None listed
Conditions
Interventions
Group 1 Type of group
Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.
Group name:Group 2 Type of group
Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.
Sponsors
TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • The subject is treated with antihypertensive therapy and has a mean clinical SBP in a sitting position after pharmacological rest> 160 and 160 and <190 mm Hg on the Selection Visit and on Day -1. • The subject is a man or woman 18 years of age or older. • A female participant of childbearing age who is sexually active agrees to routinely use appropriate contraceptive methods from the Selection until 30 days after the last administered dose of the study drug. • The subject has clinical laboratory test results (clinical biochemistry, hematology and complete urine analysis) within the reference range corresponding to the laboratory test or the researcher does not consider the results to be clinically significant. • The subject is willing to discontinue their current antihypertensive drugs on Day -21 or Day -28 if the subject is receiving amlodipine or chlorthalidone.
Exclusion criteria
Exclusion criteria: • The subject has a mean clinical PAD in a sitting position> 119 mm Hg on Day -1. • The subject has a baseline MAP determination for 24 hours of insufficient quality. • The subject works a (third) night tumo (defined as 11 PM [2300] to 7 AM [0700]). • The subject has a circumference of the upper arm 42 cm. • Subject fails ( 130%) with the study drug during the placebo stabilization period. • The subject has a secondary hypertension of any etiology (for example, renovascular disease, pheochromocytoma, Cushing´s syndrome). • The subject has a recent history (within the last 6 months) of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, stroke, or transient ischemic attack. • The subject has clinically significant cardiac conduction defects (ie, third degree atrioventricular block, sick sinus syndrome, atrial fibrillation or atrial flutter). • The subject has a hemodynamically significant left ventricular outflow tract obstruction due to aortic valve disease. • The subject has severe renal dysfunction or nephropathy (based on the estimated GFR 8.0%) in the Selection. • The subject has hypokalemia or hyperkalemia (defined as serum potassium outside the normal reference range of the central laboratory). • The subject has a level of alanine aminotransferase or aspartate aminotransferase greater than 2.5 times the normal upper index, active liver disease or jaundice. • The subject has known hypersensitivity to angiotensin II receptor blockers or thiazide-type diuretics or other sulfonamide-derived compounds. • In the case of women, the subject is pregnant or breastfeeding or intends to become pregnant before or during their participation in the study, or within 30 days after the last administered dose of the drug of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The change in sitting trough clinic systolic blood pressure measured at each week indicated including final visit relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements. Measure:Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure Timepoints:Baseline, Week 6 and Week 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The change in sitting trough clinic diastolic blood pressure measured at each week indicated including final visit relative to baseline. Diastolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements. Measure:Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure Timepoints:Baseline, Week 6 and Week 10 ; Outcome name:The change in trough systolic blood pressure measured at each week indicated including final visit 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 in Mean Trough Systolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring. Timepoints:Baseline, Week 6 and Week 10 ; Outcome name:The change in trough diastolic blood pressure measured at each week indicated including final visit 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 in Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring Timepoints:Baseline, Week 6 and Week 10 ; Outcome name:The change in 24-hour mean systolic blood pressure measured at each visit indicated including 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. Measure:Change From Baseline in 24-hour Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring Timepoints:Baseline, Week 6 and Week 10 | — |
Countries
Peru, Russian Federation, United States
Contacts
Public ContactEduardo Gotuzzo
GOTUZZO ASOCIADOS S.A.C.
Outcome results
None listed