NCT03210532已完成3 期
Evaluate the Efficacy and Safety of Combination Treatment With DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients With Hypertension and Dyslipidemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Change of MSSBP(Mean Sit Systolic Blood Pressure) from baseline
研究概览
简要总结
A Multicenter, Randomized, Double-blinded, Double-dummy, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment with DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients with Hypertension and Dyslipidemia
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults both male and female who are ≥19,<80 years old
- •at screening, 140mmHg≤ SBP<180mmHg & 90mmHg≤ DBP<110mmHg & LDL-C≤250mg/dL & triglyceride<400mg/dL
排除标准
- •at screening, the difference BP of one-side arm is SBP ≥ 20mmHg and DBP ≥ 10mmHg
- •secondary hypertension or secondary dyslipidemia
- •patients who have uncontrolled diabetes melitus, hyper/hypothyroidism or cardiac disease
- •women who are pregnant or lactating
研究组 & 干预措施
Test
Experimental
qd PO, Twynsta(telmisartan/amlodipine) + Crestor(rosuvastatin)
干预措施: Telmisartan + Amlodipine + Rosuvastatin (Drug)
Reference 1
Active Comparator
qd PO, Micardis(telmisartan) + Crestor(rosuvastatin)
干预措施: Telmisartan + Rosuvastatin (Drug)
Reference 2
Active Comparator
qd PO,Twynsta(telmisartan/amlodipine)
干预措施: Telmisartan + Amlodipine (Drug)
结局指标
主要结局
Change of MSSBP(Mean Sit Systolic Blood Pressure) from baseline
时间窗: 8-week
Change of LDL-C(Low Density Lipid Cholesterol) from baseline
时间窗: 8-week
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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