Multi-center Open Label, Non-comparative Observational Study of Irbesartan-Hydrochlorothiazide in the Treatment of Hypertension in Chinese Population
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 968
- 试验地点
- 1
- 主要终点
- Proportion of patients who reach a diastolic blood pressure <85 mmHg
研究概览
简要总结
To analyse the control rate of irbesartan/hydrochlorothiazide(HCTZ) (COAPROVEL) in the treatment of patients with mild to moderate primary hypertension.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
4 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg followed by:
- If DBP<85mmHg: 4 weeks of one tablet of Irbesartan 150mg / Hydrochlorothiazide 12.5mg
- If DBP≥85mmHg: 4 weeks of one tablet of Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet of Irbesartan 150mg
干预措施: Irbesartan 150mg / Hydrochlorothiazide 12.5mg (Drug)
1
4 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg followed by:
- If DBP<85mmHg: 4 weeks of one tablet of Irbesartan 150mg / Hydrochlorothiazide 12.5mg
- If DBP≥85mmHg: 4 weeks of one tablet of Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet of Irbesartan 150mg
干预措施: Irbesartan 150mg (Drug)
2
2 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg followed by 2 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet Irbesartan 150mg followed by:
- If DBP<85mmHg: 4 weeks of of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet Irbesartan 150mg
- If DBP≥85mmHg: 4 weeks of two tablets Irbesartan 150mg / Hydrochlorothiazide 12.5mg
干预措施: Irbesartan 150mg / Hydrochlorothiazide 12.5mg (Drug)
2
2 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg followed by 2 weeks of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet Irbesartan 150mg followed by:
- If DBP<85mmHg: 4 weeks of of one tablet Irbesartan 150mg / Hydrochlorothiazide 12.5mg + one tablet Irbesartan 150mg
- If DBP≥85mmHg: 4 weeks of two tablets Irbesartan 150mg / Hydrochlorothiazide 12.5mg
干预措施: Irbesartan 150mg (Drug)
结局指标
主要结局
Proportion of patients who reach a diastolic blood pressure <85 mmHg
时间窗: At 2, 4 and 8 weeks
次要结局
未报告次要终点