A 16-week, Prospective, Open Label, Multicenter Study to Evaluate the Effectiveness and Safety of Rasilez® (Aliskiren) Monotherapy or in Addition With Hydrochlorothiazide 12.5 mg or 25 mg in Patients With Hypertension Stage I and II
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- The proportion of patients in whom BP control was achieved at the study end point
研究概览
简要总结
This is an open-label, not controlled, sequential, dose escalation study of 16 weeks' duration. The study is composed of two periods: a 0-2 week optional wash-out period depending on previous antihypertensive treatment(s), followed by a 16-week open-label active treatment period. Patients will be evaluated every 4 weeks during period 2. Treatment will start with Aliskiren 150 mg with dose titration to Aliskiren 300 mg, and addition of HCTZ 12,5 mg and 25 if control of BP is not achieved (< 140/90 mmHg or 130/ 80 mmHg in diabetics patients). All patients who have reached their BP target will be considered as having met the primary endpoint and this visit will be considered as the final visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients, with essential hypertension, stage I-II, naïve or not controlled with monotherapy.
排除标准
- •BP> 180/110 mmHg
- •Pregnant or nursing women
- •Hypertensive encephalopathy or cerebrovascular accident, transient ischemic - cerebral attack, myocardial infarction, unstable angina, coronary bypass surgery, percutaneous coronary intervention within 6 month
- •K <3.5 mEq/L or ≥ 5 mEq/L
- •Renal impairment
- •Hypersensitivity to HCTZ or Aliskiren or angioedema due to ACE-I or ARB
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Aliskiren and Aliskiren_HCTZ
aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg 25 mg
干预措施: Aliskiren and HCTZ (Drug)
结局指标
主要结局
The proportion of patients in whom BP control was achieved at the study end point
时间窗: 16 weeks
次要结局
- Change in msSPA and msDBP from baseline to different time points(4,8,12 and 16 weeks)
- Safety of Aliskiren therapy at different time points(4,8,12 and 16 weeks)
- The proportion of patients in whom BP control was reached before the addition of HCTZ (ie, at the pre-HCTZ end point(8 weeks)
- Percentage of patients achieving overall BP, DBP, an SBP control rate at week 4, 8, 12 and 16.(16 weeks)