Evaluation of safety and efficacy of Controlled release Hydrochlorothiazide in stage I Essential Hypertensio
Phase 3
Completed
- Conditions
- Health Condition 1: I10- Essential (primary) hypertension
- Registration Number
- CTRI/2013/07/003793
- Lead Sponsor
- Ipca Laboratories Ltd Mumbai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 54
Inclusion Criteria
i)patients with Systolic Blood Pressure-140-159mmHg and Diastolic Blood Pressure-90-99mmHg
Exclusion Criteria
i)patients with secondary hypertension
ii) Patients with significant cardiovascular disease
iii)Patients with abnormal renal, liver function
iv)Patients currently uncontrolled on thiazide type diuretics
v)patients who have used another investigational agent/device within last 30 days prior to enrollment
vi) Patients taking concomitant medications known to alter the blood pressure or to affect the action of study drug
vii) Patients with known history of hypersensitivity to study drugs or other drugs of same chemical class
viii) Pregnant or lactating women or women of child-bearing potential not practicing contraception
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate comparative efficacy of Hydrochlorothiazide(controlled release)with chlorthalidone 6.25mg and also its superiority to hydrochlorothiazide 12.5mg with respect to change in 24 hr mean systolic and diastolic ambulatory blood pressure from baseline to week 4 and week 12Timepoint: 24 hr ABPM will be meausred at baseline, Week 4, and Week 12.
- Secondary Outcome Measures
Name Time Method i)To compare change in mean office systolic and diastolic blood pressure at each visit from baseline <br/ ><br>ii)To compare change in ambulatory daytime and nighttime mean systolic and diastolic blood pressure from baseline to week 4 and week 12 <br/ ><br>iii)To assess the safety and tolerabilty of test drugs compared to reference productTimepoint: i)Office systolic and diastolic blood pressure will be measured at baseline, Day 7, Day 14, Day 28, Day 42, Day 56,Day 70,Day 84 <br/ ><br>ii)mean day-time and night-time ambulatory measurements at baseline, Week 4 and Week 12. <br/ ><br>iii) Safety and tolerability of study medications throughout the study