NCT01122251已完成2 期
A Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy Phase II Trial to Evaluate the Efficacy and Safety of the Combinations of Lercanidipine and Valsartan in Comparison to Each Component Administered Alone and to Determine the Optimal Dose Combinations in Patients With Essential Hypertension
LG Life Sciences2 个研究点 分布在 1 个国家目标入组 441 人开始时间: 2009年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 441
- 试验地点
- 2
- 主要终点
- sitDBP
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of fixed combination of lercanidipine (10 mg or 20 mg) and valsartan (80 mg or 160 mg), lercanidipine and valsartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 20 and 75
- •Essential hypertension at screening (-3 week)
- •Randomization Criteria:
- •Essential hypertension at baseline (90mmHg≤sitDBP≤109mmHg, except sitSBP≥180)
排除标准
- •Mean sitDBP≥110mmHg or sitSBP≥180
- •Secondary hypertension or suspected secondary hypertension
- •Uncontrolled diabetes
- •Severe heart disease or severe cerebrovascular disease
- •clinically significant hematological test results, renal disease (serum creatinine) or liver disease (ALT or AST)
- •History of malignant disease
- •Autoimmune disease
- •Women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial
研究组 & 干预措施
Lercanidipine or Valsartan
Active Comparator
L10, L20, V80, V160
干预措施: Lercanidipine or Valsartan (Drug)
Lercanidpine + Valsartan
Experimental
L10/V80, L20/V80, L10/V160, L20/V160
干预措施: Lercanidipine + Valsartan (Drug)
Placebo
Placebo Comparator
Placebo comparators of Lercanidipine and Valsartan
干预措施: Placebo (Drug)
结局指标
主要结局
sitDBP
时间窗: Baseline, Week 8
Average changes from baseline in sitDBP
次要结局
- sitDBP(Week 4)
- sitSBP(Week 4, 8)
研究者
研究点 (2)
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