NCT00670566已完成4 期
Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe 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
- 发起方
- Sanofi
- 入组人数
- 503
- 试验地点
- 1
- 主要终点
- Number of patients with controlled blood pressure
研究概览
简要总结
The primary objective is to evaluate the antihypertensive efficacy of a fixed combination of Irbesartan/HydroChloroThiazide (CoAprovel) in Chinese moderate to severe hypertensive patients.
The secondary objective is to get systolic blood pressure and diastolic blood pressure goal attainment rate from CoAprovel in Chinese hypertensive patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Essential hypertensive patients
- •Moderate to severe Patients with uncontrolled blood pressure (systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg for untreated, systolic blood pressure ≥150mmHg, diastolic blood pressure ≥95mmHg for treated on monotherapy).
- •Patients are willing to discontinue previous antihypertensive medicine
排除标准
- •Pregnant or lactating women, or women of child bearing potential without contraceptive method.
- •Hypersensitivity to any component of the products or other sulfonamide derived substances.
- •Secondary hypertension.
- •Severe renal impairment (Creatinine Clearance ≤30ml/min)
- •Severe hepatic impairment, biliary cirrhosis and cholestasis.
- •Refractory hypokalemia, hypercalcaemia.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
干预措施: irbesartan/hydrochlorothiazide (Drug)
结局指标
主要结局
Number of patients with controlled blood pressure
时间窗: At month 3
次要结局
- Adverse events(Throughout the study period)
- Systolic and Diastolic Blood Pressure(At month 3 versus baseline)
研究者
研究点 (1)
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