NCT00159692已完成4 期
A Multi-Center, Randomized, Double-Blind, Double-Dummy Study Evaluating The Safety and Efficacy Of The Addition Of Amlodipine To Quinapril Or Losartan In The Treatment Of Diabetic Hypertensive Subjects
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.0 个研究点目标入组 739 人开始时间: 2003年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 739
- 主要终点
- The percentage of subjects that reach the JNC diabetic hypertensive BP goal of <130/80 will be assessed at Week 0 (Visit 2-Randomization), Week 5 (Visit 3), Week 9 (Visit 4), Week 15 (Visit 5) and Week 20 (Visit 6 - Final Evaluation).
研究概览
简要总结
To evaluate the percentage of subjects that reach the diabetic hypertensive blood pressure goal of <130/80 with amlodipine versus placebo in subjects initially treated with quinapril or losartan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented evidence of Type 2 diabetes as defined by the ADA guidelines and documented evidence of Hypertension (various SBP/DBP ranges).
排除标准
- •A previous history or intolerance or hypersensitivity to calcium channel blockers, ARBs or ACE inhibitors.
结局指标
主要结局
The percentage of subjects that reach the JNC diabetic hypertensive BP goal of <130/80 will be assessed at Week 0 (Visit 2-Randomization), Week 5 (Visit 3), Week 9 (Visit 4), Week 15 (Visit 5) and Week 20 (Visit 6 - Final Evaluation).
次要结局
- Percentage of subjects at SBP goal of <130 mmHg and DBP goal of <80mmHg; change from baseline blood pressures (SBP and DBP); percentage of subjects with SBP >160mmHg and/or DBP >100mmHg at Visits 2, 3, 4, 5, 6.
研究者
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