NCT01093807已完成2 期
Randomized, Parallel Group, Double-blind Trial to Evaluate Different Dose Combinations of Lercanidipine and Enalapril in Comparison With Each Component Administered Alone and With Placebo in Patients With Essential Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,039
- 试验地点
- 1
- 主要终点
- Change from baseline in sitting diastolic blood pressure (SDBP)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of various dosage combinations of lercanidipine (10 and 20 mg)and enalapril (10 and 20 mg) in comparison with their respective components and with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Office Blood Pressure (BP): Sitting diastolic blood pressure (SDBP)100-109 mmHg (inclusive) and sitting systolic blood pressure (SSBP) < 180 mmHg after a 2 week placebo run-in period
- •Home Blood Pressure: diastolic blood pressure (DBP)at home ≥ 85 mmHg in the last week of the placebo run-in period
- •Normal Electrocardiogram (ECG), first degree Atrioventricular block or other changes not considered clinically significant
排除标准
- •Secondary or severe hypertension
- •History of cerebro- or cardiovascular complications
- •Type 1 or Type 2 diabetes on drug treatment
- •Severe renal or hepatic insufficiency
研究组 & 干预措施
Lercanidipine 10 mg/Enalapril 10 mg
Experimental
干预措施: Lercanidipine + Enalapril (Drug)
Lercanidipine 10mg/Enalapril 20 mg
Experimental
干预措施: Lercanidipine + Enalapril (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Lercanidipine 10 mg
Experimental
干预措施: Lercanidipine (Drug)
Lercanidipine 20 mg
Experimental
干预措施: Lercanidipine (Drug)
Enalapril 10 mg
Experimental
干预措施: Enalapril (Drug)
Enalapril 20 mg
Experimental
干预措施: Enalapril (Drug)
Lercanidipine 20mg/Enalapril 10 mg
Experimental
干预措施: Lercanidipine + Enalapril (Drug)
Lercanidipine 20mg/Enalapril20mg
Experimental
干预措施: Lercanidipine + Enalapril (Drug)
结局指标
主要结局
Change from baseline in sitting diastolic blood pressure (SDBP)
时间窗: after 10 weeks
次要结局
- Change from baseline in sitting systolic blood pressure (SSBP)(after 10 weeks)
- Safety parameters: adverse events, heart rate, laboratory tests physical examination(10 weeks)
研究者
研究点 (1)
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