A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 265
- 试验地点
- 1
- 主要终点
- the change of LDL-C based on baseline between Treatment arm and control2 arm
研究概览
简要总结
A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy and safety of Olmesartan/Amlodipine/Rosuvastatin combination treatment in patients with concomitant hypertension and hyperlipidemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •Age 20 to 80 years
- •patients with hypertension and hyperlipidemias
排除标准
- •orthostatic hypotension
- •History of ventricular tachycardia, atrial fibrillation
- •uncontrolled diabetes mellitus
研究组 & 干预措施
Amlodpine, Olmesartan, Rosuvastatin
co-administration of Olmesartan, Amlodipine and Rosuvastatin
干预措施: Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg (Drug)
Olmesartan, Rosuvastatin
co-administration of Olmesartan and Rosuvastatin
干预措施: Olmesartan 40 mg, Rosuvastatin 20mg (Drug)
Amlodipine, Olmesartan
co-administration of Amlodipine and and Olmesartan
干预措施: Amlodipine/Olmesartan 10/40mg (Combination drug) (Drug)
结局指标
主要结局
the change of LDL-C based on baseline between Treatment arm and control2 arm
时间窗: 8 weeks
the change of sitSBP based on baseline between Treatment arm and control 1 arm
时间窗: 8 weeks
次要结局
未报告次要终点