NCT00444834终止2 期
A Phase II, Multi-center, Multiple-dose, Double-blind, Randomized, Crossover Study Comparing the Pharmacodynamic Effects of a Once-daily Controlled-Release Carvedilol (CRC; Egalet® Formulation) and an Immediate-Release Carvedilol (IRC) Formulation in Patients With Primary Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Egalet Ltd
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- The change from baseline to 3 weeks treatment in systolic blood pressure at the end of five minutes of sub-maximal exercise
研究概览
简要总结
The purpose of this study is to compare the efficacy of the Egalet® controlled release formulation to an immediate release Carvedilol tablet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Have a diagnosis of mild or moderate primary hypertension
- •Be able to tolerate a 2 week washout phase followed by a 2 week Placebo run- in phase
- •Be minimum 18 years of age
排除标准
- •Be intolerant to alfa- or beta-blockers
- •Have secondary causes of hypertension
- •Be taking more than two antihypertensive medications
研究组 & 干预措施
2
Active Comparator
Coreg
干预措施: Carvedilol (Drug)
1
Experimental
Egalet carvedilol
干预措施: Carvedilol (Drug)
结局指标
主要结局
The change from baseline to 3 weeks treatment in systolic blood pressure at the end of five minutes of sub-maximal exercise
时间窗: 15w
次要结局
- The change in Heart Rate from baseline to 3 weeks treatment measured at the end of five minutes of sub-maximal exercise(15w)
- Safety(15w)
研究者
研究点 (2)
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