NCT00778921已完成3 期
A Randomized, Eight Week Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (150/10 mg and 300/10 mg) in Comparison With Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Responsive to Amlodipine 10 mg Monotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 847
- 试验地点
- 1
- 主要终点
- Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study
研究概览
简要总结
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone.
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
- •Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 95 mmHg and < 110 mmHg at Visits 1 and 2
- •Patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 2
- •All patients must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 5 (randomization)
排除标准
- •Severe hypertension
- •Pregnant or nursing (lactating) women
- •Pre-menopausal women not taking accepted form of birth control
- •Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
- •History of cardiovascular conditions
- •Uncontrolled Type 1 or Type 2 diabetes mellitus
- •Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Amlodipine 10 mg
Experimental
Amlodipine 10 mg
干预措施: Amlodipine 10 mg (Drug)
Aliskiren/Amlodipine 150/10 mg
Experimental
Aliskiren/Amlodipine 150/10 mg
干预措施: Amlodipine 10 mg (Drug)
Aliskiren/Amlodipine 150/10 mg
Experimental
Aliskiren/Amlodipine 150/10 mg
干预措施: Aliskiren 150 (Drug)
Aliskiren/Amlodipine 300/10 mg
Experimental
Aliskiren/Amlodipine 300/10 mg
干预措施: Amlodipine 10 mg (Drug)
Aliskiren/Amlodipine 300/10 mg
Experimental
Aliskiren/Amlodipine 300/10 mg
干预措施: Amlodipine 300 (Drug)
结局指标
主要结局
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study
时间窗: Baseline and Week 8
次要结局
- Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group(8 weeks)
- Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study(Baseline and Week 8)
- Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS)(12 weeks)
研究者
研究点 (1)
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