A Multicenter, Randomized, Double-Blind, Titration Study to Evaluate the Efficacy and Safety of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia at Risk for Coronary Heart Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 440
- 主要终点
- Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment
研究概览
简要总结
A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in participants treated with rosuvastatin alone and not at their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) LDL-C goal
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
- •Participant is currently taking a stable dose of lipid lowering agent(s). (if applicable) or is statin naive
- •Participant is currently taking a stable dose of lipid lowering agent(s). (if is at least moderate high risk for Coronary Heart Disease (CHD))
- •Participant is currently taking a stable dose of lipid lowering agent(s). (if is willing to maintain Therapeutic Lifestyle Changes (TLC) / American Diabetes Association(ADA) diet)
排除标准
- •Participant weighs less than 100 lbs (45 kg).
- •Participant has hypersensitivity or intolerance to ezetimibe, or rosuvastatin or any components of these medications.
- •If female, participant is pregnant or breastfeeding.
- •Participant consumes more than 2 alcoholic beverages per day.
- •Participant has been in a clinical trial within the last 30 days.
- •Participant has heart problems such as CHF, unstable angina or heart attack.
- •Participant has type 1 or 2 diabetes and has changed their medication in the last 2 months.
- •Participant has liver disease.
- •Participant is Human Immunodeficiency Virus (HIV) positive.
- •Participant has a history of drug or alcohol abuse in the last year.
研究组 & 干预措施
Rosuvastatin 20 mg
Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
干预措施: Comparator: rosuvastatin 20 mg (Drug)
Rosuvastatin 5 mg + Ezetimibe 10 mg
Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
干预措施: Comparator: rosuvastatin 5 mg + ezetimibe 10 mg (Drug)
Rosuvastatin 10 mg
Participants who received rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
干预措施: Comparator: rosuvastatin 10 mg (Drug)
Rosuvastatin 10 mg + Ezetimibe 10 mg
Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
干预措施: Comparator: rosuvastatin 10 mg + ezetimibe 10 mg (Drug)
结局指标
主要结局
Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment
时间窗: Baseline to 6 weeks
The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment in participants who were administered ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.
次要结局
- Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum(Baseline to 6 weeks)
- Number of Participants Who Reached Their Target LDL-C Level(6 weeks of treatment)
- Number of Participants Who Reached the LDL-C Level of <70 mg/dl(6 weeks of treatment)
- Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl(6 weeks of treatment)
- Number of Participants in Each Stratum Who Reached Their Target LDL-C Level(6 weeks of treatment)
- Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels(Baseline to 6 weeks)