A Randomized, Double Blind Comparator-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of the Combination of AEGR-733 and Atorvastatin 20 mg vs Atorvastatin Monotherapy in Subjects With Moderate Hypercholesterolemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 5
- 主要终点
- Percent Change in LDL-C After 8 Weeks of Therapy
研究概览
简要总结
Evaluate the efficacy of combination therapy AEGR-733 plus atorvastatin 20 mg versus monotherapy on serum lipoproteins over 4 and 8 weeks of therapy. The primary efficacy parameter is percent change in LDL-C after 8 weeks of therapy.
详细描述
Following a 35-day washout of current lipid-lowering medication (if any) and adherence to a low-fat diet, subjects will receive either atorvastatin 20 mg for 8 weeks, OR AEGR-733 2.5 mg + atorvastatin 20 mg for 4 weeks followed by AEGR-733 5 mg + atorvastatin 20 mg for 4 additional weeks. During the entire study, subjects will be instructed to follow a low-fat/low cholesterol diet and limit alcohol consumption to -/< 1 drink per day.
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
- 是
入选标准
- •M/F 18-70
- •0-1 risk factor, mean LDL-C -/> 160 and -/< 250 mg/dL (Visit 2 & 3)
- •2+ risk factors, mean LDL-C -/> 130 & -/< 250 mg/dL (Visit 2 & 3)
- •Fasting mean TGs -/< 400 mg/dL
- •Understanding and compliance of protocol
- •sign consent
排除标准
- •Females pregnant, lactating, or CBP who have not been using acceptable contraceptive methods over previous 3 months
- •Uncontrolled hypertension >180/95 at screening
- •Hx of chronic renal insufficiency (serum creatinine > 2.5 mg/dL)
- •Hx of liver disease or transaminases > 1.5 X ULN
- •Positive for Hepatitis B or C
- •Major surgery within past 3 mos
- •Cardiac insufficiency defined as functional Class II-Class IV
- •Hx of malignancy within previous 5 years
- •Participation in another investigational drug study within past 6 wks
- •Serious or unstable medical or psychological condition
- •Regular alcohol use > 1 drink per day
- •Regular consumers of grapefruit juice or medications known to be metabolized by CYP 3A4
- •Use of other lipid-lowering meds (washout permitted)
- •Acute CVD
- •Diabetes Mellitus
- •Fasting glucose >110 mg/dL
- •BMI -/> 40 kg/m2
- •Significant gastrointestinal symptoms such as IBS
- •Use of fish oils, niacin, herbal wt. loss products (washout permitted)
研究组 & 干预措施
2
2.5 mg AEGR 733 plus atorvastatin 20 mg weeks 1-4 followed by 5 mg AEGR 733 plus atorvastatin 20 mg weeks 5-8
干预措施: AEGR-733 (Drug)
1
Following 35-day washout + diet run-in, subjects receive atorvastatin 20 mg for 8 wks.
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Percent Change in LDL-C After 8 Weeks of Therapy
时间窗: Baseline and 8 weeks of treatment
次要结局
- Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight.(Baseline and 4 weeks)