NCT01442987已完成3 期
Efficacy and Safety of Coadministered Irbesartan and Atorvastatin in Patients With Hypertension and Hyperlipidemia
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Percent change from baseline to 8 week in LDL-Cholesterol
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of coadministered Irbesartan and Atorvastatin in patients with hypertension and hyperlipidemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 19 and 75 years
- •Signed informed consent
排除标准
- •At screening, SPB ≥ 180mmHg or DBP ≥ 110mmHg or LDL-C > 250mg/dL or TG ≥ 400mg/dL
- •Has a history of hypersensitivity to Angiotensin Ⅱ receptor blocker or HMG-CoA reductase inhibitor or component of this drug
- •Has a history of multi-drug allergy
研究组 & 干预措施
Irbesartan/Atorvastatin A
Experimental
干预措施: Irbesartan/Atorvastatin A (Drug)
Irbesartan
Active Comparator
干预措施: Irbesartan (Drug)
Atorvastatin A
Active Comparator
干预措施: Atorvastatin A (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Irbesartan/Atorvastatin B
Experimental
干预措施: Irbesartan/Atorvastatin B (Drug)
Atorvastatin B
Active Comparator
干预措施: Atorvastatin B (Drug)
结局指标
主要结局
Percent change from baseline to 8 week in LDL-Cholesterol
时间窗: baseline and 8 week
Change from baseline to 8 week in Blood Pressure.
时间窗: baseline and 8 week
次要结局
- Percentage of patients reaching treatment goals according to NCEP ATP III Guideline and Blood pressure responder rate according to JNC VII Guideline.(week 8)
研究者
研究点 (1)
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