NCT01764295已完成3 期
Multi-institutional, Randomized, Double-Blind, Placebo-Control, Factorial Design, 4-arms, 8 Week Administration, Phase 3 Clinical Study for Patients With Hypertension Associated With Dyslipidemia
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年9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
- 150
- 试验地点
- 1
- 主要终点
- LDL-C percent change of DWJ1276 from baseline
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of DWJ1276
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female in between ages of 20 and 80 at the time of screening
- •Subject who can understand information provided and who can sign written consent voluntarily
排除标准
- •Patients with hypersensitivity to olmesartan and rosuvastatin
- •Pregnant or lactating women and fertile women who is not using proper contraceptive method
- •Patient with history of drug or alcohol abuse
研究组 & 干预措施
DWJ1276
Experimental
Once daily, administered orally, 8 week
干预措施: DWJ1276 (Drug)
Olmesartan
Active Comparator
Once daily, administered orally, 8 week
干预措施: Olmesartan (Drug)
Rosuvastatin
Active Comparator
Once daily, administered orally, 8 week
干预措施: Rosuvastatin (Drug)
Placebo
Placebo Comparator
Once daily, administered orally, 8 week
干预措施: Placebo (Drug)
结局指标
主要结局
LDL-C percent change of DWJ1276 from baseline
时间窗: 8weeks
DBP change of DWJ1276 from baseline
时间窗: 8weeks
次要结局
- Proportion of subjects who reached LDL-C treatment goal defined by NCEP ATP III guideline(8weeks)
- Proportion of subjects who reached blood pressure treatment goal defined by JNC VII report(8weeks)
研究者
研究点 (1)
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