A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of the Combination of AEGR-733 (Formerly BMS201038) and Atorvastatin 20 mg vs. Monotherapy in Subjects With Moderate Hypercholesterolemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 17
- 主要终点
- Percent Change From Baseline in LDL-C at 8 Weeks
研究概览
简要总结
The purpose of this study is to test the effectiveness of the study drug, AEGR-733 alone and in combination with the medication, atorvastatin (Lipitor), on cholesterol in volunteers with moderately high cholesterol.
详细描述
Recent studies suggest more intensive cholesterol lowering treatment for people at very high risk of a heart attack, specifically for patients who have heart disease plus major risk factors. Available medications used alone at even the highest approved doses are not expected to reach these new target recommendations for cholesterol in a large number of subjects. Thus, the development of new medications that can provide additional cholesterol lowering may be beneficial.
This study tests the effectiveness of different doses of the study drug, AEGR-733 alone and in combination with the approved cholesterol lowering drug, atorvastatin (Lipitor), on cholesterol. Volunteers will be randomized to one of 6 different study treatments and will take the assigned medication (3 capsules daily) for 8 weeks.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between the ages of 18 and 70 years.
- •Elevated LDL cholesterol based on risk factors for cardiovascular disease or presence of cardiovascular disease
排除标准
- •Women who are pregnant, lactating, planning to become pregnant, or women of childbearing potential who have not successfully been using acceptable contraceptive methods over the previous 3 months, e.g., intrauterine device (IUD) and barrier method plus spermicide.
- •Uncontrolled hypertension
- •History of chronic kidney problems
- •History of liver disease
- •Positive for Hepatitis B or Hepatitis C.
- •Any major surgical procedure occurring less than 3 months ago
- •Cardiac insufficiency
- •History of a malignant cancer (other than basal cell or squamous cell carcinoma of the skin that has been removed) within the previous 5 years.
- •Regular alcohol use >1 drink per day.
- •Regular consumers of grapefruit juice, or currently taking the following medications: cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone.
- •Use of other cholesterol lowering medications that cannot be stopped.
- •Heart attack or stroke within the previous 6 months
- •Diabetes Mellitus
- •Body mass index (BMI) ≥ 40 kg/m
- •Significant gastrointestinal symptoms, such as irritable bowel syndrome.
- •Current use of fish oils, niacin, and herbal weight loss products that cannot be stopped.
研究组 & 干预措施
1
干预措施: Placebo (Drug)
2
干预措施: Atorvastatin 20 mg (Drug)
3
干预措施: AEGR-733 5 mg (Drug)
4
干预措施: AEGR-733 10 mg (Drug)
5
干预措施: AEGR-733 5 mg + atorvastatin 20 mg (Drug)
6
干预措施: AEGR-733 10 mg + atorvastatin 20 mg (Drug)
结局指标
主要结局
Percent Change From Baseline in LDL-C at 8 Weeks
时间窗: Atfer 8 weeks on study drug
次要结局
- Percent Change From Baseline of Other Lipids(After 8 weeks of study drug)