A Phase III, Randomized, Active-comparator Controlled Clinical Trial to Study the Efficacy and Safety of MK-0954A in Japanese Patients With Essential Hypertension Uncontrolled With the High Dose of Losartan Potassium
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 336
- 主要终点
- Percentage of Participants Who Experienced at Least One Adverse Event (AE)
研究概览
简要总结
This study is being conducted to evaluate the efficacy of MK-0954A in essential hypertension participants who are not adequately controlled with losartan.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MK-0954A
Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
干预措施: MK-0954A (Drug)
MK-0954A
Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
干预措施: Placebo to losartan 100 mg (Drug)
MK-0954A
Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
干预措施: Placebo to losartan 50 mg (Drug)
Losartan
Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
干预措施: Losartan (Drug)
Losartan
Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
干预措施: Placebo to MK-0954A (Drug)
Losartan
Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
干预措施: Placebo to losartan 50 mg (Drug)
结局指标
主要结局
Percentage of Participants Who Experienced at Least One Adverse Event (AE)
时间窗: 8 weeks
Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP)
时间窗: Baseline and Week 8
Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).
次要结局
- Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP)(Baseline and Week 8)