NCT00888355已完成3 期
A Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Investigate the Antihypertensive Efficacy and Safety of Losartan Given Once or Twice Daily in Patients With Mild to Moderate Hypertension
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
- 428
- 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
The study had a 4 week single blind placebo period followed by 12 weeks of double blind treatment. Patients were randomized to one of four treatment arms to evaluate the antihypertensive efficacy of 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
- 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
- •Patient has no treatment or active medical problem, other than hypertension that might affect the patients blood pressure
排除标准
- •Pregnant of lactating female patients
- •Secondary hypertension or history of malignant hypertension
- •Sitting systolic blood pressure > 210 mmHg
- •History of stroke
- •History of myocardial infarction with in the past year
- •Current of prior history of heart failure
- •Known hypersensitivity to losartan
- •Patients known to be HIV positive or known to be positive for Hepatitis B
- •Absence of one kidney
- •Patient is abusing or previously abused alcohol or drugs with in past two years
研究组 & 干预措施
2
Experimental
Losartan 50 q.a.m.
干预措施: losartan potassium (Drug)
3
Experimental
Losartan 25 b.i.d.
干预措施: losartan potassium (Drug)
4
Experimental
Losartan 25 q.a.m.
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 after last morning dose and 12 hours after last PM dose)
Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiDBP at Week 12
次要结局
- Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12(At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose))
- Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12(At baseline and at 12 weeks (6 hours after last morning dose))
- Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12(24 hours after last morning dose and 12 hours after last PM dose at 12 weeks)
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