NCT00277472已完成4 期
A 28-week, Multicenter Study to Evaluate the Effects of Valsartan/Hydrochlorothiazide (160/12.5 mg) in Comparison With Hydrochlorothiazide (25 mg) Monotherapy, for the Treatment of Patients With Hypertension, Uncontrolled by Hydrochlorothiazide (12.5 mg) Monotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 4 weeks
研究概览
简要总结
This study will assess the efficacy and safety of valsartan/hydrochlorothiazide combination therapy in patients with hypertension not controlled with hydrochlorothiazide monotherapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 years of age and older
- •Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but < 180 mm Hg and mean seated diastolic blood pressure ≥ 95 mm Hg and <110 mm Hg
排除标准
- •- Patients with sever hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg
- •Diabetes with fasting glucose > 126 mg/dl or on existing anti-diabetic medication
- •History of stroke, transient ischemic attack, or myocardial infarction within the last 6 months, or diagnosed with congestive heart failure.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
valsartan HCTZ
Experimental
干预措施: Valsartan/Hydrochlorothiazide (Drug)
HCTZ
Active Comparator
干预措施: HCTZ (Drug)
结局指标
主要结局
Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 4 weeks
Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 2 weeks and 20 weeks
次要结局
- Change from baseline in systolic blood pressure after 2 weeks and 4 weeks
- Change from baseline in diastolic blood pressure after 2 weeks and 4 weeks
- Change in systolic blood pressure at 20 weeks compared to 4 weeks
- Change in diastolic blood pressure at 20 weeks compared to 4 weeks
研究者
研究点 (1)
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