Essential Hypertension
Conditions
Keywords
Hypertensive, Blood Pressure, High, Cardiovascular disease, Vascular Disease, Drug Therapy
Brief summary
The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil plus chlorthalidone, once daily (QD), to olmesartan medoxomil plus hydrochlorothiazide in participants with moderate to severe hypertension.
Detailed description
According to the World Health Organization, hypertension is the most common attributable cause of preventable death in developed nations, as uncontrolled hypertension greatly increases the risk of cardiovascular disease, cerebrovascular disease, and renal failure. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. Despite the availability of antihypertensive agents, hypertension remains inadequately controlled; only about one third of patients continue to maintain control successfully. Treatment algorithms for essential hypertension commonly include thiazides or thiazide-like diuretics, either alone or as part of combination treatment. Chlorthalidone is a commercially available, orally administered thiazide-type diuretic agent. TAK-491 (azilsartan medoxomil) is an angiotensin II receptor blocker developed by Takeda to treat participants with essential hypertension. This study will compare the safety and tolerability of azilsartan medoxomil plus chlorthalidone (TAK-491CLD) fixed-dose combination to olmesartan medoxomil plus hydrochlorothiazide fixed-dose combination.
Interventions
Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks. Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks. Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks.
Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks. Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks. Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Has a mean sitting clinic systolic blood pressure greater than or equal to 160 and less than or equal to 190 mm Hg. 2. Females of childbearing potential who are sexually active agree to routinely use adequate contraception from Screening through 30 days after the last administered study drug dose. 3. Has clinical laboratory test results within the reference range for the testing laboratory or the investigator does not consider the results to be clinically significant. 4. Is willing to discontinue current antihypertensive medications on Day -21 or Day -28 if the participant is on amlodipine or chlorthalidone.
Exclusion criteria
1. Has a mean sitting clinic diastolic blood pressure greater than 119 mm Hg on Day -1. 2. Has a baseline 24-hour ambulatory blood pressure monitoring reading of insufficient quality. 3. Works a night (third) shift. 4. Has an upper arm circumference less than 24 cm or greater than 42 cm. 5. Has secondary hypertension of any etiology. 6. Has a recent history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack. 7. Has clinically significant cardiac conduction defects. 8. Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease. 9. Has severe renal dysfunction or disease. 10. Has known or suspected unilateral or bilateral renal artery stenosis. 11. Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. 12. Has poorly-controlled diabetes mellitus at Screening. 13. Has hypokalemia or hyperkalemia. 14. Has an alanine aminotransferase or aspartate aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice. 15. Has any other known serious disease or condition that would compromise safety, might affect life expectancy, or make it difficult to successfully manage and follow the participant according to the protocol. 16. Has known hypersensitivity to angiotensin II receptor blockers or thiazide-type diuretics or other sulfonamide-derived compounds. 17. Has a history of drug abuse or a history of alcohol abuse within the past 2 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | Baseline and Week 12. | The change in sitting trough clinic systolic blood pressure measured at week 12 or final visit relative to baseline. Trough blood pressure is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure. | Baseline, Week 4, Week 8 and Week 12. | The change in sitting trough clinic diastolic blood pressure measured at each week indicated relative to baseline. Trough blood pressure is the average (arithmetic mean) of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements. |
| Change From Baseline in Mean Trough Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | The change in trough systolic blood pressure measured at week 12 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing. |
| Change From Baseline in Mean Trough Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | The change in trough diastolic blood pressure measured at week 12 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing. |
| Change From Baseline in 24-hour Mean Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | The change in 24-hour mean systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing. |
| Change From Baseline in 24-hour Mean Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | The change in 24-hour mean diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing. |
| Change From Baseline in Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive). |
| Change From Baseline in Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive). |
| Change From Baseline in Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | The change in the mean nighttime (12am to 6am) systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Mean nighttime is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive). |
| Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | Baseline, Week 4 and Week 8. | The change in sitting trough clinic systolic blood pressure measured at each week indicated relative to baseline. Trough blood pressure is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements. |
| Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | The change in the mean 12 hour systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements. |
| Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | The change in the mean 12 hour diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements. |
| Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | The change from baseline for each hour interval of the 24-hour ambulatory blood pressure monitoring measured at week 12 or final visit. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each hour. |
| Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | The change from baseline for each hour interval of the 24-hour ambulatory blood pressure monitoring measured at week 12 or final visit. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each hour. |
| Percentage of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline. | Baseline, Week 4, Week 8 and Week 12. | Percentage of participants who achieve a clinic systolic blood pressure response measured at each week indicated, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the non-missing values of the 3serial trough sitting systolic blood pressure measurements. |
| Percentage of Participants Who Reached Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline. | Baseline, Week 4, Week 8 and Week 12. | Percentage of participants who achieve a clinic diastolic blood pressure response measured at each week indicated, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the non-missing values of the 3 serial trough sitting diastolic blood pressure measurements. |
| Percent of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline and Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline. | Baseline, Week 4, Week 8 and Week 12. | Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at each week indicated, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the non-missing values of the 3 serial trough sitting blood pressure measurements. |
| Change From Baseline in Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | Baseline and Week 12. | The change in the mean nighttime (12am to 6am) diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Mean nighttime is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive). |
Countries
Canada, United States
Participant flow
Recruitment details
Participants enrolled at 130 investigative sites in Canada and the United States from 08 December 2009 to 04 November 2010.
Pre-assignment details
Participants with essential hypertension were enrolled in one of three, once-daily (QD) treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks. | 355 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks. | 352 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.
Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.
Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks. | 364 |
| Total | 1,071 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 28 | 51 | 26 |
| Overall Study | Lack of Efficacy | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 4 | 5 | 5 |
| Overall Study | Other | 6 | 4 | 3 |
| Overall Study | Protocol Violation | 0 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 17 | 14 | 11 |
Baseline characteristics
| Characteristic | Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Total |
|---|---|---|---|---|
| Age Continuous | 56.4 years STANDARD_DEVIATION 10.49 | 56.7 years STANDARD_DEVIATION 10.07 | 56.7 years STANDARD_DEVIATION 10.86 | 56.6 years STANDARD_DEVIATION 10.47 |
| Age, Customized <45 years | 46 participants | 33 participants | 46 participants | 125 participants |
| Age, Customized ≥65 years | 74 participants | 78 participants | 84 participants | 236 participants |
| Age, Customized Between 45 to 64 years | 235 participants | 241 participants | 234 participants | 710 participants |
| Body Mass Index (BMI) | 31.4 kg/m2 STANDARD_DEVIATION 5.94 | 31.9 kg/m2 STANDARD_DEVIATION 6.59 | 31.6 kg/m2 STANDARD_DEVIATION 5.92 | 31.6 kg/m2 STANDARD_DEVIATION 6.15 |
| Estimated glomerular filtration rate (eGFR) ≥0 to <30 | 0 participants | 0 participants | 1 participants | 1 participants |
| Estimated glomerular filtration rate (eGFR) ≥30 to <60 | 26 participants | 29 participants | 25 participants | 80 participants |
| Estimated glomerular filtration rate (eGFR) ≥60 to <90 | 224 participants | 220 participants | 246 participants | 690 participants |
| Estimated glomerular filtration rate (eGFR) ≥90 | 105 participants | 103 participants | 91 participants | 299 participants |
| Estimated glomerular filtration rate (eGFR) Missing | 0 participants | 0 participants | 1 participants | 1 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 36 Participants | 34 Participants | 98 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 248 Participants | 241 Participants | 251 Participants | 740 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 79 Participants | 75 Participants | 79 Participants | 233 Participants |
| Height | 171.2 cm STANDARD_DEVIATION 10.15 | 169.3 cm STANDARD_DEVIATION 10.88 | 169.4 cm STANDARD_DEVIATION 10.15 | 170.0 cm STANDARD_DEVIATION 10.42 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 participants | 5 participants | 5 participants | 12 participants |
| Race (NIH/OMB) Asian | 13 participants | 11 participants | 11 participants | 35 participants |
| Race (NIH/OMB) Black or African American | 80 participants | 80 participants | 80 participants | 240 participants |
| Race (NIH/OMB) More than one race | 1 participants | 2 participants | 1 participants | 4 participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 participants | 1 participants | 2 participants | 3 participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 participants | 0 participants | 0 participants | 0 participants |
| Race (NIH/OMB) White | 261 participants | 258 participants | 267 participants | 786 participants |
| Region of Enrollment Canada | 79 participants | 75 participants | 79 participants | 233 participants |
| Region of Enrollment United States | 276 participants | 277 participants | 285 participants | 838 participants |
| Sex: Female, Male Female | 132 Participants | 151 Participants | 159 Participants | 442 Participants |
| Sex: Female, Male Male | 223 Participants | 201 Participants | 205 Participants | 629 Participants |
| Weight | 92.34 kg STANDARD_DEVIATION 20.296 | 91.47 kg STANDARD_DEVIATION 20.987 | 90.83 kg STANDARD_DEVIATION 18.59 | 91.54 kg STANDARD_DEVIATION 19.96 |
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 | 141 / 355 | 144 / 352 | 94 / 364 |
| serious Total, serious adverse events | 1 / 355 | 10 / 352 | 8 / 364 |
Outcome results
Primary
Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.
The change in sitting trough clinic systolic blood pressure measured at week 12 or final visit relative to baseline. Trough blood pressure is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.
Time frame: Baseline and Week 12.
Population: Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | -42.5 mmHg | Standard Error 0.81 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | -44.0 mmHg | Standard Error 0.83 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | -37.1 mmHg | Standard Error 0.8 |
Comparison: Analysis of covariance (ANCOVA) model with treatment group as a fixed effect and baseline value as a covariate.p-value: <0.00195% CI: [-7.6, -3.1]ANCOVA
Comparison: ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.p-value: <0.00195% CI: [-9.2, -4.6]ANCOVA
Secondary
Change From Baseline in 24-hour Mean Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
The change in 24-hour mean diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Time frame: Baseline and Week 12.
Population: Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in 24-hour Mean Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -19.4 mmHg | Standard Error 0.45 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in 24-hour Mean Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -20.7 mmHg | Standard Error 0.46 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in 24-hour Mean Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -16.2 mmHg | Standard Error 0.44 |
Secondary
Change From Baseline in 24-hour Mean Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
The change in 24-hour mean systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Time frame: Baseline and Week 12.
Population: Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in 24-hour Mean Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -33.9 mmHg | Standard Error 0.76 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in 24-hour Mean Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -36.3 mmHg | Standard Error 0.79 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in 24-hour Mean Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -27.5 mmHg | Standard Error 0.75 |
Comparison: ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.p-value: <0.00195% CI: [-8.5, -4.3]ANCOVA
Comparison: ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.p-value: <0.00195% CI: [-11, -6.7]ANCOVA
Secondary
Change From Baseline in Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive).
Time frame: Baseline and Week 12.
Population: Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -20.1 mmHg | Standard Error 0.48 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -21.8 mmHg | Standard Error 0.5 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -17.0 mmHg | Standard Error 0.47 |
Secondary
Change From Baseline in Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive).
Time frame: Baseline and Week 12.
Population: Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -35.3 mmHg | Standard Error 0.8 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -37.9 mmHg | Standard Error 0.84 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -28.8 mmHg | Standard Error 0.79 |
Secondary
Change From Baseline in Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
The change in the mean nighttime (12am to 6am) diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Mean nighttime is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive).
Time frame: Baseline and Week 12.
Population: Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -17.5 mmHg | Standard Error 0.48 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -18.0 mmHg | Standard Error 0.5 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -14.0 mmHg | Standard Error 0.48 |
Secondary
Change From Baseline in Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
The change in the mean nighttime (12am to 6am) systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Mean nighttime is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive).
Time frame: Baseline and Week 12.
Population: Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -29.6 mmHg | Standard Error 0.78 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -31.8 mmHg | Standard Error 0.81 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -23.9 mmHg | Standard Error 0.77 |
Secondary
Change From Baseline in Mean Trough Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
The change in trough diastolic blood pressure measured at week 12 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Time frame: Baseline and Week 12.
Population: Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Mean Trough Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -19.8 mmHg | Standard Error 0.55 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Mean Trough Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -20.2 mmHg | Standard Error 0.57 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in Mean Trough Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -16.0 mmHg | Standard Error 0.54 |
Secondary
Change From Baseline in Mean Trough Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.
The change in trough systolic blood pressure measured at week 12 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Time frame: Baseline and Week 12.
Population: Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Mean Trough Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -32.9 mmHg | Standard Error 0.86 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Mean Trough Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -34.9 mmHg | Standard Error 0.9 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in Mean Trough Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring. | -25.9 mmHg | Standard Error 0.85 |
Comparison: ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.p-value: <0.00195% CI: [-9.4, -4.7]ANCOVA
Comparison: ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.p-value: <0.00195% CI: [-11.5, -6.6]ANCOVA
Secondary
Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring.
The change in the mean 12 hour diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements.
Time frame: Baseline and Week 12.
Population: Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring. | -20.4 mmHg | Standard Error 0.51 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring. | -22.2 mmHg | Standard Error 0.53 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring. | -17.5 mmHg | Standard Error 0.5 |
Secondary
Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring.
The change from baseline for each hour interval of the 24-hour ambulatory blood pressure monitoring measured at week 12 or final visit. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each hour.
Time frame: Baseline and Week 12.
Population: Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 13 to 14 Hour (n=232; n=214; n=238) | -19.6 mmHg | Standard Error 0.72 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 4 to 5 Hour (n=232; n=214; n=238) | -21.7 mmHg | Standard Error 0.67 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 14 to 15 Hour (n=232; n=214; n=238) | -18.9 mmHg | Standard Error 0.72 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 15 to 16 Hour (n=232; n=214; n=238) | -17.8 mmHg | Standard Error 0.65 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 5 to 6 Hour (n=232; n=214; n=238) | -20.9 mmHg | Standard Error 0.67 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 16 to 17 Hour (n=232; n=214; n=238) | -17.2 mmHg | Standard Error 0.65 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 20 to 21 Hour (n=232; n=214; n=238) | -16.7 mmHg | Standard Error 0.64 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 21 to 22 Hour (n=232; n=214; n=238) | -17.8 mmHg | Standard Error 0.66 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 1 to 2 Hour (n=232; n=214; n=238) | -18.8 mmHg | Standard Error 0.65 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 22 to 23 Hour (n=232; n=214; n=238) | -19.5 mmHg | Standard Error 0.62 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 6 to 7 Hour (n=232; n=214; n=238) | -20.8 mmHg | Standard Error 0.65 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 23 to 24 Hour (n=232; n=214; n=238) | -20.2 mmHg | Standard Error 0.6 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 18 to 19 Hour (n=232; n=214; n=238) | -17.4 mmHg | Standard Error 0.65 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 7 to 8 Hour (n=232; n=214; n=238) | -20.5 mmHg | Standard Error 0.66 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 17 to 18 Hour (n=231; n=214; n=238) | -16.6 mmHg | Standard Error 0.64 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 8 to 9 Hour (n=232; n=214; n=238) | -20.7 mmHg | Standard Error 0.67 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 2 to 3 Hour (n=232; n=214; n=238) | -21.2 mmHg | Standard Error 0.66 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 9 to 10 Hour (n=232; n=214; n=238) | -21.0 mmHg | Standard Error 0.66 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 10 to 11 Hour (n=232; n=214; n=238) | -19.7 mmHg | Standard Error 0.67 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 0 to 1 Hour (n=232; n=212; n=237) | -18.2 mmHg | Standard Error 0.59 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 11 to 12 Hour (n=232; n=214; n=238) | -19.3 mmHg | Standard Error 0.69 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 3 to 4 Hour (n=232; n=214; n=238) | -20.8 mmHg | Standard Error 0.69 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 19 to 20 Hour (n=232; n=214; n=238) | -17.8 mmHg | Standard Error 0.6 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 12 to 13 Hour (n=232; n=214; n=238) | -19.2 mmHg | Standard Error 0.73 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 10 to 11 Hour (n=232; n=214; n=238) | -20.7 mmHg | Standard Error 0.7 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 1 to 2 Hour (n=232; n=214; n=238) | -20.9 mmHg | Standard Error 0.67 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 0 to 1 Hour (n=232; n=212; n=237) | -20.4 mmHg | Standard Error 0.62 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 14 to 15 Hour (n=232; n=214; n=238) | -19.7 mmHg | Standard Error 0.75 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 19 to 20 Hour (n=232; n=214; n=238) | -18.5 mmHg | Standard Error 0.63 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 4 to 5 Hour (n=232; n=214; n=238) | -23.7 mmHg | Standard Error 0.7 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 7 to 8 Hour (n=232; n=214; n=238) | -21.9 mmHg | Standard Error 0.69 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 15 to 16 Hour (n=232; n=214; n=238) | -18.6 mmHg | Standard Error 0.68 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 17 to 18 Hour (n=231; n=214; n=238) | -17.1 mmHg | Standard Error 0.66 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 13 to 14 Hour (n=232; n=214; n=238) | -19.5 mmHg | Standard Error 0.75 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 18 to 19 Hour (n=232; n=214; n=238) | -18.1 mmHg | Standard Error 0.67 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 16 to 17 Hour (n=232; n=214; n=238) | -16.9 mmHg | Standard Error 0.68 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 8 to 9 Hour (n=232; n=214; n=238) | -21.5 mmHg | Standard Error 0.69 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 20 to 21 Hour (n=232; n=214; n=238) | -18.4 mmHg | Standard Error 0.67 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 5 to 6 Hour (n=232; n=214; n=238) | -23.6 mmHg | Standard Error 0.7 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 11 to 12 Hour (n=232; n=214; n=238) | -21.2 mmHg | Standard Error 0.72 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 21 to 22 Hour (n=232; n=214; n=238) | -18.5 mmHg | Standard Error 0.69 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 12 to 13 Hour (n=232; n=214; n=238) | -20.3 mmHg | Standard Error 0.76 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 9 to 10 Hour (n=232; n=214; n=238) | -21.9 mmHg | Standard Error 0.68 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 22 to 23 Hour (n=232; n=214; n=238) | -19.6 mmHg | Standard Error 0.65 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 2 to 3 Hour (n=232; n=214; n=238) | -23.4 mmHg | Standard Error 0.69 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 3 to 4 Hour (n=232; n=214; n=238) | -23.7 mmHg | Standard Error 0.72 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 23 to 24 Hour (n=232; n=214; n=238) | -21.0 mmHg | Standard Error 0.62 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 6 to 7 Hour (n=232; n=214; n=238) | -22.0 mmHg | Standard Error 0.67 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 23 to 24 Hour (n=232; n=214; n=238) | -16.4 mmHg | Standard Error 0.59 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 17 to 18 Hour (n=231; n=214; n=238) | -13.2 mmHg | Standard Error 0.63 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 0 to 1 Hour (n=232; n=212; n=237) | -15.2 mmHg | Standard Error 0.59 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 1 to 2 Hour (n=232; n=214; n=238) | -15.9 mmHg | Standard Error 0.64 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 2 to 3 Hour (n=232; n=214; n=238) | -17.7 mmHg | Standard Error 0.65 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 3 to 4 Hour (n=232; n=214; n=238) | -18.2 mmHg | Standard Error 0.68 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 4 to 5 Hour (n=232; n=214; n=238) | -17.9 mmHg | Standard Error 0.66 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 5 to 6 Hour (n=232; n=214; n=238) | -19.0 mmHg | Standard Error 0.66 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 6 to 7 Hour (n=232; n=214; n=238) | -18.0 mmHg | Standard Error 0.64 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 7 to 8 Hour (n=232; n=214; n=238) | -17.7 mmHg | Standard Error 0.65 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 8 to 9 Hour (n=232; n=214; n=238) | -17.9 mmHg | Standard Error 0.66 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 9 to 10 Hour (n=232; n=214; n=238) | -18.3 mmHg | Standard Error 0.65 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 10 to 11 Hour (n=232; n=214; n=238) | -16.7 mmHg | Standard Error 0.66 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 18 to 19 Hour (n=232; n=214; n=238) | -14.3 mmHg | Standard Error 0.64 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 11 to 12 Hour (n=232; n=214; n=238) | -17.0 mmHg | Standard Error 0.68 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 12 to 13 Hour (n=232; n=214; n=238) | -16.0 mmHg | Standard Error 0.72 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 13 to 14 Hour (n=232; n=214; n=238) | -15.3 mmHg | Standard Error 0.71 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 14 to 15 Hour (n=232; n=214; n=238) | -15.4 mmHg | Standard Error 0.71 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 15 to 16 Hour (n=232; n=214; n=238) | -14.5 mmHg | Standard Error 0.65 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 19 to 20 Hour (n=232; n=214; n=238) | -13.8 mmHg | Standard Error 0.6 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 20 to 21 Hour (n=232; n=214; n=238) | -13.9 mmHg | Standard Error 0.63 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 21 to 22 Hour (n=232; n=214; n=238) | -14.7 mmHg | Standard Error 0.65 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 22 to 23 Hour (n=232; n=214; n=238) | -15.6 mmHg | Standard Error 0.62 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 16 to 17 Hour (n=232; n=214; n=238) | -13.9 mmHg | Standard Error 0.64 |
Secondary
Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring.
The change in the mean 12 hour systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements.
Time frame: Baseline and Week 12.
Population: Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring. | -36.2 mmHg | Standard Error 0.86 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring. | -38.8 mmHg | Standard Error 0.89 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring. | -29.7 mmHg | Standard Error 0.85 |
Secondary
Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring.
The change from baseline for each hour interval of the 24-hour ambulatory blood pressure monitoring measured at week 12 or final visit. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each hour.
Time frame: Baseline and Week 12.
Population: Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 17 to 18 Hour (n=231; n=214; n=238) | -28.5 mmHg | Standard Error 0.93 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 2 to 3 Hour (n=232; n=214; n=238) | -36.7 mmHg | Standard Error 1.02 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 6 to 7 Hour (n=232; n=214; n=238) | -36.3 mmHg | Standard Error 1.04 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 0 to 1 Hour (n=232; n=212; n=237) | -33.6 mmHg | Standard Error 0.96 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 1 to 2 Hour (n=232; n=214; n=238) | -33.4 mmHg | Standard Error 0.98 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 3 to 4 Hour (n=232; n=214; n=238) | -36.6 mmHg | Standard Error 1.07 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 4 to 5 Hour (n=232; n=214; n=238) | -36.8 mmHg | Standard Error 1.07 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 5 to 6 Hour (n=232; n=214; n=238) | -37.2 mmHg | Standard Error 1.02 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 7 to 8 Hour (n=232; n=214; n=238) | -37.2 mmHg | Standard Error 1.02 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 8 to 9 Hour (n=232; n=214; n=238) | -37.3 mmHg | Standard Error 1.02 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 9 to 10 Hour (n=232; n=214; n=238) | -36.9 mmHg | Standard Error 0.99 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 10 to 11 Hour (n=232; n=214; n=238) | -36.1 mmHg | Standard Error 1.02 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 11 to 12 Hour (n=232; n=214; n=238) | -35.2 mmHg | Standard Error 1.01 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 12 to 13 Hour (n=232; n=214; n=238) | -34.8 mmHg | Standard Error 1.05 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 13 to 14 Hour (n=232; n=214; n=238) | -34.1 mmHg | Standard Error 1.06 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 14 to 15 Hour (n=232; n=214; n=238) | -33.4 mmHg | Standard Error 1.06 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 15 to 16 Hour (n=232; n=214; n=238) | -30.9 mmHg | Standard Error 0.99 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 16 to 17 Hour (n=232; n=214; n=238) | -29.6 mmHg | Standard Error 0.94 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 18 to 19 Hour (n=232; n=214; n=238) | -29.5 mmHg | Standard Error 0.9 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 19 to 20 Hour (n=232; n=214; n=238) | -29.7 mmHg | Standard Error 0.89 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 20 to 21 Hour (n=232; n=214; n=238) | -28.2 mmHg | Standard Error 0.94 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 21 to 22 Hour (n=232; n=214; n=238) | -30.6 mmHg | Standard Error 0.95 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 22 to 23 Hour (n=232; n=214; n=238) | -32.9 mmHg | Standard Error 0.94 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 23 to 24 Hour (n=232; n=214; n=238) | -33.1 mmHg | Standard Error 0.92 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 23 to 24 Hour (n=232; n=214; n=238) | -35.8 mmHg | Standard Error 0.96 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 7 to 8 Hour (n=232; n=214; n=238) | -38.5 mmHg | Standard Error 1.06 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 18 to 19 Hour (n=232; n=214; n=238) | -31.9 mmHg | Standard Error 0.94 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 8 to 9 Hour (n=232; n=214; n=238) | -38.1 mmHg | Standard Error 1.06 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 9 to 10 Hour (n=232; n=214; n=238) | -38.0 mmHg | Standard Error 1.04 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 22 to 23 Hour (n=232; n=214; n=238) | -34.0 mmHg | Standard Error 0.98 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 10 to 11 Hour (n=232; n=214; n=238) | -37.6 mmHg | Standard Error 1.06 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 19 to 20 Hour (n=232; n=214; n=238) | -32.5 mmHg | Standard Error 0.93 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 11 to 12 Hour (n=232; n=214; n=238) | -38.2 mmHg | Standard Error 1.05 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 12 to 13 Hour (n=232; n=214; n=238) | -36.2 mmHg | Standard Error 1.09 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 14 to 15 Hour (n=232; n=214; n=238) | -35.0 mmHg | Standard Error 1.1 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 21 to 22 Hour (n=232; n=214; n=238) | -32.8 mmHg | Standard Error 0.99 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 15 to 16 Hour (n=232; n=214; n=238) | -32.9 mmHg | Standard Error 1.03 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 2 to 3 Hour (n=232; n=214; n=238) | -39.3 mmHg | Standard Error 1.06 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 5 to 6 Hour (n=232; n=214; n=238) | -41.2 mmHg | Standard Error 1.06 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 13 to 14 Hour (n=232; n=214; n=238) | -35.3 mmHg | Standard Error 1.11 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 20 to 21 Hour (n=232; n=214; n=238) | -31.2 mmHg | Standard Error 0.98 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 16 to 17 Hour (n=232; n=214; n=238) | -31.1 mmHg | Standard Error 0.98 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 0 to 1 Hour (n=232; n=212; n=237) | -36.2 mmHg | Standard Error 1 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 1 to 2 Hour (n=232; n=214; n=238) | -36.4 mmHg | Standard Error 1.02 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 3 to 4 Hour (n=232; n=214; n=238) | -40.3 mmHg | Standard Error 1.12 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 17 to 18 Hour (n=231; n=214; n=238) | -30.8 mmHg | Standard Error 0.97 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 4 to 5 Hour (n=232; n=214; n=238) | -40.8 mmHg | Standard Error 1.11 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 6 to 7 Hour (n=232; n=214; n=238) | -38.6 mmHg | Standard Error 1.08 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 20 to 21 Hour (n=232; n=214; n=238) | -23.0 mmHg | Standard Error 0.92 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 1 to 2 Hour (n=232; n=214; n=238) | -27.5 mmHg | Standard Error 0.97 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 7 to 8 Hour (n=232; n=214; n=238) | -29.7 mmHg | Standard Error 1 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 15 to 16 Hour (n=232; n=214; n=238) | -25.3 mmHg | Standard Error 0.97 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 17 to 18 Hour (n=231; n=214; n=238) | -23.1 mmHg | Standard Error 0.92 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 8 to 9 Hour (n=232; n=214; n=238) | -30.5 mmHg | Standard Error 1.01 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 18 to 19 Hour (n=232; n=214; n=238) | -24.3 mmHg | Standard Error 0.89 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 2 to 3 Hour (n=232; n=214; n=238) | -30.0 mmHg | Standard Error 1 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 9 to 10 Hour (n=232; n=214; n=238) | -30.8 mmHg | Standard Error 0.98 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 3 to 4 Hour (n=232; n=214; n=238) | -29.6 mmHg | Standard Error 1.06 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 4 to 5 Hour (n=232; n=214; n=238) | -30.1 mmHg | Standard Error 1.06 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 10 to 11 Hour (n=232; n=214; n=238) | -29.4 mmHg | Standard Error 1.01 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 6 to 7 Hour (n=232; n=214; n=238) | -29.8 mmHg | Standard Error 1.02 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 5 to 6 Hour (n=232; n=214; n=238) | -31.5 mmHg | Standard Error 1 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 11 to 12 Hour (n=232; n=214; n=238) | -29.3 mmHg | Standard Error 1 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 19 to 20 Hour (n=232; n=214; n=238) | -23.5 mmHg | Standard Error 0.88 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 21 to 22 Hour (n=232; n=214; n=238) | -24.6 mmHg | Standard Error 0.93 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 12 to 13 Hour (n=232; n=214; n=238) | -27.7 mmHg | Standard Error 1.04 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 22 to 23 Hour (n=232; n=214; n=238) | -25.9 mmHg | Standard Error 0.92 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 13 to 14 Hour (n=232; n=214; n=238) | -26.4 mmHg | Standard Error 1.05 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 23 to 24 Hour (n=232; n=214; n=238) | -26.1 mmHg | Standard Error 0.91 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 0 to 1 Hour (n=232; n=212; n=237) | -26.8 mmHg | Standard Error 0.95 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 14 to 15 Hour (n=232; n=214; n=238) | -26.2 mmHg | Standard Error 1.04 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring. | 16 to 17 Hour (n=232; n=214; n=238) | -24.5 mmHg | Standard Error 0.93 |
Secondary
Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure.
The change in sitting trough clinic diastolic blood pressure measured at each week indicated relative to baseline. Trough blood pressure is the average (arithmetic mean) of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.
Time frame: Baseline, Week 4, Week 8 and Week 12.
Population: Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure. | Week 8 (n=344; n=330; n=353) | -17.0 mmHg | Standard Error 0.48 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure. | Week 4 (n=343; n=330; n=352) | -14.9 mmHg | Standard Error 0.46 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure. | Week 12 (n=344; n=330; n=354) | -18.8 mmHg | Standard Error 0.47 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure. | Week 8 (n=344; n=330; n=353) | -17.7 mmHg | Standard Error 0.49 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure. | Week 4 (n=343; n=330; n=352) | -15.8 mmHg | Standard Error 0.47 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure. | Week 12 (n=344; n=330; n=354) | -20.5 mmHg | Standard Error 0.48 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure. | Week 4 (n=343; n=330; n=352) | -11.7 mmHg | Standard Error 0.45 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure. | Week 12 (n=344; n=330; n=354) | -16.4 mmHg | Standard Error 0.46 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure. | Week 8 (n=344; n=330; n=353) | -13.9 mmHg | Standard Error 0.48 |
Secondary
Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.
The change in sitting trough clinic systolic blood pressure measured at each week indicated relative to baseline. Trough blood pressure is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.
Time frame: Baseline, Week 4 and Week 8.
Population: Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | Week 4 (n=343; n=330; n=352) | -34.7 mmHg | Standard Error 0.77 |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | Week 8 (n=344; n=330; n=353) | -39.1 mmHg | Standard Error 0.78 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | Week 4 (n=343; n=330; n=352) | -36.7 mmHg | Standard Error 0.79 |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | Week 8 (n=344; n=330; n=353) | -39.4 mmHg | Standard Error 0.8 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | Week 4 (n=343; n=330; n=352) | -29.7 mmHg | Standard Error 0.76 |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure. | Week 8 (n=344; n=330; n=353) | -33.5 mmHg | Standard Error 0.77 |
Secondary
Percentage of Participants Who Reached Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline.
Percentage of participants who achieve a clinic diastolic blood pressure response measured at each week indicated, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the non-missing values of the 3 serial trough sitting diastolic blood pressure measurements.
Time frame: Baseline, Week 4, Week 8 and Week 12.
Population: Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Percentage of Participants Who Reached Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline. | Week 12 (n=344; n=330; n=354) | 94.5 percentage of participants |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Percentage of Participants Who Reached Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline. | Week 8 (n=344; n=330; n=353) | 90.7 percentage of participants |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Percentage of Participants Who Reached Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline. | Week 4 (n=343; n=330; n=352) | 89.2 percentage of participants |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Percentage of Participants Who Reached Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline. | Week 12 (n=344; n=330; n=354) | 95.8 percentage of participants |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Percentage of Participants Who Reached Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline. | Week 4 (n=343; n=330; n=352) | 89.7 percentage of participants |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Percentage of Participants Who Reached Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline. | Week 8 (n=344; n=330; n=353) | 90.9 percentage of participants |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Percentage of Participants Who Reached Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline. | Week 8 (n=344; n=330; n=353) | 87.8 percentage of participants |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Percentage of Participants Who Reached Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline. | Week 4 (n=343; n=330; n=352) | 85.2 percentage of participants |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Percentage of Participants Who Reached Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline. | Week 12 (n=344; n=330; n=354) | 91.5 percentage of participants |
Secondary
Percentage of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline.
Percentage of participants who achieve a clinic systolic blood pressure response measured at each week indicated, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the non-missing values of the 3serial trough sitting systolic blood pressure measurements.
Time frame: Baseline, Week 4, Week 8 and Week 12.
Population: Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Percentage of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline. | Week 8 (n=344; n=330; n=353) | 93.3 percentage of participants |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Percentage of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline. | Week 4 (n=343; n=330; n=352) | 87.8 percentage of participants |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Percentage of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline. | Week 12 (n=344; n=330; n=354) | 93.0 percentage of participants |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Percentage of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline. | Week 8 (n=344; n=330; n=353) | 92.4 percentage of participants |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Percentage of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline. | Week 4 (n=343; n=330; n=352) | 90.0 percentage of participants |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Percentage of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline. | Week 12 (n=344; n=330; n=354) | 94.2 percentage of participants |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Percentage of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline. | Week 4 (n=343; n=330; n=352) | 79.8 percentage of participants |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Percentage of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline. | Week 12 (n=344; n=330; n=354) | 89.3 percentage of participants |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Percentage of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline. | Week 8 (n=344; n=330; n=353) | 85.6 percentage of participants |
Secondary
Percent of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline and Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline.
Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at each week indicated, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the non-missing values of the 3 serial trough sitting blood pressure measurements.
Time frame: Baseline, Week 4, Week 8 and Week 12.
Population: Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Percent of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline and Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline. | Week 4 (n=343; n=330; n=352) | 81.3 percent of participants |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Percent of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline and Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline. | Week 8 (n=344; n=330; n=353) | 88.1 percent of participants |
| Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD | Percent of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline and Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline. | Week 12 (n=344; n=330; n=354) | 91.3 percent of participants |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Percent of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline and Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline. | Week 12 (n=344; n=330; n=354) | 92.4 percent of participants |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Percent of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline and Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline. | Week 8 (n=344; n=330; n=353) | 87.3 percent of participants |
| Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD | Percent of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline and Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline. | Week 4 (n=343; n=330; n=352) | 84.8 percent of participants |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Percent of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline and Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline. | Week 12 (n=344; n=330; n=354) | 84.7 percent of participants |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Percent of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline and Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline. | Week 8 (n=344; n=330; n=353) | 81.0 percent of participants |
| Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD | Percent of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline and Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline. | Week 4 (n=343; n=330; n=352) | 74.4 percent of participants |