Overview

AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia

Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Aegerion Pharmaceuticals, Inc.
Treatments:
Atorvastatin
Atorvastatin Calcium
Criteria
Inclusion Criteria:

1. Men and women between the ages of 18 and 70 years.

2. Elevated LDL cholesterol based on risk factors for cardiovascular disease or presence
of cardiovascular disease

Exclusion Criteria:

1. 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.

2. Uncontrolled hypertension

3. History of chronic kidney problems

4. History of liver disease

5. Positive for Hepatitis B or Hepatitis C.

6. Any major surgical procedure occurring less than 3 months ago

7. Cardiac insufficiency

8. 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.

9. Regular alcohol use >1 drink per day.

10. Regular consumers of grapefruit juice, or currently taking the following medications:
cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin,
HIV protease inhibitors, and nefazodone.

11. Use of other cholesterol lowering medications that cannot be stopped.

12. Heart attack or stroke within the previous 6 months

13. Diabetes Mellitus

14. Body mass index (BMI) ≥ 40 kg/m2.

15. Significant gastrointestinal symptoms, such as irritable bowel syndrome.

16. Current use of fish oils, niacin, and herbal weight loss products that cannot be
stopped.