A Randomized, Double-blind, Multicenter Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administration of DWC202206 and DWC202207 in Patients With Hypertension and Dyslipidemia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 192
- 主要终点
- The change of LDL-C based on baseline between treatment arm and control 2 arm
研究概览
简要总结
This study aims to evaluate the efficacy and safety of co-administration of DWC202206 and DWC202207 in patients with concomitant hypertension and hyperlipidemia.
详细描述
The study design is a randomized, double-blind, multicenter clinical trial. The patients were randomly assigned to each group. Primary endpoint was the change of MSSBP based on baseline between Treatment arm and control 1 arm and the change of LDL-C based on baseline between arm and control 2 arm.
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 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
(D) DWC202206 + DWC202207
干预措施: (D) DWC202206 (Drug)
(D) DWC202206 + DWC202207
干预措施: (D) DWC202207 (Drug)
(P+D) DWC202206 + DWC202207
干预措施: (D) DWC202207 (Drug)
(P+D) DWC202206 + DWC202207
干预措施: (P) DWC202206 (Drug)
(D+P) DWC202206 + DWC202207
干预措施: (D) DWC202206 (Drug)
(D+P) DWC202206 + DWC202207
干预措施: (P) DWC202207 (Drug)
结局指标
主要结局
The change of LDL-C based on baseline between treatment arm and control 2 arm
时间窗: 8 weeks
The change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline between treatment arm and control 1 arm
时间窗: 8 weeks
次要结局
- The change of LDL-C based on baseline between treatment arm and control 2 arm(4 weeks)
- The change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline between treatment arm and control 1 arm(4 weeks)