Conditions: Hypercholesterolemia
Keywords: Hyperlipidemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 44
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 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 arm 2: Following 35-day washout + diet run-in, subjects receive atorvastatin 20 mg for 8 wks.

Interventions: intervention 1: Atorvastatin intervention 2: AEGR-733
Intervention descriptions: intervention 1: atorvastatin 20 mg tablets, daily dosing, for 8 weeks. intervention 2: 2.5 mg AEGR-733 capsules, daily dosing, 4 weeks followed by 5 mg AEGR-733 capsules, daily dosing, 4 weeks

Protocol document: