NCT00562809已完成4 期
A Multicenter, Open-Label Study Assessing the Efficacy and Safety of Irbesartan 150/12.5 mg and 300/25 mg in Patients With Hypertension Not Controlled by Monotherapy
适应症
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
- 1,005
- 试验地点
- 1
- 主要终点
- Change in the mean SBP
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of Irbesartan 150/12.5 mg and 300/25 mg in patients with hypertension not controlled by monotherapy.
详细描述
The primary and secondary endpoints applied to sub-groups defined by age, race, diabetes, metabolic syndrome and prior HTN therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have hypertension and uncontrolled SBP on monotherapy.
- •Patients who have read, signed and received a copy of the informed consent prior to any study procedures
- •Note: Female patients must be post-menopausal for one year, surgically sterilized, or using a medically accepted method of contraception (intrauterine device, oral contraceptives, barrier method with spermicide) and must agree to use an effective method of contraception throughout the study.
排除标准
- •Any history of secondary hypertension
- •History of hypertensive encephalopathy, stroke, or transient ischemic attack (TIA) within the past 12 months
- •History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
结局指标
主要结局
Change in the mean SBP
时间窗: from baseline to week 18
次要结局
- Change in mean DBP(from baseline to week 18.)
- Changes in mean SBP and DBP(from baseline to week 10)
- SBP and DBP response and control rates(at weeks 10 and 18)
研究者
研究点 (1)
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