A Randomized, Double-Blind, Active-Controlled Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk and Not Adequately Controlled With Atorvastatin: A Comparison of Switching to a Combination Tablet Ezetimibe/Simvastatin Versus Doubling the Baseline Dose of Atorvastatin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 主要终点
- Percent Change From Baseline in Low Density Lipoprotein (LDL)-C
研究概览
简要总结
Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40). After 6 weeks of treatment, the percent reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared between the two treatment groups.
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
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who are either statin naive or on approved lipid lowering therapy for 6 weeks prior to study initiation
- •Participant meets Adult Treatment Panel (ATP) III High Risk criteria
排除标准
- •Females who are pregnant or breastfeeding
- •Participant consumes more than 14 alcoholic beverages per week
- •Participant has been treated with an investigational drug within the last 30 days
- •Participant has congestive heart failure (New York Heart Association [NYHA] Type III or IV)
- •Participant has had gastric bypass
- •Participant is newly diagnosed with type 1 or 2 diabetes
- •Participant is Human Immunodeficiency Virus (HIV) positive
- •Participant has a history of drug or alcohol abuse within the last 5 years
研究组 & 干预措施
ezetimibe/simvastatin 10/40
Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period
干预措施: ezetimibe/simvastatin 10/40 (Drug)
ezetimibe/simvastatin 10/40
Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period
干预措施: atorvastatin 20 mg (Drug)
atorvastatin 40 mg
Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period
干预措施: atorvastatin 20 mg (Drug)
atorvastatin 40 mg
Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period
干预措施: atorvastatin 40 mg (Drug)
结局指标
主要结局
Percent Change From Baseline in Low Density Lipoprotein (LDL)-C
时间窗: Baseline (Treatment Day 1), Treatment Week 6
次要结局
- Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol(Baseline (Treatment Day 1), Treatment Week 6)
- Percent Change From Baseline in LDL-Cholesterol/HDL-Cholesterol Ratio(Baseline (Treatment Day 1), Treatment Week 6)
- Percent Change From Baseline in Triglycerides(Baseline (Treatment Day 1), Treatment Week 6)
- Percent Change From Baseline in Apolipoprotein B(Baseline (Treatment Day 1), Treatment Week 6)
- Percent Change From Baseline in Apolipoprotein A-1(Baseline (Treatment Day 1), Treatment Week 6)
- Percent Change From Baseline in Apolipoprotein B/A-1 Ratio(Baseline (Treatment Day 1), Treatment Week 6)
- Number of Participants Reaching LDL-C Target Goal <77 mg/dL(Treatment Week 6)
- Number of Participants Reaching LDL-C Target Goal <100 mg/dL(Treatment Week 6)
- Percent Change From Baseline in Non-HDL Cholesterol(Baseline (Treatment Day 1), Treatment Week 6)
- Percent Change From Baseline in Total Cholesterol/HDL-Cholesterol Ratio(Baseline (Treatment Day 1), Treatment Week 6)
- Number of Participants Reaching LDL-C Target Goals of <70 mg/dL(Treatment Week 6)
- Percent Change From Baseline in Total Cholesterol(Baseline (Treatment Day 1), Treatment Week 6)
- Percent Change From Baseline in Non-HDL Cholesterol/HDL-Cholesterol Ratio(Baseline (Treatment Day 1), Treatment Week 6)
- Percent Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)(Baseline (Treatment Day 1), Treatment Week 6)