NCT00289406已完成3 期
An 8 Weeks, Multi-Center, Randomized, Double Blinded, Comparative Phase 3 Clinical Trial to Assess the Efficacy and Safety of S-Amlodipine Gentisate Compared to Amlodipine Besylate in Patients With Mild-to-Moderate Hypertension
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- The difference in mean changes from baseline in through sitting diastolic blood pressure after 8 weeks of treatment
研究概览
简要总结
The goal of this study is to compare the antihypertensive effect and tolerability of S-amlodipine gentisate with those of amlodipine besylate in patients with mild to moderate 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
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
- •patients are required to have a mean cuff sitting diastolic blood pressure of ≥90 and ≤109 mmHg after successful completion of the 2-week placebo run-in period
排除标准
- •any serious disorder that could limit the ability of the patient to participate in the study
- •significant cardiovascular disease (angina, myocardial infarction, cerebrovascular disease, or significant arrhythmia in the preceding 6 months)
- •uncontrolled diabetes mellitus (serum glucose level ≥140 mg/dl)
- •insulin dependent diabetes mellitus (type I)
- •secondary hypertension
结局指标
主要结局
The difference in mean changes from baseline in through sitting diastolic blood pressure after 8 weeks of treatment
次要结局
- Mean changes in sitting systolic blood pressure; response rate (defined as the proportion of patients whose sDBP was ≤90mmHg or whose sDBP had decreased from baseline by ≥10 mmHg); changes in triglyceride and total cholesterol level of blood sample
研究者
研究点 (2)
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