Cardiovascular Fixed Combination Pill ASR: Pharmacodynamic Clinical Trial of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin, and Ramipril (Cardiovascular Polypill); LDL Cholesterol
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Difference in LDL-cholesterol levels between the basal and the final visit of treatment period.
研究概览
简要总结
This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of the reference products (simvastatin, ramipril, acetylsalicylic acid) Approximately 350 subjects will be screened, 266 randomized in order about 238 subjects to finish the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged ≥18 and <75 years.
- •Previously untreated or not treated with fibrates during the last 6 weeks or with any other lipid lowering drug for the last 4 weeks.
- •LDL-cholesterol ≥130 and ≤220 mg/dL.
- •Systolic blood pressure ≥120 and <160 mmHg and diastolic blood pressure ≥70 and <100 mmHg.
- •Provide written informed consent.
排除标准
- 未提供
研究组 & 干预措施
Fixed Dose Combination Pill
A fixed dose combination of acetylsalicylic acid, simvastatin, and ramipril Intervention: Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)
干预措施: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril) (Drug)
Simvastatin
Simvastatin given together with the reference drugs ramipril and acetylsalicylic acid
干预措施: Simvastatin, ramipril, acetylsalicylic acid (Drug)
结局指标
主要结局
Difference in LDL-cholesterol levels between the basal and the final visit of treatment period.
时间窗: Day 56
次要结局
- • Difference in VLDL-cholesterol levels between the basal and the final visit of treatment period.(Day 56)
- • Difference in HDL-cholesterol levels between the basal and the final visit of treatment period.(Day 56)
- • Difference in total cholesterol levels between the basal and the final visit of treatment period.(Day 56)
- • Difference in triglyceride levels between the basal and the final visit of treatment period(Day 56)