CI: [-4.4, -0.4]ANCOVA
Other Pre-specified
Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4
In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized.
Time frame: Baseline, Week 4
Population: The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 4 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 | 2 hour systolic blood pressure | -8.7 mmHg | Standard Error 1.31 |
| Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 | 2 hour diastolic blood pressure | -5.8 mmHg | Standard Error 0.94 |
| Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 | 4 hour systolic blood pressure | -8.4 mmHg | Standard Error 1.23 |
| Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 | 4 hour diastolic blood pressure | -5.8 mmHg | Standard Error 0.85 |
| Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 | 6 hour systolic blood pressure | -8.0 mmHg | Standard Error 1.18 |
| Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 | 6 hour diastolic blood pressure | -5.5 mmHg | Standard Error 0.83 |
| Combined Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 | 6 hour diastolic blood pressure | -5.4 mmHg | Standard Error 0.79 |
| Combined Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 | 2 hour systolic blood pressure | -8.4 mmHg | Standard Error 1.26 |
| Combined Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 | 4 hour diastolic blood pressure | -5.6 mmHg | Standard Error 0.82 |
| Combined Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 | 6 hour systolic blood pressure | -8.0 mmHg | Standard Error 1.13 |
| Combined Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 | 2 hour diastolic blood pressure | -5.6 mmHg | Standard Error 0.9 |
| Combined Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 | 4 hour systolic blood pressure | -8.3 mmHg | Standard Error 1.18 |
| Losartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 | 2 hour diastolic blood pressure | -3.8 mmHg | Standard Error 0.9 |
| Losartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 | 4 hour systolic blood pressure | -6.5 mmHg | Standard Error 1.18 |
| Losartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 | 6 hour diastolic blood pressure | -3.9 mmHg | Standard Error 0.79 |
| Losartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 | 4 hour diastolic blood pressure | -4.1 mmHg | Standard Error 0.82 |
| Losartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 | 2 hour systolic blood pressure | -6.8 mmHg | Standard Error 1.26 |
| Losartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4 | 6 hour systolic blood pressure | -6.2 mmHg | Standard Error 1.13 |
Comparison: 2 hour systolic blood pressurep-value: 0.322995% CI: [-5.4, 1.8]ANCOVA
Comparison: 2 hour systolic blood pressurep-value: 0.386395% CI: [-5.1, 2]ANCOVA
Comparison: 2 hour diastolic blood pressurep-value: 0.127795% CI: [-4.5, 0.6]ANCOVA
Comparison: 2 hour diastolic blood pressurep-value: 0.179995% CI: [-4.3, 0.8]ANCOVA
Comparison: 4 hour systolic blood pressurep-value: 0.270895% CI: [-5.1, 1.4]ANCOVA
Comparison: 4 hour systolic blood pressurep-value: 0.313395% CI: [-5, 1.6]ANCOVA
Comparison: 4 hour diastolic blood pressurep-value: 0.162195% CI: [-3.9, 0.7]ANCOVA
Comparison: 4 hour diastolic blood pressurep-value: 0.231495% CI: [-3.7, 0.9]ANCOVA
Comparison: 6 hour systolic blood pressurep-value: 0.246195% CI: [-5, 1.3]ANCOVA
Comparison: 6 hour systolic blood pressurep-value: 0.255895% CI: [-5, 1.3]ANCOVA
Comparison: 6 hour diastolic blood pressurep-value: 0.1795% CI: [-3.8, 0.7]ANCOVA
Comparison: 6 hour diastolic blood pressurep-value: 0.201195% CI: [-3.7, 0.8]ANCOVA
Other Pre-specified
Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8
In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized.
Time frame: Baseline, Week 8
Population: The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 8 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 | 2 hour systolic blood pressure | -10.0 mmHg | Standard Error 1.56 |
| Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 | 2 hour diastolic blood pressure | -6.3 mmHg | Standard Error 1.1 |
| Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 | 4 hour systolic blood pressure | -10.5 mmHg | Standard Error 1.4 |
| Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 | 4 hour diastolic blood pressure | -7.1 mmHg | Standard Error 0.96 |
| Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 | 6 hour systolic blood pressure | -10.0 mmHg | Standard Error 1.33 |
| Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 | 6 hour diastolic blood pressure | -6.8 mmHg | Standard Error 0.92 |
| Combined Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 | 6 hour diastolic blood pressure | -6.5 mmHg | Standard Error 0.89 |
| Combined Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 | 2 hour systolic blood pressure | -9.5 mmHg | Standard Error 1.5 |
| Combined Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 | 4 hour diastolic blood pressure | -6.7 mmHg | Standard Error 0.93 |
| Combined Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 | 6 hour systolic blood pressure | -9.7 mmHg | Standard Error 1.28 |
| Combined Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 | 2 hour diastolic blood pressure | -6.0 mmHg | Standard Error 1.06 |
| Combined Olmesartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 | 4 hour systolic blood pressure | -10.1 mmHg | Standard Error 1.35 |
| Losartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 | 2 hour diastolic blood pressure | -4.0 mmHg | Standard Error 1.04 |
| Losartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 | 4 hour systolic blood pressure | -6.9 mmHg | Standard Error 1.32 |
| Losartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 | 6 hour diastolic blood pressure | -4.0 mmHg | Standard Error 0.87 |
| Losartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 | 4 hour diastolic blood pressure | -4.1 mmHg | Standard Error 0.91 |
| Losartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 | 2 hour systolic blood pressure | -7.2 mmHg | Standard Error 1.48 |
| Losartan | Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8 | 6 hour systolic blood pressure | -6.5 mmHg | Standard Error 1.25 |
Comparison: 2 hour systolic blood pressurep-value: 0.189595% CI: [-7, 1.4]ANCOVA
Comparison: 2 hour systolic blood pressurep-value: 0.270195% CI: [-6.5, 1.8]ANCOVA
Comparison: 2 hour diastolic blood pressurep-value: 0.132895% CI: [-5.2, 0.7]ANCOVA
Comparison: 2 hour diastolic blood pressurep-value: 0.177895% CI: [-4.9, 0.9]ANCOVA
Comparison: 4 hour systolic blood pressurep-value: 0.06295% CI: [-7.3, 0.2]ANCOVA
Comparison: 4 hour systolic blood pressurep-value: 0.101195% CI: [-6.9, 0.6]ANCOVA
Comparison: 4 hour diastolic blood pressurep-value: 0.024995% CI: [-5.6, -0.4]ANCOVA
Comparison: 4 hour diastolic blood pressurep-value: 0.049795% CI: [-5.2, 0]ANCOVA
Comparison: 6 hour systolic blood pressurep-value: 0.055295% CI: [-7.1, 0.1]ANCOVA
Comparison: 6 hour systolic blood pressurep-value: 0.076795% CI: [-6.8, 0.3]ANCOVA
Comparison: 6 hour diastolic blood pressurep-value: 0.027995% CI: [-5.3, -0.3]ANCOVA
Comparison: 6 hour diastolic blood pressurep-value: 0.043495% CI: [-5, -0.1]ANCOVA
Other Pre-specified
Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4
In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized.
Time frame: Baseline, Week 4
Population: The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 4 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Olmesartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4 | Daytime systolic blood pressure | -7.6 mmHg | Standard Error 1.27 |
| Olmesartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4 | Daytime diastolic blood pressure | -5.4 mmHg | Standard Error 0.84 |
| Olmesartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4 | Nighttime systolic blood pressure | -6.7 mmHg | Standard Error 1.15 |
| Olmesartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4 | Nighttime diastolic blood pressure | -4.4 mmHg | Standard Error 0.77 |
| Combined Olmesartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4 | Nighttime diastolic blood pressure | -4.3 mmHg | Standard Error 0.74 |
| Combined Olmesartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4 | Daytime systolic blood pressure | -7.5 mmHg | Standard Error 1.22 |
| Combined Olmesartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4 | Nighttime systolic blood pressure | -6.8 mmHg | Standard Error 1.1 |
| Combined Olmesartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4 | Daytime diastolic blood pressure | -5.2 mmHg | Standard Error 0.81 |
| Losartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4 | Nighttime diastolic blood pressure | -3.4 mmHg | Standard Error 0.74 |
| Losartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4 | Daytime diastolic blood pressure | -3.5 mmHg | Standard Error 0.81 |
| Losartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4 | Nighttime systolic blood pressure | -5.5 mmHg | Standard Error 1.1 |
| Losartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4 | Daytime systolic blood pressure | -5.8 mmHg | Standard Error 1.22 |
Comparison: Daytime systolic blood pressurep-value: 0.310495% CI: [-5.2, 1.7]ANCOVA
Comparison: Daytime systolic blood pressurep-value: 0.365395% CI: [-4.9, 1.8]ANCOVA
Comparison: Daytime diastolic blood pressurep-value: 0.119795% CI: [-4.1, 0.5]ANCOVA
Comparison: Daytime diastolic blood pressurep-value: 0.165495% CI: [-3.9, 0.7]ANCOVA
Comparison: Nighttime systolic blood pressurep-value: 0.436295% CI: [-4.4, 1.9]ANCOVA
Comparison: Nighttime systolic blood pressurep-value: 0.403995% CI: [-4.5, 1.8]ANCOVA
Comparison: Nighttime diastolic blood pressurep-value: 0.392995% CI: [-3.1, 1.2]ANCOVA
Comparison: Nighttime diastolic blood pressurep-value: 0.425995% CI: [-3, 1.3]ANCOVA
Other Pre-specified
Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8
In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized.
Time frame: Baseline, Week 8
Population: The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 8 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Olmesartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8 | Daytime systolic blood pressure | -8.7 mmHg | Standard Error 1.24 |
| Olmesartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8 | Daytime diastolic blood pressure | -6.2 mmHg | Standard Error 0.86 |
| Olmesartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8 | Nighttime systolic blood pressure | -9.3 mmHg | Standard Error 1.32 |
| Olmesartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8 | Nighttime diastolic blood pressure | -6.2 mmHg | Standard Error 0.91 |
| Combined Olmesartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8 | Nighttime diastolic blood pressure | -6.1 mmHg | Standard Error 0.87 |
| Combined Olmesartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8 | Daytime systolic blood pressure | -8.7 mmHg | Standard Error 1.2 |
| Combined Olmesartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8 | Nighttime systolic blood pressure | -9.3 mmHg | Standard Error 1.27 |
| Combined Olmesartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8 | Daytime diastolic blood pressure | -6.1 mmHg | Standard Error 0.83 |
| Losartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8 | Nighttime diastolic blood pressure | -4.1 mmHg | Standard Error 0.86 |
| Losartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8 | Daytime diastolic blood pressure | -3.7 mmHg | Standard Error 0.82 |
| Losartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8 | Nighttime systolic blood pressure | -6.3 mmHg | Standard Error 1.25 |
| Losartan | Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8 | Daytime systolic blood pressure | -5.2 mmHg | Standard Error 1.17 |
Comparison: Daytime systolic blood pressurep-value: 0.039695% CI: [-6.8, -0.2]ANCOVA
Comparison: Daytime systolic blood pressurep-value: 0.034595% CI: [-6.8, -0.3]ANCOVA
Comparison: Daytime diastolic blood pressurep-value: 0.032495% CI: [-4.8, -0.2]ANCOVA
Comparison: Daytime diastolic blood pressurep-value: 0.036395% CI: [-4.7, -0.2]ANCOVA
Comparison: Nighttime systolic blood pressurep-value: 0.098895% CI: [-6.5, 0.6]ANCOVA
Comparison: Nighttime systolic blood pressurep-value: 0.092695% CI: [-6.4, 0.5]ANCOVA
Comparison: Nighttime diastolic blood pressurep-value: 0.0995% CI: [-4.5, 0.3]ANCOVA
Comparison: Nighttime diastolic blood pressurep-value: 0.094295% CI: [-4.4, 0.3]ANCOVA
Other Pre-specified
Change From Baseline to Week 2 in Trough, Cuff, Seated Blood Pressure
The change from baseline in trough systolic and diastolic blood pressure at Week 2 as measured by the Omron monitor. Morning doses of study medication were taken after the exam, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.
Time frame: Baseline, Week 2
Population: The efficacy population was defined as participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Olmesartan | Change From Baseline to Week 2 in Trough, Cuff, Seated Blood Pressure | Diastolic blood pressure | -8.3 mmHg | Standard Error 0.42 |
| Olmesartan | Change From Baseline to Week 2 in Trough, Cuff, Seated Blood Pressure | Systolic blood pressure | -11.9 mmHg | Standard Error 0.65 |
| Combined Olmesartan | Change From Baseline to Week 2 in Trough, Cuff, Seated Blood Pressure | Diastolic blood pressure | -4.0 mmHg | Standard Error 1.22 |
| Combined Olmesartan | Change From Baseline to Week 2 in Trough, Cuff, Seated Blood Pressure | Systolic blood pressure | -3.3 mmHg | Standard Error 1.87 |
Comparison: Diastolic blood pressurep-value: 0.000995% CI: [-6.8, -1.8]ANCOVA
Comparison: Systolic blood pressurep-value: <0.000195% CI: [-12.5, -4.7]ANCOVA
Other Pre-specified
Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)
The change from Week 4 in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.
Time frame: Week 4, Week 8
Population: The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Olmesartan | Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | -0.8 mmHg | Standard Error 0.4 |
| Combined Olmesartan | Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | -0.9 mmHg | Standard Error 0.38 |
| Losartan | Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP) | 0.0 mmHg | Standard Error 0.38 |
p-value: 0.112195% CI: [-2, 0.2]ANCOVA
p-value: 0.078395% CI: [-2, 0.1]ANCOVA
Other Pre-specified
Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)
The change from Week 4 in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.
Time frame: Week 4, Week 8
Population: The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Olmesartan | Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | -1.1 mmHg | Standard Error 0.66 |
| Combined Olmesartan | Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | -1.4 mmHg | Standard Error 0.63 |
| Losartan | Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP) | 0.0 mmHg | Standard Error 0.63 |
p-value: 0.231295% CI: [-2.9, 0.7]ANCOVA
p-value: 0.097995% CI: [-3.2, 0.3]ANCOVA
Post Hoc
Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8
Participants from pre-selected sites had 24-hour ambulatory blood pressure readings collected. Daytime readings were results collected between 8am and 4pm. Nighttime readings were results collected between 10pm and 6am.
Time frame: Week 8
Population: Ambulatory Blood Pressure Monitoring (ABPM) Population: All participants in the Efficacy Population that had both valid (technically successful) baseline and Week 8 ambulatory blood pressure monitor data. A technically successful ABPM had at least 23 hours of ABPM data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olmesartan | Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8 | Mean Nighttime | 76.5 percentage of population |
| Olmesartan | Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8 | Mean Daytime | 32.7 percentage of population |
| Olmesartan | Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8 | Mean 24-hour | 59.2 percentage of population |
| Combined Olmesartan | Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8 | Mean Nighttime | 77.4 percentage of population |
| Combined Olmesartan | Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8 | Mean 24-hour | 58.5 percentage of population |
| Combined Olmesartan | Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8 | Mean Daytime | 32.1 percentage of population |
| Losartan | Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8 | Mean Daytime | 21.8 percentage of population |
| Losartan | Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8 | Mean 24-hour | 40.9 percentage of population |
| Losartan | Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8 | Mean Nighttime | 66.4 percentage of population |
Other Pre-specified
Percentage of Participants Achieving Blood Pressure Goals at Week 4
Percentage of participants who achieved the following goals: Systolic blood pressure: \<140 mmHg, \<135 mmHg, \<130 mmHg, \<120 mmHg Diastolic blood pressure: \<90 mmHg, \<85 mmHg, \<80 mmHg Blood pressure: \<140/90 mmHg, \<135/80 mmHg, \<130/80 mmHg
Time frame: Week 4
Population: Efficacy population. Last observation carried forward. Denominator is the number of participants who have seated cuff BP measurement in each treatment group at any visit during the entire randomized treatment phase. Participants randomized to placebo-olmesartan, the measurement is after at least one dose of olmesartan.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Systolic BP <140 mmHg | 37.9 percentage of participants analyzed |
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Systolic BP <135 mmHg | 28.1 percentage of participants analyzed |
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Systolic BP <130 mmHg | 16.8 percentage of participants analyzed |
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Systolic BP <120 mmHg | 3.1 percentage of participants analyzed |
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Diastolic BP <90 mmHg | 39.6 percentage of participants analyzed |
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Diastolic BP <85 mmHg | 24.2 percentage of participants analyzed |
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Diastolic BP <80 mmHg | 10.6 percentage of participants analyzed |
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Blood pressure <140/90 mmHg | 27.3 percentage of participants analyzed |
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Blood pressure <135/80 mmHg | 7.4 percentage of participants analyzed |
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Blood pressure <130/80 mmHg | 5.5 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Blood pressure <135/80 mmHg | 7.6 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Systolic BP <140 mmHg | 36.7 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Diastolic BP <85 mmHg | 23.9 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Diastolic BP <90 mmHg | 38.8 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Systolic BP <135 mmHg | 27.1 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Blood pressure <130/80 mmHg | 5.9 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Blood pressure <140/90 mmHg | 26.5 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Systolic BP <130 mmHg | 16.5 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Diastolic BP <80 mmHg | 10.4 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Systolic BP <120 mmHg | 3.5 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Blood pressure <140/90 mmHg | 14.3 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Systolic BP <120 mmHg | 2.0 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Diastolic BP <90 mmHg | 24.5 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Diastolic BP <85 mmHg | 13.0 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Blood pressure <135/80 mmHg | 2.2 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Diastolic BP <80 mmHg | 4.6 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Systolic BP <140 mmHg | 25.6 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Blood pressure <130/80 mmHg | 1.5 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Systolic BP <135 mmHg | 14.1 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 4 | Systolic BP <130 mmHg | 7.2 percentage of participants analyzed |
Comparison: Percentage of participants achieving systolic blood pressure goal of \<140 mmHgp-value: <0.0001Regression, Logistic
Comparison: Percentage of participants achieving systolic blood pressure goal of \<140 mmHgp-value: 0.0001Regression, Logistic
Comparison: Percentage of participants achieving systolic blood pressure goal of \<135 mmHgp-value: <0.0001Regression, Logistic
Comparison: Percentage of participants achieving systolic blood pressure goal of \<135 mmHgp-value: <0.0001Regression, Logistic
Comparison: Percentage of participants achieving systolic blood pressure goal of \<130 mmHgp-value: <0.0001Regression, Logistic
Comparison: Percentage of participants achieving systolic blood pressure goal of \<130 mmHgp-value: <0.0001Regression, Logistic
Comparison: Percentage of participants achieving systolic blood pressure goal of \<120 mmHgp-value: 0.2755Regression, Logistic
Comparison: Percentage of participants achieving systolic blood pressure goal of \<120 mmHgp-value: 0.1646Regression, Logistic
Comparison: Percentage of participants achieving diastolic blood pressure goal of \<90 mmHgp-value: <0.0001Regression, Logistic
Comparison: Percentage of participants achieving diastolic blood pressure goal of \<90 mmHgp-value: <0.0001Regression, Logistic
Comparison: Percentage of participants achieving diastolic blood pressure goal of \<85 mmHgp-value: <0.0001Regression, Logistic
Comparison: Percentage of participants achieving diastolic blood pressure goal of \<85 mmHgp-value: <0.0001Regression, Logistic
Comparison: Percentage of participants achieving diastolic blood pressure goal of \<80 mmHgp-value: 0.001Regression, Logistic
Comparison: Percentage of participants achieving diastolic blood pressure goal of \<80 mmHgp-value: 0.0011Regression, Logistic
Comparison: Percentage of participants achieving blood pressure goal of \<140/90 mmHgp-value: <0.0001Regression, Logistic
Comparison: Percentage of participants achieving blood pressure goal of \<140/90 mmHgp-value: <0.0001Regression, Logistic
Comparison: Percentage of participants achieving blood pressure goal of \<135/80 mmHgp-value: 0.0005Regression, Logistic
Comparison: Percentage of participants achieving blood pressure goal of \<135/80 mmHgp-value: 0.0004Regression, Logistic
Comparison: Percentage of participants achieving blood pressure goal of \<130/80 mmHgp-value: 0.0023Regression, Logistic
Comparison: Percentage of participants achieving blood pressure goal of \<130/80 mmHgp-value: 0.0012Regression, Logistic
Other Pre-specified
Percentage of Participants Achieving Blood Pressure Goals at Week 8
Percentage of participants who achieved the following goals: Systolic blood pressure: \<140 mmHg, \<135 mmHg, \<130 mmHg, \<120 mmHg Diastolic blood pressure: \<90 mmHg, \<85 mmHg, \<80 mmHg Blood pressure: \<140/90 mmHg, \<135/80 mmHg, \<130/80 mmHg, \<120/80 mmHg
Time frame: Week 8
Population: Efficacy population. Last observation carried forward. Denominator is the number of participants who have seated cuff BP measurement in each treatment group at any visit during the entire randomized treatment phase. Participants randomized to placebo-olmesartan, the measurement is after at least one dose of olmesartan.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Blood pressure <140/90 mmHg | 32.6 percentage of participants analyzed |
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Diastolic BP <90 mmHg | 43.2 percentage of participants analyzed |
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Blood pressure <130/80 mmHg | 7.6 percentage of participants analyzed |
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Diastolic BP <80 mmHg | 12.2 percentage of participants analyzed |
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Diastolic BP <85 mmHg | 22.9 percentage of participants analyzed |
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Systolic BP <140 mmHg | 41.1 percentage of participants analyzed |
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Systolic BP <130 mmHg | 18.2 percentage of participants analyzed |
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Systolic BP <135 mmHg | 29.9 percentage of participants analyzed |
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Blood pressure <135/80 mmHg | 10.2 percentage of participants analyzed |
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Systolic BP <120 mmHg | 6.8 percentage of participants analyzed |
| Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Blood pressure <120/80 mmHg | 4.9 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Diastolic BP <85 mmHg | 22.9 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Systolic BP <140 mmHg | 41.0 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Systolic BP <135 mmHg | 30.0 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Systolic BP <130 mmHg | 18.4 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Systolic BP <120 mmHg | 6.6 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Diastolic BP <90 mmHg | 42.5 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Diastolic BP <80 mmHg | 11.8 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Blood pressure <140/90 mmHg | 31.6 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Blood pressure <135/80 mmHg | 9.9 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Blood pressure <130/80 mmHg | 7.5 percentage of participants analyzed |
| Combined Olmesartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Blood pressure <120/80 mmHg | 4.7 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Blood pressure <130/80 mmHg | 4.5 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Blood pressure <140/90 mmHg | 19.5 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Systolic BP <130 mmHg | 13.1 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Systolic BP <140 mmHg | 28.9 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Blood pressure <135/80 mmHg | 4.9 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Systolic BP <135 mmHg | 20.4 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Diastolic BP <85 mmHg | 15.5 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Diastolic BP <90 mmHg | 30.5 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Blood pressure <120/80 mmHg | 2.3 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Diastolic BP <80 mmHg | 6.6 percentage of participants analyzed |
| Losartan | Percentage of Participants Achieving Blood Pressure Goals at Week 8 | Systolic BP <120 mmHg | 3.8 percentage of participants analyzed |
Comparison: Percentage of participants achieving systolic blood pressure goal of \<140 mmHgp-value: <0.0001Regression, Logistic
Comparison: Percentage of participants achieving systolic blood pressure goal of \<140 mmHgp-value: <0.0001Regression, Logistic
Comparison: Percentage of participants achieving systolic blood pressure goal of \<135 mmHgp-value: 0.0009Regression, Logistic
Comparison: Percentage of participants achieving systolic blood pressure goal of \<135 mmHgp-value: 0.0007Regression, Logistic
Comparison: Percentage of participants achieving systolic blood pressure goal of \<130 mmHgp-value: 0.0347Regression, Logistic
Comparison: Percentage of participants achieving systolic blood pressure goal of \<130 mmHgp-value: 0.028Regression, Logistic
Comparison: Percentage of participants achieving systolic blood pressure goal of \<120 mmHgp-value: 0.0519Regression, Logistic
Comparison: Percentage of participants achieving systolic blood pressure goal of \<120 mmHgp-value: 0.0605Regression, Logistic
Comparison: Percentage of participants achieving diastolic blood pressure goal of \<90 mmHgp-value: 0.0001Regression, Logistic
Comparison: Percentage of participants achieving diastolic blood pressure goal of \<90 mmHgp-value: 0.0003Regression, Logistic
Comparison: Percentage of participants achieving diastolic blood pressure goal of \<85 mmHgp-value: 0.007Regression, Logistic
Comparison: Percentage of participants achieving diastolic blood pressure goal of \<85 mmHgp-value: 0.0066Regression, Logistic
Comparison: Percentage of participants achieving diastolic blood pressure goal of \<80 mmHgp-value: 0.0061Regression, Logistic
Comparison: Percentage of participants achieving diastolic blood pressure goal of \<80 mmHgp-value: 0.0096Regression, Logistic
Comparison: Percentage of participants achieving blood pressure goal of \<140/90 mmHgp-value: <0.0001Regression, Logistic
Comparison: Percentage of participants achieving blood pressure goal of \<140/90 mmHgp-value: <0.0001Regression, Logistic
Comparison: Percentage of participants achieving blood pressure goal of \<135/80 mmHgp-value: 0.0047Regression, Logistic
Comparison: Percentage of participants achieving blood pressure goal of \<135/80 mmHgp-value: 0.0063Regression, Logistic
Comparison: Percentage of participants achieving blood pressure goal of \<130/80 mmHgp-value: 0.0589Regression, Logistic
Comparison: Percentage of participants achieving blood pressure goal of \<130/80 mmHgp-value: 0.0594Regression, Logistic
Comparison: Percentage of participants achieving blood pressure goal of \<120/80 mmHgp-value: 0.0476Regression, Logistic
Comparison: Percentage of participants achieving blood pressure goal of \<120/80 mmHgp-value: 0.0657Regression, Logistic