NCT00543413已完成2 期
A Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Study to Assess the Efficacy and Tolerability of MK8141 in Hypertensive Patients
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
- 160
- 主要终点
- To measure the tolerability and effectiveness of MK8141 in lowering 24-hour mean ambulatory blood pressure versus placebo after 4 weeks of treatment.
研究概览
简要总结
This study will evaluate the effectiveness and tolerability of MK8141 in lowering blood pressure in patients who have hypertension (high blood pressure).
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 (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •You are 35 to 65 years of age
- •In the past 14 days you have not been treated for hypertension
- •In the past 14 days you have not taken more than 2 medications to treat high blood pressure
- •You are a woman who is not able to have children or do not use birth control
排除标准
- •You are taking more than 2 medications to treat high blood pressure
- •You have a history of a stroke, transient ischemic attack (TIA), heart attack, congestive heart failure, coronary artery bypass surgery
- •You have Type 1 or 2 diabetes mellitus
- •You have an active liver disease, gallbladder disease, or bowel disease
- •You are HIV positive
- •You have certain types of cancer
- •You abuse drug or alcohol
- •You have participated in another clinical study in last 4 weeks
研究组 & 干预措施
1
Experimental
Arm 1: Drug 250 mg
干预措施: MK8141 (Drug)
2
Experimental
Arm 2: Drug 500 mg
干预措施: MK8141 (Drug)
3
Active Comparator
Arm 3: Active Comparator
干预措施: Enalapril (Drug)
结局指标
主要结局
To measure the tolerability and effectiveness of MK8141 in lowering 24-hour mean ambulatory blood pressure versus placebo after 4 weeks of treatment.
时间窗: after 4 weeks of treatment
次要结局
- Compare MK8141 versus placebo in lowering 24-hour mean sitting blood pressure by ambulatory blood pressure monitoring and in lowering trough mean sitting diastolic and systolic blood pressure after 4 weeks of treatment.(after 4 weeks of treatment)
研究者
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