Official Title: “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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Atorvastatin
  • atorvastatin 20 mg tablets, daily dosing, for 8 weeks.
• Drug: AEGR-733
  • 2.5 mg AEGR-733 capsules, daily dosing, 4 weeks followed by 5 mg AEGR-733 capsules, daily dosing, 4 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 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
• Active Comparator: 1
  • Following 35-day washout + diet run-in, subjects receive atorvastatin 20 mg for 8 wks.

Primary Measures

• Percent change in LDL-C after 8 weeks of therapy
  • Time Frame: 8 weeks of treatment
    Safety Issue?: Yes

Secondary Measures

• Percent changes in LDL-C at week 4 + baseline serum lipoproteins (TC, non-HDL, VLDL, TGs, HDL-C, apolipoproteins A1 and B), high sensitivity C-reactive protein, change in body weight,overall safety and tolerability.
  • Time Frame: 4 weeks
    Safety Issue?: Yes

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Aegerion Pharmaceuticals, Inc.

Overall Clinical Trial Officials and Contacts

Steven Belknap, MD Study Director Medical Monitor at Radiant Research  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00690443

Study ID Number: AEGR 733-006

ClinicalTrials.gov Identifier: NCT00690443

Health Authority: United States: Food and Drug Administration