CTRI/2017/12/010961
Completed
Phase 3
A Double Blind, Randomized, Multicentric, Active Controlled, Parallel group,Comparative Phase III study to evaluate the Efficacy and Safety of fixed dose combination of Azilsartan medoxomil and Chlorthalidone versus fixed dose combination of Olmesartan medoxomil and Hydrochlorothiazide in patients with moderate to severe hypertension
SYNOKEM Pharmaceuticals Limited7 sites in 1 country306 target enrollmentStarted: December 26, 2017Last updated:
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- SYNOKEM Pharmaceuticals Limited
- Enrollment
- 306
- Locations
- 7
- Primary Endpoint
- Change from Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure
Overview
Brief Summary
High blood pressure is a long term medical condition and is the most common modifiable risk factor for cardiovascular disease and death. Single drug therapy remains the preferred way to begin treatment of hypertension, although in some patients this is unable to bring blood pressure (BP) to goal levels.
This study drug is an anti-hypertensive tablet which is a fixed dose combination (FDC) of Azilsartan medoxomil, an inhibitor of the reninangiotensin-
aldosterone system and Chlorthalidone, a thiazide-type diuretic. Thus current study aims to evaluate the efficacy and safety of FDC of Azilsartan medoxomil and chlorthalidone in Indian population patient having moderate to severe Hypertension. Study composed of total 6 visits with approximately 84 days (12 weeks). Total 306 patients will be randomized in 1:1 ratio for test drug and control drug. Efficacy will be determined on the measurement of Systolic blood pressure and diastolic blood pressure.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Men and women between 18-65 years of age (Both are inclusive).
- •Newly diagnosed patients or De novo patients are eligible for study.
- •Patient willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures
- •Patient having moderate to severe systolic hypertension (defined as sitting trough clinic systolic blood pressure is between 160 mmHg and 190 mmHg inclusive at screening visit)
- •Patients with sitting diastolic hypertension (DBP) <119 mmHg at screening visit
- •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.
- •Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
Exclusion Criteria
- •Clinically significant renal (estimated glomerular filtration rate: <30 mL/min per 1.73 m2) metabolic, hepatic, or psychiatric disorders.
- •Hypersensitive to angiotensin II receptor blockers or diuretics or any ingredient of the formulation.
- •Recent history (within the last 6 months) of myocardial infarction, Patients with NYHA class III and IV heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack
- •Clinically relevant or unstable cardiovascular diseases
- •Type 1 or poorly controlled type 2 diabetes mellitus (HbA1c: ≥ 8%).
- •Pregnant, nursing women or women with childbearing potential not using medically approved means of contraception
- •Patients taking any antihypertensive or concomitant medications known to affect BP.
- •Those with any medical condition judged by investigators to possibly jeopardize the evaluation of efficacy and safety of therapy were excluded from the study.
- •Secondary hypertension of any etiology.
- •Subject who have used any investigational drug or device within 30 days or 5 half-lives of randomization preceding informed consent or scheduled to participate in another clinical study involving an investigational product or investigational drug during the course of this study.
Outcomes
Primary Outcomes
Change from Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure
Time Frame: Day 1, Day 28, Day 42 and Day 84
Secondary Outcomes
- Change from Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure(Day 1, Day 28, Day 42 and Day 84)
- Change from Baseline in the 24-hour Mean Systolic and Diastolic Blood Pressure measured by Ambulatory Blood Pressure Monitoring(Day 1 and Day 84)
- Percentage of responders at the end of 12 weeks of the treatment period(Day 28, Day 42 and Day 84)
Investigators
Study Sites (7)
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