A Double-blind, Randomized, Multi-center Phase III Clinical Trial to Investigate the Safety and Efficacy Between YH16410 Versus Rosuvastatin and Telmisartan Monotherapies in Patients With Hypertension and Hyperlipidemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Change in Diastolic Blood Pressure, Change in LDL Cholesterol
研究概览
简要总结
To evaluate efficacy and safety of YH16410 versus rosuvastatin and telmisartan monotherapies in patients with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •Men and women ≥ 19 years of age
- •Subject who has one of 3 conditions classified by Cardiovascular Risk Factors, 10-Year Risk, Blood Pressure, LDL-C, TG, Coronary Artery Disease and Equivalent
排除标准
- •Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study.
- •Other exclusions applied
研究组 & 干预措施
YH16410
PO, Once Daily, 8 weeks
干预措施: YH16410 (Drug)
YH16410
PO, Once Daily, 8 weeks
干预措施: Rosuvastatin placebo (Drug)
YH16410
PO, Once Daily, 8 weeks
干预措施: Telmisartan placebo (Drug)
Rosuvastatin
PO, Once Daily, 8 weeks
干预措施: Rosuvastatin (Drug)
Rosuvastatin
PO, Once Daily, 8 weeks
干预措施: YH16410 placebo (Drug)
Rosuvastatin
PO, Once Daily, 8 weeks
干预措施: Telmisartan placebo (Drug)
Telmisartan
PO, Once Daily, 8 weeks
干预措施: Telmisartan (Drug)
Telmisartan
PO, Once Daily, 8 weeks
干预措施: YH16410 placebo (Drug)
Telmisartan
PO, Once Daily, 8 weeks
干预措施: Rosuvastatin placebo (Drug)
Placebo
PO, Once Daily, 8 weeks
干预措施: YH16410 placebo (Drug)
Placebo
PO, Once Daily, 8 weeks
干预措施: Rosuvastatin placebo (Drug)
Placebo
PO, Once Daily, 8 weeks
干预措施: Telmisartan placebo (Drug)
结局指标
主要结局
Change in Diastolic Blood Pressure, Change in LDL Cholesterol
时间窗: Change from Baseline at 8 weeks
次要结局
未报告次要终点