NCT00439738已完成4 期
A 16-week Double-blind, Randomized, Multicenter, Force-titration Study to Evaluate the Antihypertensive Efficacy of Valsartan/Hydrochlorothiazide (HCTZ) Therapy Compared to HCTZ Based Therapy in Obese, Hypertensive Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 412
- 试验地点
- 5
- 主要终点
- Change in Mean Sitting Systolic Blood Pressure (MSSBP)
研究概览
简要总结
The purpose of this study is to compare the blood pressure lowering efficacy of valsartan/hydrochlorothiazide (HCTZ) compared to hydrochlorothiazide for the treatment of obese hypertensive (mean sitting systolic blood pressure [MSSBP] >150 mmHg) patients.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years of age or older
- •Moderate or severe high blood pressure defined as systolic blood pressure (the top number) greater than or equal to 150 mmHg and diastolic blood pressure (the bottom number) less then 110 mmHg
- •Central (abdominal) obesity
排除标准
- •Systolic blood pressure (the top number) greater than or equal to 180 mmHg and diastolic blood pressure (the bottom number) greater than or equal to 110 mmHg
- •Currently taking more then 3 medications to treat high blood pressure
- •Inability to stop all current blood pressure medications if any up to 4 weeks
- •History of Type 1 or Type 2 diabetes
- •History of stroke, mini-stroke (transient ischemic attack) or heart attack within the last 6 months
- •History of or current diagnosis of congestive heart failure
- •History of cancer within the past 5 years with the exception of localized basal cell carcinoma or squamous cell carcinoma
- •Women who are pregnant or nursing
- •Alcohol or drug abuse within the last 2 years
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
valsartan/HCTZ
Experimental
干预措施: Valsartan/HCTZ (Drug)
HCTZ +Amlodipine
Active Comparator
干预措施: HCTZ + Amlodipine (Drug)
结局指标
主要结局
Change in Mean Sitting Systolic Blood Pressure (MSSBP)
时间窗: Baseline to Week 8
次要结局
- Change in Mean Sitting Diastolic Blood Pressure (MSDBP)(Baseline to Weeks 4, 8, 12 and 16)
- Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)(Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16))
- Change From Baseline in Postprandial Insulin(Week 16)
- Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)(Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16))
- Change From Baseline in Postprandial Glucose(Week 16)
- Change From Baseline in Postprandial Non-esterified Fatty Acids(Week 16)
研究者
研究点 (5)
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