An Eight Week, Double-blind, Randomized, Multicenter, Parallel Group, Active-controlled Study Comparing the Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg to Ramipril 5 mg in Patients With Essential Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 1,613
- 试验地点
- 1
- 主要终点
- Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
研究概览
简要总结
This study is designed to investigate the efficacy, safety and tolerability of aliskiren 300 mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential 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 must have msDBP ≥ 90 mmHg and < 110 mmHg at the visit immediately prior to Visit 3
- •Patients must have msDBP >OR= 95 mmHg and < 110 mmHg at Visit 3
- •Patients must have an absolute difference of < or =10 mmHg in their mean sitting diastolic blood pressure (msDBP) from Visit 2 to Visit 3
排除标准
- •Severe hypertension (grade 3 WHO classification; msDBP >or= 110 mmHg and/or msSBP >or = 180 mmHg).
- •History or evidence of a secondary form of hypertension.
- •History of transient ischemic cerebral attack within 12 months of visit
- •Current angina pectoris requiring pharmacological therapy (other than those patients on a stable dose of oral or topical nitrates)
- •Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8% at Visit
- •Known or suspected contraindications to the study medications, including history of allergy to ramipril or other ACE Inhibitors.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Aliskiren 300 mg
Aliskiren 300 mg once daily
干预措施: Aliskiren (Drug)
Aliskiren 150 mg
Aliskiren 150 mg once daily
干预措施: Aliskiren (Drug)
Aliskiren 75 mg
Aliskiren 75 mg once daily
干预措施: Aliskiren (Drug)
Ramipril 5 mg
Ramipril 5 mg once daily
干预措施: Ramipril (Drug)
结局指标
主要结局
Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
时间窗: Baseline and Week 8
To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint
Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
时间窗: Baseline and Week 8
To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint
Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
时间窗: Baseline and Week 8
To evaluate the non-inferiority of aliskiren 75 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint
次要结局
- Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint(Baseline and Week 8)
- Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg(Week 8)
- Evaluation of the Percentage of Responders on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg, Define as msDBP < 90 mmHg or ≥ 10mmHg Decrease From Baseline in msDBP(Week 8)