NCT00887250已完成3 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan (MK954, DuP753) in Patients With Mild to
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
- 366
- 主要终点
- Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
研究概览
简要总结
After a 4 week placebo period, patients were randomized to Placebo or Losartan 50 mg arms, after 6 weeks non-responders were up titrated to 100 mg losartan for the remaining 6 weeks. This study evaluated if losartan is more effective than placebo in lowering sitting diastolic blood pressure and is well tolerated in patients with mild to moderate hypertension.
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 (SDBP 95-115 mm Hg)
- •Patient has no medical problems or treatments that might effect their blood pressure
排除标准
- •Pregnant or lactating females
- •Patient has secondary hypertension or malignant hypertension
- •Sitting systolic blood pressure > 210 mm Hg
- •History of stroke
- •History of myocardial infarction with in past year
- •Current or prior history of heart failure
- •Known hypersensitivity to losartan
- •Prior exposure to losartan
- •Patients known to be HIV positive
- •Patient is abusing or has abused alcohol or other drugs within the past 4 years
研究组 & 干预措施
2
Experimental
Losartan 50 mg for 12 weeks
干预措施: losartan potassium (Drug)
结局指标
主要结局
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
时间窗: At baseline and at 12 weeks (24 hours post dose)
Mean change from baseline in trough (24 hours post dose) SiDBP at Week 12
次要结局
- Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6(24 hours post dose at Week 6)
- Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12(24 hours post dose at Week 12)
- Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 6(At baseline and at 6 weeks (24 hours post dose))
- Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 6(At baseline and at 6 weeks (24 hours post dose))
- Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12(At baseline and at 12 weeks (6 hours post dose))
研究者
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