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

Phase 2

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: AEGR-733 5 mg; Drug: AEGR-733 10 mg; Drug: AEGR-733 5 mg + atorvastatin 20 mg; Drug: Atorvastatin 20 mg; Drug: Placebo; Drug: AEGR-733 10 mg + atorvastatin 20 mg

• Registration Number: NCT00474240
• Lead Sponsor: Aegerion Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Recent studies suggest more intensive cholesterol lowering treatment for people at very high risk of a heart attack, specifically for patients who have heart disease plus major risk factors. Available medications used alone at even the highest approved doses are not expected to reach these new target recommendations for cholesterol in a large number of subjects. Thus, the development of new medications that can provide additional cholesterol lowering may be beneficial.

This study tests the effectiveness of different doses of the study drug, AEGR-733 alone and in combination with the approved cholesterol lowering drug, atorvastatin (Lipitor), on cholesterol. Volunteers will be randomized to one of 6 different study treatments and will take the assigned medication (3 capsules daily) for 8 weeks.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-05-14
• Study First Submitted QC: 2007-05-14
• Study First Posted: 2007-05-16
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2013-01
• Results First Submitted: 2013-01-18
• Results First Submitted QC: 2013-01-18
• Results First Posted: 2013-02-21
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	AEGR-733 5 mg	-
4	AEGR-733 10 mg	-
5	AEGR-733 5 mg + atorvastatin 20 mg	-
2	Atorvastatin 20 mg	-
1	Placebo	-
6	AEGR-733 10 mg + atorvastatin 20 mg	-

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in LDL-C at 8 Weeks	Atfer 8 weeks on study drug

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline of Other Lipids	After 8 weeks of study drug

Trial Locations

Locations (17)

Sterling Research Group; 🇺🇸 Cincinnati, Ohio, United States

National Clinical Research; 🇺🇸 Richmond, Virginia, United States

Coastal Carolina Research Center; 🇺🇸 Goose Creek, South Carolina, United States

Hampton Roads Center for Clinical Research; 🇺🇸 Norfolk, Virginia, United States

Maine Research Associates; 🇺🇸 Auburn, Maine, United States

Piedmont Medical Research Associates; 🇺🇸 Winston-Salem, North Carolina, United States

North Georgia Clinical Research; 🇺🇸 Woodstock, Georgia, United States

Midwest Institute for Clinical Research; 🇺🇸 Indianapolis, Indiana, United States

Health Trends Research; 🇺🇸 Baltimore, Maryland, United States

Renstar Medical Research; 🇺🇸 Ocala, Florida, United States

Medsphere Medical Research Center; 🇺🇸 Evansville, Indiana, United States

Jacksonville Center for Clinical research; 🇺🇸 Jacksonville, Florida, United States

Diabetes and Glandular Disease Research; 🇺🇸 Dallas, Texas, United States

Medical Affiliated Research Center; 🇺🇸 Huntsville, Alabama, United States

Dallas Diabetes and Endocrine Center; 🇺🇸 Dallas, Texas, United States

Jacksonville Center For Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Radiant Research; 🇺🇸 Chicago, Illinois, United States