None listed
Conditions
Interventions
Group 1 Type of group
Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks
Group name:Group 11 Type of group
Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks
Sponsors
TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Is treated with antihypertensive therapy and has a post-washout mean sitting clinic systolic blood pressure greater than or equal to 160 and less than or equal to 190 mm Hg on the day prior to randomization, or the participant has not received antihypertensive treatment within 28 days prior to Screening and has a mean sitting clinic systolic blood pressure greater than or equal to 160 and less than or equal to 190 mm Hg at the Screening Visit and on the day prior to randomization. • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. • 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. • Is willing to discontinue current antihypertensive medications on Day -21 or on Day -28 if on amlodipine or chlorthalidone.
Exclusion criteria
Exclusion criteria: • Has a mean sitting clinic diastolic blood pressure greater than 119 mm Hg on the day prior to randomization. • Has a baseline 24-hour ambulatory blood pressure measurement reading of insufficient quality. • Has works a night (third) shift (defined as 11 PM [2300] to 7 AM [0700]). • Has an upper arm circumference less than 24 cm or greater than 42 cm. • Has is noncompliant with study medication during the placebo run-in period. • Has secondary hypertension of any etiology. • Has recent history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack. • Has clinically significant cardiac conduction defects. • Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease. • Has severe renal dysfunction or disease. • Has known or suspected unilateral or bilateral renal artery stenosis. • Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. • Has poorly controlled type 1 or type 2 diabetes mellitus at Screening. • Has hypokalemia or hyperkalemia. • Has an alanine aminotransferase or aspartate aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice. • 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 Has according to the protocol. • Has known hypersensitivity to angiotensin II receptor blockers, thiazide-type diuretics or other sulfonamide-derived compounds. • Has been randomized in a previous azilsartan medoxomil study. • Is currently participating in another investigational study or is receiving or has received any investigational compound within 30 days prior to Screening. • Has a history of drug abuse or a history of alcohol abuse within the past 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing. Measure:Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pooled Analysis) Timepoints:Baseline and Week 8. ; Outcome name:The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing. Measure:Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pairwise Analysis) Timepoints:Baseline and Week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 serial trough sitting systolic blood pressure measurements. Measure:Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure Timepoints:Baseline and Week 8 ; Outcome name:The change in trough systolic blood pressure in black subjects measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing. Measure:Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pooled Analysis) Timepoints:Baseline and Week 8 ; Outcome name:The change in trough systolic blood pressure in black participants as measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing. Measure:Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pairwise Analysis) Timepoints:Baseline and Week 8 ; Outcome name:The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the average of the 3 serial trough clinic sitting diastolic blood pressure measurements. Measure:Change From Baseline to Week 8 in Trough, Sitting, Clinic Diastolic Blood Pressure Timepoints:Baseline and Week 8 ; Outcome name:The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring meas | — |
Countries
Chile, Mexico, Peru, Russian Federation, United States
Contacts
Public ContactEduardo Gotuzzo
GOTUZZO ASOCIADOS S.A.C.
Outcome results
None listed