NCT00307060已完成3 期
A Randomized, Double-Blind, Parallel-Filter Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan-HCTZ Combination as Compared to Losartan Monotherapy in Patients With Essential Hypertension
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 274
- 主要终点
- Losartan-HCTZ 100-12.5 mg combination will be more effective in lower mean through sitting diastolic blood pressure (SiDBP) than losartan 100 mg monotherapy after 6 weeks of treatment.
研究概览
简要总结
To compare the blood pressure lowering efficacy, safety and tolerability of a combination drug to a single drug taken once daily in patients with uncontrolled blood pressure following a 4-week filter on the single therapy product.
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
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 and female patients with mild to severe hypertension (SiDBP 90-120 mmHg)
排除标准
- •Systolic BP > 200 mmHg
- •Secondary or malignant hypertension
- •Taking more than 2 antihypertensive medications
- •Hypertension induced by oral contraceptives
- •Hx of cerebral vascular accident within 6 months
- •Hx of angina, myocardial infarction, PCI, CABG, or decompensated CHF within 6 months
- •Clinically significant AV conduction disturbance or potentially life threatening ventricular arrhythmias, valvular disease, cardiomyopathy, unexplained syncope
- •History of angioedema
- •Sensitivity to AII receptor antagonists or HCTZ, nephrotic syndrome,single kidney function
- •Pregnancy or lactation.
结局指标
主要结局
Losartan-HCTZ 100-12.5 mg combination will be more effective in lower mean through sitting diastolic blood pressure (SiDBP) than losartan 100 mg monotherapy after 6 weeks of treatment.
时间窗: 6 Weeks
次要结局
- Losartan-HCTZ 100-12.5 mg combination will be more effective in lowering mean through sitting systolic blood pressure (SiSBP) after 6 weeks of treatment compared to losartan 100-mg monotherapy, and will be safe and tolerable.(6 Weeks)
研究者
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