A 12-week, Double-blind, Randomized Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate / Simvastatin 145/20mg and Fenofibrate / Simvastatin 145/40mg Tablets vs. Matching Monotherapies in Dyslipidemic Subjects at High Risk of Cardiovascular Disease.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 575
- 试验地点
- 69
- 主要终点
- Percentage of Change of TG (Triglyceride)
研究概览
简要总结
This is a double-blind, randomized study designed to compare the efficacy and safety of two fixed combinations of fenofibrate / simvastatin 145/20 mg and fenofibrate / simvastatin 145/40 mg tablets vs. matching monotherapies in subjects with abnormal fat (lipids) in the blood and at high risk of cardiovascular disease. Fenofibrate is a treatment that lowers fat in blood. It is prescribed in patients with high levels of triglycerides (TG). The drug has been marketed in more than 80 countries since 1975. Simvastatin is also used for the treatment of patients with a high level of cholesterol. These have also been marketed worldwide for more than 20 years. It is important to treat high levels of fats in the blood because it has been shown that even mildly elevated level of lipids in the blood can lead to diseases of the blood vessels. It has been shown in several studies and in clinical practice that the combination of fenofibrate plus simvastatin can lead to improved effects on blood fats, compared to treatment with simvastatin or fenofibrate alone. The main objective of the study is to compare the efficacy of the two fixed-combinations (FC) -fenofibrate/simvastatin 145/20 mg tablet and fenofibrate/simvastatin 145/40 mg tablet in reducing TG and increasing high density lipoprotein cholesterol (HDL-C) versus simvastatin 20 mg or 40 mg, and in reducing low density lipoprotein cholesterol (LDL-C) versus fenofibrate 145 mg.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either gender (tentatively 50 percent females to be included and if of childbearing potential she must agree to use medically acceptable methods of contraception from the time of signing the informed consent until 7 days following administration of the last treatment or dose of study medication). Accepted contraceptive methods are implants, injectables, combined oral contraceptives, intra-uterine device or sexual abstinence.
- •between 18 (inclusive) and 80 years
- •With mixed dyslipidemia with fasting lipid results of a blood sample taken at inclusion and after at least 3 months of any statin monotherapy (excluding simvastatin 80 mg, atorvastatin 40 mg and 80 mg, rosuvastatin 20 mg and 40 mg):
- •TG higher than/equal to 1.71 mmol/L (higher than/equal to 150 mg/dL) and
- •LDL-C higher or equal to 1.81 mmol/L (higher or equal 70 mg/dL) but smaller than/equal to 3.36 mmol/L (smaller than/equal to 130 mg/dL)
- •High risk or very high risk based on known CardioVascular Disease (CVD) or type 2 diabetes or type 1 diabetes with microalbuminuria or a Systematic Coronary Risk Estimation (SCORE) chart risk ≥ 5percent
- •Aspartate aminotransferase and/or alanine aminotransferase smaller than/equal to 2 times the Upper Normal of Limit (UNL)
排除标准
- •Known hypersensitivity to fibrates or simvastatin or known photoallergic or phototoxic reactions under treatment with fibrates or ketoprofen or known allergic reactions caused by peanuts, peanuts or arachis oil or soy lecithin, or related products,
- •Pregnant or lactating women,
- •Unable or unwilling to comply with the protocol and the recommended diet,
- •Likely to withdraw from the study before its completion,
- •Having received an investigational drug or vaccine in the last 30 days before date of inclusion, or still participating in such a trial at Visit 1
研究组 & 干预措施
Fenofibrate/simvastatin 145/20 mg
干预措施: Fixed Combination of Fenofibrate/simvastatin 145/20 mg (Drug)
Simvastatin 20 mg
干预措施: Simvastatin 20 mg (Drug)
Fenofibrate 145 mg
干预措施: Fenofibrate 145 mg (Drug)
Fenofibrate/simvastatin 145/40 mg
干预措施: Fixed Combination of Fenofibrate/simvastatin 145/40 mg (Drug)
Simvastatin 40 mg
干预措施: Simvastatin 40 mg (Drug)
结局指标
主要结局
Percentage of Change of TG (Triglyceride)
时间窗: from baseline to 12 weeks of treatment
Collection and measurement of blood samples.
Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol)
时间窗: from baseline to 12 weeks of treatment
Collection and measurement of blood samples.
Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol)
时间窗: from baseline to 12 weeks of treatment
Collection and measurement of blood samples.
次要结局
- Percentage of Non-HDL (High Density Lipoprotein)-C From Baseline(12 weeks)
- Percentage of TC (Triglyceride) From Baseline(12 weeks)
- Percentage of Apolipoprotein AI From Baseline(12 weeks)
- Percentage of Apolipoprotein B From Baseline(12 weeks)
- Percentage of High-sensitivity C-reactive Protein (hsCRP) From Baseline(12 weeks)
- Percentage of Subjects Meeting Target Levels of Lipids (According to Very High or High Risk)(12 weeks)
- Adverse Events(12 weeks)
- Creatine Kinase (CK)(12 weeks)
- Alanine Aminotransferase (ALT)(12 weeks)
- Plasma Creatinine(12 weeks)
- Total Bilirubin(12 weeks)
- Cystatin C(12 weeks)