Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Aegerion Pharmaceuticals, Inc.
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)