NCT00882440已完成3 期
A Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Investigate the Antihypertensive Efficacy and Safety of Different Doses of DuP 753 (MK0954)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 576
- 主要终点
- Mean Change From Baseline in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8
研究概览
简要总结
The purpose of this study was to compare the antihypertensive efficacy of different doses of losartan compared to placebo and enalapril, in patients with supine diastolic blood pressure of 100-115 mmHg.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has been diagnosed with mild to moderate hypertension, with supine diastolic blood pressure of 100 to 115 mmHg
- •Patient has no active medical problems other than essential hypertension that might affect blood pressure
- •Patient has received no drug therapy that might affect blood pressure
排除标准
- •Prior exposure to losartan
- •History of stroke
- •History of myocardial infarction
- •Atrial flutter or atrial fibrillation
- •History of congestive Heart failure
- •Known Sensitivity to ACE inhibitors
- •Known positive test for HIV/AIDS or Hepatitis B
- •Patient is being treated for acute ulcer disease
- •History of chronic liver disease
- •Actively treated diabetes mellitis
- •Any known bleeding or platelet disorder
- •Absence of one kidney
- •Women of childbearing potential or who are breastfeeding
- •Patient is abusing or has a history of alcoholism or drug addiction
研究组 & 干预措施
1
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
2
Experimental
Losartan 10 mg
干预措施: losartan potassium (Drug)
3
Experimental
Losartan 25 mg
干预措施: losartan potassium (Drug)
4
Experimental
Losartan 50 mg
干预措施: losartan potassium (Drug)
5
Experimental
Losartan 100 mg
干预措施: losartan potassium (Drug)
6
Experimental
Losartan 150 mg
干预措施: losartan potassium (Drug)
7
Active Comparator
Enalapril 20 mg
干预措施: Enalapril (Drug)
结局指标
主要结局
Mean Change From Baseline in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8
时间窗: 24 hours post dose at Baseline and Week 8
次要结局
- Categories of Antihypertensive Response in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8(24 hours post dose at Week 8)
- Mean Change From Baseline in Peak Supine Diastolic Blood Pressure (SuDBP) at Week 8(6 hours post dose at Baseline and 8 weeks)
研究者
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