A Double-blind, Randomized, Parallel-group, Placebo-controlled Pilot Study to Investigate the Magnitude and Duration of Response and the Safety of MK0954 (50 mg Given Once or Twice Daily, or 100 mg Given Once Daily) Compared to Placebo Using Ambulatory Blood Pressure Monitoring
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 122
- 主要终点
- Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4
研究概览
简要总结
The purpose of this study was to evaluate the magnitude and durations of the antihypertensive effects of losartan using ambulatory blood pressure monitoring (ABPM), and to evaluate the safety of losartan 50 and 100 mg doses compared to placebo.
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
- •Non-black men and women with mild to moderate hypertension and within 30% of their ideal body weight
- •Patient is in good general health
- •Blood pressure at time of randomization is 95-115 mm Hg
排除标准
- •Secondary Hypertension or history of malignant hypertension
- •History of stroke
- •History of myocardial infarction
- •Atrial flutter or atrial fibrillation
- •History of congestive Heart failure
- •Patient taking major psychotropic agent or anti-depressant
- •Patient regularly uses NSAIDS or high dose aspirin
- •Known positive test for HIV/AIDS or Hepatitis B
- •Patient is being treated for acute ulcer disease
- •Prior exposure to losartan
- •Actively treated diabetes mellitus
- •History of chronic liver disease
- •Actively treated diabetes mellitus
- •Any known bleeding or platelet disorder
- •Absence of one kidney
- •Women of childbearing potential
- •Alcoholism or drug addiction
研究组 & 干预措施
3
losartan 100 mg q.d.
干预措施: hydrochlorothiazide (HCTZ) (Drug)
1
Placebo
干预措施: hydrochlorothiazide (HCTZ) (Drug)
2
losartan 50 mg q.d.
干预措施: losartan potassium (Drug)
2
losartan 50 mg q.d.
干预措施: hydrochlorothiazide (HCTZ) (Drug)
3
losartan 100 mg q.d.
干预措施: losartan potassium (Drug)
4
losartan 50 mg b.i.d.
干预措施: losartan potassium (Drug)
4
losartan 50 mg b.i.d.
干预措施: hydrochlorothiazide (HCTZ) (Drug)
结局指标
主要结局
Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4
时间窗: 24 hour period at Baseline and Week 4
Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4
时间窗: 24-hour period at baseline and Week 4
次要结局
- Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6(Baseline and 24-hours after morning dose at Week 6)
- Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4(Baseline and 24-hours after morning dose at Week 4)
- Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6(Baseline and 24-hours after morning dose at Week 6)