NCT00772577已完成4 期
An 8-Week Prospective, Multicenter, Randomized, Double-Blind, Active Control, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
研究概览
简要总结
Study to Evaluate the Efficacy and Safety of Aliskiren Hydrochlorothiazide (HCTZ) vs Ramipril in Obese patients (BMI ≥ 30) with Stage 2 Hypertension
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
- •Male or female outpatients, 18 years of age and older.
- •Patients with Stage 2 hypertension. Patients must have a MSSBP ≥ 160 mmHg and < 200 mmHg at Study Visit 5 (randomization).
- •Patients must have a BMI ≥ 30 kg/m2 but ≤ 45 kg/m2.
排除标准
- •Office blood pressure measured by cuff (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 200 mmHg) at any visit.
- •Use of other investigational drugs within 30 days of enrollment, or 5 half-lives, which ever is longer.
- •Use of aliskiren and/or a fixed dose combination of aliskiren HCTZ or participation in a clinical trial that had aliskiren and/or aliskiren HCTZ as treatment within 30 days of Visit
- •History of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (ACE inhibitors or renin inhibitors) as the study drugs.
- •History or evidence of a secondary form of hypertension.
- •Refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
- •Patients on 4 or more antihypertensive medications.
- •Long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
1
Experimental
Aliskiren Hydrochlorothiazide(HCTZ)
干预措施: Aliskiren Hydrochlorothiazide (Drug)
2
Active Comparator
Ramipril
干预措施: Ramipril (Drug)
结局指标
主要结局
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
时间窗: Baseline to week 8
To assess the change in mean sitting systolic blood pressure (MSSBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).
次要结局
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)(Baseline to week 8)
- Percentage of Patients Achieving Blood Pressure Control During 8 Weeks(8 weeks)
- Percentage of Responders (MSSBP < 140 mmHg or ≥ 20 mmHg Decrease From Baseline in MSSBP)(8 weeks)
- Change From Baseline in Mean Sitting Pulse Pressure (MSPP)(Baseline to week 8)
研究者
研究点 (1)
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