An 8-week Multicenter, Randomized, Double-blind, Active Controlled, Parallel Group, Forced Titration Study to Evaluate the Efficacy and Safety of Aliskiren/Amlodipine/HCTZ Compared to Aliskiren/Amlodipine in US Minority Patients With Stage 2 Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 412
- 试验地点
- 5
- 主要终点
- Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
研究概览
简要总结
The purpose of the study is to compare the combination of aliskiren, amlodipine and Hydrochlorothiazide (HCTZ) versus the combination of aliskiren and amlodipine as therapy in minority Stage 2 hypertensive patients.
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 newly diagnosed or have a history of hypertension, who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
- •Men or women 18 years and older of minority background; self-identified.
- •Patients with stage 2 hypertension defined as MSSBP ≥160 mmHg and <200 mmHg at Visit 5 (randomization).
排除标准
- •Patients with MSDBP ≥110 mmHg and/or MSSBP ≥200 mmHg as measured by office cuff at any visit.
- •Patients on 4 or more antihypertensive medications.
- •Patients with uncontrolled hypertension (MSSBP >180 mmHg) taking more than 1 antihypertensive medication at Visit 1.
研究组 & 干预措施
Triple Therapy (Aliskiren/Amlodipine/HCTZ)
At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
干预措施: Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ) (Drug)
Dual Therapy (Aliskiren/Amlodipine)
At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
干预措施: Aliskiren/Amlodipine (Drug)
结局指标
主要结局
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
时间窗: Baseline and week 8
To evaluate change from baseline in MSSBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.
次要结局
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8(Baseline and week 8)
- Percentage of Patients Achieving Blood Pressure Control (Defined as MSSBP < 140 mmHg and MSDBP < 90 mmHg) During 8 Weeks(8 weeks)
- Percentage of Responders (Defined as Patients With MSSBP < 140 mmHg or a Reduction From Baseline in MSSBP of ≥20 mmHg) During 8 Weeks.(8 weeks)