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

Sponsored by:	Aegerion Pharmaceuticals, Inc.
Information provided by:	Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00474240

Purpose

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.

Condition	Intervention	Phase
Hypercholesterolemia	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	Phase II

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Atorvastatin Atorvastatin calcium Cholest-5-en-3-ol (3beta)- BMS201038

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Aegerion Pharmaceuticals, Inc.:

Primary Outcome Measures:

Percent change from baseline in LDL cholesterol at 8 weeks [ Time Frame: Atfer 8 weeks on study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent change from baseline of other lipids [ Time Frame: After 8 weeks of study drug ] [ Designated as safety issue: No ]

Enrollment:	157
Study Start Date:	April 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Placebo
2: Active Comparator	Drug: Atorvastatin 20 mg
3: Experimental	Drug: AEGR-733 5 mg
4: Experimental	Drug: AEGR-733 10 mg
5: Experimental	Drug: AEGR-733 5 mg + atorvastatin 20 mg
6: Experimental	Drug: AEGR-733 10 mg + atorvastatin 20 mg

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and women between the ages of 18 and 70 years.
Elevated LDL cholesterol based on risk factors for cardiovascular disease or presence of cardiovascular disease

Exclusion Criteria:

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.
Uncontrolled hypertension
History of chronic kidney problems
History of liver disease
Positive for Hepatitis B or Hepatitis C.
Any major surgical procedure occurring less than 3 months ago
Cardiac insufficiency
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.
Regular alcohol use >1 drink per day.
Regular consumers of grapefruit juice, or currently taking the following medications: cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone.
Use of other cholesterol lowering medications that cannot be stopped.
Heart attack or stroke within the previous 6 months
Diabetes Mellitus
Body mass index (BMI) ≥ 40 kg/m2.
Significant gastrointestinal symptoms, such as irritable bowel syndrome.
Current use of fish oils, niacin, and herbal weight loss products that cannot be stopped.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474240

Locations

United States, Alabama
Medical Affiliated Research Center
Huntsville, Alabama, United States, 35801
United States, Florida
Jacksonville Center For Clinical Research
Jacksonville, Florida, United States, 32216
Jacksonville Center for Clinical research
Jacksonville, Florida, United States, 32205
Renstar Medical Research
Ocala, Florida, United States, 34471
United States, Georgia
North Georgia Clinical Research
Woodstock, Georgia, United States, 30189
United States, Illinois
Radiant Research
Chicago, Illinois, United States, 60610
United States, Indiana
Medsphere Medical Research Center
Evansville, Indiana, United States, 47714
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States, 46260
United States, Maine
Maine Research Associates
Auburn, Maine, United States, 04210
United States, Maryland
Health Trends Research
Baltimore, Maryland, United States, 21209
United States, North Carolina
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Sterling Research Group
Cincinnati, Ohio, United States, 45246
United States, South Carolina
Coastal Carolina Research Center
Goose Creek, South Carolina, United States, 29445
United States, Texas
Dallas Diabetes and Endocrine Center
Dallas, Texas, United States, 75230
Diabetes and Glandular Disease Research
Dallas, Texas, United States, 78229
United States, Virginia
Hampton Roads Center for Clinical Research
Norfolk, Virginia, United States, 23502
National Clinical Research
Richmond, Virginia, United States, 23294

Sponsors and Collaborators

Aegerion Pharmaceuticals, Inc.

More Information

Publications:

Cuchel M, Bloedon LT, Szapary PO, Kolansky DM, Wolfe ML, Sarkis A, Millar JS, Ikewaki K, Siegelman ES, Gregg RE, Rader DJ. Inhibition of microsomal triglyceride transfer protein in familial hypercholesterolemia. N Engl J Med. 2007 Jan 11;356(2):148-56.

Responsible Party:	Aegerion Pharmaceuticals ( William J Sasiela PhD Chief Medical Officer )
Study ID Numbers:	733-003
Study First Received:	May 14, 2007
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00474240
Health Authority:	United States: Food and Drug Administration

Keywords provided by Aegerion Pharmaceuticals, Inc.:

cholesterol

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Metabolic disorder
Hypercholesterolemia

Atorvastatin
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009