Comparative Evaluation of Safety and Efficacy of Hydrochlorothiazide CR with Hydrochlorothiazide and Chlorthalidone in patients with Stage I Essential Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 213
- 试验地点
- 16
- 主要终点
- 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 12
研究概览
简要总结
This is a randomized, comparative, double blind, double dummy, parallel group, multicentric study comparing efficacy and safety of Hydrochlorothiazide CR with Conventional Hydrochlorothiazide and Chlorthalidone in Patients with Stage 1 Essential Hypertension.The primary objective is to demonstrate that Hydrochlorothiazide CR 12.5 mg is as effective as Chlorthalidone 6.25 mg and is superior to Conventional Hydrochlorothiazide 12.5 mg with respect to change in 24-hr mean systolic (SBP) and diastolic (DBP) ambulatory BP from baseline to Week 4 and Week 12.The secondary objective is to compare the change in mean office SBP and DBP at each visit from baseline, to compare the change in ambulatory daytime and nighttime mean SBP and mean DBP from baseline to Week 4 and Week 12 and to assess the safety and tolerability of the test product as compared to the reference product
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •i)patients with Systolic Blood Pressure-140-159mmHg and Diastolic Blood Pressure-90-99mmHg.
排除标准
- •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.
结局指标
主要结局
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 12
时间窗: 24 hr ABPM will be meausred at baseline, Week 4, and Week 12.
次要结局
- i)To compare change in mean office systolic and diastolic blood pressure at each visit from baseline(ii)To compare change in ambulatory daytime and nighttime mean systolic and diastolic blood pressure from baseline to week 4 and week 12)