Essential Hypertension
Conditions
Keywords
Drug therapy
Brief summary
The purpose of this study is to evaluate the antihypertensive effect of azilsartan medoxomil compared with valsartan in Chinese participants with essential hypertension.
Detailed description
The drug being tested in this study is called TAK-491 (azilsartan medoxomil). Azilsartan medoxomil is being tested to treat Chinese people who have essential hypertension. This study will look at change in blood pressure after 8 weeks of treatment in people who take azilsartan medoxomil compared to people who take valsartan. The study enrolled 612 patients. Prior to the start of study treatment, participants who have not received antihypertensive treatment within 28 days participated in a 2-week -run in period. Upon completion of the run-in period, participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * azilsartan medoxomil 40 mg * azilsartan medoxomil 80 mg * Valsartan 160 mg All participants were asked to take study medication at the same time each day throughout the study. This multi-centre trial was conducted in China. The overall time to participate in this study is up to 14 weeks. Participants made 9 visits to the clinic and contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
Interventions
Azilsartan medoxomil tablets
DRUGValsartan
Valsartan 80 mg capsules
Azilsartan medoxomil placebo-matching tablets
Valsartan placebo-matching capsules
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. Is treated with antihypertensive therapy and has a post-washout mean sitting clinic systolic blood pressure (SBP) ≥150 and ≤180 mm Hg on Day 1; or the participant has not received antihypertensive treatment within 28 days prior to Screening and has a mean sitting clinic SBP ≥150 and ≤180 mm Hg at the Screening Visit and on Day 1. 2. Is a man or woman aged 18 years or older. 3. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 4. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 5. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent through 30 days after last study drug dose. 6. Has clinical laboratory test results (clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the investigator does not consider the results to be clinically significant. 7. Is willing to discontinue current antihypertensive medications on Day -21 or on Day -28 if the participant is on amlodipine or chlorthalidone.
Exclusion criteria
1. Has a mean, sitting clinic diastolic blood pressure (DBP) greater than 110 mm Hg at Day 1 (after placebo run in). 2. Is non-compliant (less than 70% or greater than 130%) with study medication during placebo run-in period. 3. Has secondary hypertension of any etiology (eg, renovascular disease documented as the cause of hypertension, pheochromocytoma, Cushing's syndrome). 4. Has a history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack. 5. Has clinically significant cardiac conduction defects (eg, third-degree atrioventricular block, sick sinus syndrome). 6. Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease and hypertrophic obstructive cardiomyopathy (HOCM). 7. Has severe renal dysfunction or disease (based on estimated glomerular filtration rate \[GFR\] \<30 mL/min/1.73 m\^2) at Screening. 8. Has known or suspected unilateral or bilateral renal artery stenosis. 9. Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. (This criterion does not apply to those participants with basal cell or Stage 1 squamous cell carcinoma of the skin). 10. Has type 1 or poorly controlled type 2 diabetes mellitus (hemoglobin A1c \[HbA1c\] \>8.5%) at Screening. 11. Has hyperkalemia (defined as serum potassium above the normal reference range of the central laboratory) at Screening. 12. Has an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level of greater than 2.5 times the upper limit of normal (ULN), active liver disease, or jaundice at Screening. 13. Has any other known serious disease or condition at Screening (or Randomization) that would compromise participant safety, might affect life expectancy, or make it difficult to successfully manage and follow the participant according to the protocol. 14. Has a history of hypersensitivity or allergies to TAK-491 (azilsartan medoxomil), any of its excipients or other angiotension II (AII) receptor blockers (ARBs). 15. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study; or intending to donate ova during such time period. 16. Is currently participating in another investigational study or is receiving or has received any investigational compound within 30 days prior to the first dose of study medication. Note: This criterion does not apply to participants who participated in observational studies that lacked an intervention or invasive procedure. 17. Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress. 18. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within the past 2 years. 19. Is taking or expected to take an excluded medication. 20. Works a night (third) shift (defined as 11 PM \[2300\] to 7 AM \[0700\]). (Only for participants with ambulatory blood pressure monitoring \[ABPM\].) 21. Has an upper arm circumference \<24 cm or \>42 cm. (Only for participants with ABPM.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure (SBP) | Baseline and Week 8 | The change in trough clinic sitting SBP measured at Week 8 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting SBP measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved a Clinic SBP Response at Week 8 | Week 8 | Clinic SBP response was defined as clinic SBP \<140 mm Hg and/or reduction of ≥20 mm Hg from Baseline. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. |
| Percentage of Participants Who Achieved a Clinic DBP Response at Week 8 | Week 8 | Clinic DBP response was defined as clinic DBP \<90 mm Hg and/or reduction of ≥10 mm Hg from Baseline. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. |
| Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure (DBP) | Baseline and Week 8 | The change in trough clinic sitting DBP measured at Week 8 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting DBP measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. |
| Percentage of Participants Who Achieved Target Clinic SBP <140 mm Hg, Clinic DBP <90 mm Hg or Both at Week 8 | Week 8 | Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. |
| Percentage of Participants Who Achieved Target Clinic SBP <130 mm Hg, Target Clinic DBP <80 mm Hg or Both at Week 8 | Week 8 | Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. |
| Percentage of Participants Who Achieved Both Clinic SBP and DBP Response at Week 8 | Week 8 | Clinic SBP response was defined as clinic SBP \<140 mm Hg and/or reduction of ≥20 mm Hg from Baseline and clinic DBP response was defined as clinic DBP \<90 mm Hg and/or reduction of ≥10 mm Hg from Baseline. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. |
Countries
China
Participant flow
Recruitment details
Participants took part in the study at 30 investigative sites in China from 27 August 2015 to 13 October 2017.
Pre-assignment details
Participants with a diagnosis of hypertension were randomized at a ratio of 1:1:1 into 1 of 3 treatment groups, once a day azilsartan medoxomil 40 mg, azilsartan medoxomil 80 mg or valsartan 160 mg.
Participants by arm
| Arm | Count |
|---|---|
| Azilsartan Medoxomil 40 mg Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: azilsartan medoxomil 40 mg tablets, orally, once daily, azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for up to 8 weeks. | 199 |
| Azilsartan Medoxomil 80 mg Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: azilsartan medoxomil 80 mg tablets, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for up to 8 weeks. | 209 |
| Valsartan 160 mg Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: valsartan two 80 mg capsules, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, for up to 8 weeks. | 204 |
| Total | 612 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 3 | 3 |
| Overall Study | Lost to Follow-up | 0 | 1 | 2 |
| Overall Study | Major Protocol Deviation | 1 | 4 | 3 |
| Overall Study | Pretreatment Event/Adverse Event | 3 | 6 | 3 |
| Overall Study | Reason not Specified | 0 | 1 | 0 |
| Overall Study | Voluntary Withdrawal | 6 | 5 | 10 |
Baseline characteristics
| Characteristic | Valsartan 160 mg | Azilsartan Medoxomil 80 mg | Azilsartan Medoxomil 40 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 9.48 | 57.0 years STANDARD_DEVIATION 9.88 | 57.4 years STANDARD_DEVIATION 9.52 | 57.1 years STANDARD_DEVIATION 9.62 |
| Baseline glycosylated haemoglobin (HbA1c) | 5.75 Percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.716 | 5.77 Percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.793 | 5.67 Percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.569 | 5.73 Percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.701 |
| Body Mass Index (BMI) | 26.52 kg/m^2 STANDARD_DEVIATION 3.444 | 26.47 kg/m^2 STANDARD_DEVIATION 3.436 | 26.43 kg/m^2 STANDARD_DEVIATION 3.784 | 26.48 kg/m^2 STANDARD_DEVIATION 3.55 |
| Estimated Glomerular Filtration Rate (eGFR) | 108.00 mL/min/1.73m^2 STANDARD_DEVIATION 29.206 | 110.45 mL/min/1.73m^2 STANDARD_DEVIATION 28.771 | 109.50 mL/min/1.73m^2 STANDARD_DEVIATION 26.309 | 109.32 mL/min/1.73m^2 STANDARD_DEVIATION 28.116 |
| Female Reproductive Status Female of Childbearing Potential | 16 Participants | 18 Participants | 12 Participants | 46 Participants |
| Female Reproductive Status N/A (Participant is Male) | 130 Participants | 115 Participants | 107 Participants | 352 Participants |
| Female Reproductive Status Postmenopausal | 51 Participants | 71 Participants | 68 Participants | 190 Participants |
| Female Reproductive Status Surgically Sterile | 7 Participants | 5 Participants | 12 Participants | 24 Participants |
| Height | 165.3 cm STANDARD_DEVIATION 7.73 | 164.2 cm STANDARD_DEVIATION 8.81 | 164.3 cm STANDARD_DEVIATION 8.92 | 164.6 cm STANDARD_DEVIATION 8.5 |
| Race/Ethnicity, Customized Asian | 204 Participants | 209 Participants | 199 Participants | 612 Participants |
| Region of Enrollment China | 204 Participants | 209 Participants | 199 Participants | 612 Participants |
| Sex: Female, Male Female | 74 Participants | 94 Participants | 92 Participants | 260 Participants |
| Sex: Female, Male Male | 130 Participants | 115 Participants | 107 Participants | 352 Participants |
| Smoking Classification Participant has never smoked | 136 Participants | 147 Participants | 151 Participants | 434 Participants |
| Smoking Classification Participant is a current smoker | 55 Participants | 51 Participants | 39 Participants | 145 Participants |
| Smoking Classification Participant is an ex-smoker | 13 Participants | 11 Participants | 9 Participants | 33 Participants |
| Weight | 72.79 kg STANDARD_DEVIATION 12.903 | 71.60 kg STANDARD_DEVIATION 11.903 | 71.75 kg STANDARD_DEVIATION 14.046 | 72.05 kg STANDARD_DEVIATION 12.952 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 199 | 0 / 209 | 0 / 204 |
| other Total, other adverse events | 34 / 199 | 37 / 209 | 35 / 204 |
| serious Total, serious adverse events | 2 / 199 | 7 / 209 | 6 / 204 |
Outcome results
Primary
Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure (SBP)
The change in trough clinic sitting SBP measured at Week 8 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting SBP measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose.
Time frame: Baseline and Week 8
Population: Full Analysis Set (FAS) included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using last observation carried forward (LOCF). Number analyzed at a visit is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Azilsartan Medoxomil 40 mg | Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure (SBP) | Baseline SBP | 157.873 mm Hg | Standard Error 0.5123 |
| Azilsartan Medoxomil 40 mg | Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure (SBP) | Change at Week 8 | -22.483 mm Hg | Standard Error 1.0258 |
| Azilsartan Medoxomil 80 mg | Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure (SBP) | Baseline SBP | 158.236 mm Hg | Standard Error 0.501 |
| Azilsartan Medoxomil 80 mg | Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure (SBP) | Change at Week 8 | -24.236 mm Hg | Standard Error 1.0027 |
| Valsartan 160 mg | Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure (SBP) | Baseline SBP | 158.594 mm Hg | Standard Error 0.5123 |
| Valsartan 160 mg | Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure (SBP) | Change at Week 8 | -20.551 mm Hg | Standard Error 1.0258 |
p-value: 0.18495% CI: [-4.782, 0.918]ANCOVA
p-value: 0.0195% CI: [-6.502, -0.868]ANCOVA
Secondary
Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure (DBP)
The change in trough clinic sitting DBP measured at Week 8 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting DBP measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose.
Time frame: Baseline and Week 8
Population: FAS included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using LOCF. Number analyzed at a visit is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Azilsartan Medoxomil 40 mg | Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure (DBP) | Baseline DBP | 91.790 mm Hg | Standard Error 0.7306 |
| Azilsartan Medoxomil 40 mg | Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure (DBP) | Change at Week 8 | -10.101 mm Hg | Standard Error 0.6684 |
| Azilsartan Medoxomil 80 mg | Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure (DBP) | Baseline DBP | 91.510 mm Hg | Standard Error 0.7145 |
| Azilsartan Medoxomil 80 mg | Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure (DBP) | Change at Week 8 | -11.463 mm Hg | Standard Error 0.6538 |
| Valsartan 160 mg | Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure (DBP) | Baseline DBP | 92.298 mm Hg | Standard Error 0.7306 |
| Valsartan 160 mg | Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure (DBP) | Change at Week 8 | -8.641 mm Hg | Standard Error 0.6686 |
p-value: 0.12395% CI: [-3.316, 0.397]ANCOVA
p-value: 0.00395% CI: [-4.659, -0.985]ANCOVA
Secondary
Percentage of Participants Who Achieved a Clinic DBP Response at Week 8
Clinic DBP response was defined as clinic DBP \<90 mm Hg and/or reduction of ≥10 mm Hg from Baseline. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose.
Time frame: Week 8
Population: FAS included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using LOCF.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azilsartan Medoxomil 40 mg | Percentage of Participants Who Achieved a Clinic DBP Response at Week 8 | 81.2 percentage of participants |
| Azilsartan Medoxomil 80 mg | Percentage of Participants Who Achieved a Clinic DBP Response at Week 8 | 81.6 percentage of participants |
| Valsartan 160 mg | Percentage of Participants Who Achieved a Clinic DBP Response at Week 8 | 79.7 percentage of participants |
p-value: 0.90495% CI: [0.607, 1.759]Regression, Logistic
p-value: 0.7995% CI: [0.633, 1.823]Regression, Logistic
Secondary
Percentage of Participants Who Achieved a Clinic SBP Response at Week 8
Clinic SBP response was defined as clinic SBP \<140 mm Hg and/or reduction of ≥20 mm Hg from Baseline. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose.
Time frame: Week 8
Population: FAS included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using LOCF.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azilsartan Medoxomil 40 mg | Percentage of Participants Who Achieved a Clinic SBP Response at Week 8 | 67.0 percentage of participants |
| Azilsartan Medoxomil 80 mg | Percentage of Participants Who Achieved a Clinic SBP Response at Week 8 | 68.9 percentage of participants |
| Valsartan 160 mg | Percentage of Participants Who Achieved a Clinic SBP Response at Week 8 | 69.0 percentage of participants |
p-value: 0.54895% CI: [0.571, 1.347]Regression, Logistic
p-value: 0.92195% CI: [0.638, 1.501]Regression, Logistic
Secondary
Percentage of Participants Who Achieved Both Clinic SBP and DBP Response at Week 8
Clinic SBP response was defined as clinic SBP \<140 mm Hg and/or reduction of ≥20 mm Hg from Baseline and clinic DBP response was defined as clinic DBP \<90 mm Hg and/or reduction of ≥10 mm Hg from Baseline. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose.
Time frame: Week 8
Population: FAS included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using LOCF.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azilsartan Medoxomil 40 mg | Percentage of Participants Who Achieved Both Clinic SBP and DBP Response at Week 8 | 62.9 percentage of participants |
| Azilsartan Medoxomil 80 mg | Percentage of Participants Who Achieved Both Clinic SBP and DBP Response at Week 8 | 67.0 percentage of participants |
| Valsartan 160 mg | Percentage of Participants Who Achieved Both Clinic SBP and DBP Response at Week 8 | 64.5 percentage of participants |
p-value: 0.62495% CI: [0.594, 1.367]Regression, Logistic
p-value: 0.64795% CI: [0.726, 1.674]Regression, Logistic
Secondary
Percentage of Participants Who Achieved Target Clinic SBP <130 mm Hg, Target Clinic DBP <80 mm Hg or Both at Week 8
Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose.
Time frame: Week 8
Population: FAS included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azilsartan Medoxomil 40 mg | Percentage of Participants Who Achieved Target Clinic SBP <130 mm Hg, Target Clinic DBP <80 mm Hg or Both at Week 8 | Clinic DBP <80 mm Hg | 45.2 percentage of participants |
| Azilsartan Medoxomil 40 mg | Percentage of Participants Who Achieved Target Clinic SBP <130 mm Hg, Target Clinic DBP <80 mm Hg or Both at Week 8 | Clinic SBP <130 mm Hg | 37.6 percentage of participants |
| Azilsartan Medoxomil 40 mg | Percentage of Participants Who Achieved Target Clinic SBP <130 mm Hg, Target Clinic DBP <80 mm Hg or Both at Week 8 | Clinic SBP <130 mm Hg and DBP <80 mm Hg | 28.9 percentage of participants |
| Azilsartan Medoxomil 80 mg | Percentage of Participants Who Achieved Target Clinic SBP <130 mm Hg, Target Clinic DBP <80 mm Hg or Both at Week 8 | Clinic DBP <80 mm Hg | 51.9 percentage of participants |
| Azilsartan Medoxomil 80 mg | Percentage of Participants Who Achieved Target Clinic SBP <130 mm Hg, Target Clinic DBP <80 mm Hg or Both at Week 8 | Clinic SBP <130 mm Hg | 42.7 percentage of participants |
| Azilsartan Medoxomil 80 mg | Percentage of Participants Who Achieved Target Clinic SBP <130 mm Hg, Target Clinic DBP <80 mm Hg or Both at Week 8 | Clinic SBP <130 mm Hg and DBP <80 mm Hg | 33.0 percentage of participants |
| Valsartan 160 mg | Percentage of Participants Who Achieved Target Clinic SBP <130 mm Hg, Target Clinic DBP <80 mm Hg or Both at Week 8 | Clinic SBP <130 mm Hg | 28.4 percentage of participants |
| Valsartan 160 mg | Percentage of Participants Who Achieved Target Clinic SBP <130 mm Hg, Target Clinic DBP <80 mm Hg or Both at Week 8 | Clinic SBP <130 mm Hg and DBP <80 mm Hg | 21.8 percentage of participants |
| Valsartan 160 mg | Percentage of Participants Who Achieved Target Clinic SBP <130 mm Hg, Target Clinic DBP <80 mm Hg or Both at Week 8 | Clinic DBP <80 mm Hg | 37.1 percentage of participants |
p-value: 0.07795% CI: [0.958, 2.307]Regression, Logistic
p-value: 0.00395% CI: [1.241, 2.951]Regression, Logistic
p-value: 0.13795% CI: [0.893, 2.28]Regression, Logistic
p-value: 0.00395% CI: [1.263, 3.22]Regression, Logistic
p-value: 0.1495% CI: [0.891, 2.276]Regression, Logistic
p-value: 0.01595% CI: [1.118, 2.797]Regression, Logistic
Secondary
Percentage of Participants Who Achieved Target Clinic SBP <140 mm Hg, Clinic DBP <90 mm Hg or Both at Week 8
Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose.
Time frame: Week 8
Population: FAS included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azilsartan Medoxomil 40 mg | Percentage of Participants Who Achieved Target Clinic SBP <140 mm Hg, Clinic DBP <90 mm Hg or Both at Week 8 | Clinic DBP <90 mm Hg | 77.2 percentage of participants |
| Azilsartan Medoxomil 40 mg | Percentage of Participants Who Achieved Target Clinic SBP <140 mm Hg, Clinic DBP <90 mm Hg or Both at Week 8 | Clinic SBP <140 mm Hg | 60.9 percentage of participants |
| Azilsartan Medoxomil 40 mg | Percentage of Participants Who Achieved Target Clinic SBP <140 mm Hg, Clinic DBP <90 mm Hg or Both at Week 8 | Clinic SBP <140 mm Hg and DBP <90 mm Hg | 58.4 percentage of participants |
| Azilsartan Medoxomil 80 mg | Percentage of Participants Who Achieved Target Clinic SBP <140 mm Hg, Clinic DBP <90 mm Hg or Both at Week 8 | Clinic DBP <90 mm Hg | 76.7 percentage of participants |
| Azilsartan Medoxomil 80 mg | Percentage of Participants Who Achieved Target Clinic SBP <140 mm Hg, Clinic DBP <90 mm Hg or Both at Week 8 | Clinic SBP <140 mm Hg and DBP <90 mm Hg | 60.2 percentage of participants |
| Azilsartan Medoxomil 80 mg | Percentage of Participants Who Achieved Target Clinic SBP <140 mm Hg, Clinic DBP <90 mm Hg or Both at Week 8 | Clinic SBP <140 mm Hg | 62.6 percentage of participants |
| Valsartan 160 mg | Percentage of Participants Who Achieved Target Clinic SBP <140 mm Hg, Clinic DBP <90 mm Hg or Both at Week 8 | Clinic SBP <140 mm Hg | 62.9 percentage of participants |
| Valsartan 160 mg | Percentage of Participants Who Achieved Target Clinic SBP <140 mm Hg, Clinic DBP <90 mm Hg or Both at Week 8 | Clinic SBP <140 mm Hg and DBP <90 mm Hg | 55.8 percentage of participants |
| Valsartan 160 mg | Percentage of Participants Who Achieved Target Clinic SBP <140 mm Hg, Clinic DBP <90 mm Hg or Both at Week 8 | Clinic DBP <90 mm Hg | 74.6 percentage of participants |
p-value: 0.40495% CI: [0.537, 1.284]Regression, Logistic
p-value: 0.76895% CI: [0.606, 1.447]Regression, Logistic
p-value: 0.85295% CI: [0.62, 1.784]Regression, Logistic
p-value: 0.86895% CI: [0.62, 1.763]Regression, Logistic
p-value: 0.84795% CI: [0.684, 1.59]Regression, Logistic
p-value: 0.4695% CI: [0.769, 1.785]Regression, Logistic