NCT00474240

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

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of the Combination of AEGR-733 (Formerly BMS201038) and Atorvastatin 20 mg vs. Monotherapy in Subjects With Moderate Hypercholesterolemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Aegerion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Atorvastatin 20 mg
DRUG	AEGR-733 5 mg
DRUG	AEGR-733 10 mg
DRUG	Placebo
DRUG	AEGR-733 5 mg + atorvastatin 20 mg
DRUG	AEGR-733 10 mg + atorvastatin 20 mg

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-05-16
• Last updated: 2018-03-20
• Results posted: 2013-02-21

Locations

17 sites across 1 country: United States