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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT00474240

Run by

Aegerion Pharmaceuticals, Inc.

People needed

157

Starts

2007-04-01

Expected to finish

2008-10-01

Last updated by the study team

2018-03-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Medical Affiliated Research Center — Huntsville, Alabama, United States
• Jacksonville Center for Clinical research — Jacksonville, Florida, United States
• Jacksonville Center For Clinical Research — Jacksonville, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• North Georgia Clinical Research — Woodstock, Georgia, United States
• Radiant Research — Chicago, Illinois, United States
• Medsphere Medical Research Center — Evansville, Indiana, United States
• Midwest Institute for Clinical Research — Indianapolis, Indiana, United States
• Maine Research Associates — Auburn, Maine, United States
• Health Trends Research — Baltimore, Maryland, United States
• Piedmont Medical Research Associates — Winston-Salem, North Carolina, United States
• Sterling Research Group — Cincinnati, Ohio, United States
• Coastal Carolina Research Center — Goose Creek, South Carolina, United States
• Dallas Diabetes and Endocrine Center — Dallas, Texas, United States
• Diabetes and Glandular Disease Research — Dallas, Texas, United States
• Hampton Roads Center for Clinical Research — Norfolk, Virginia, United States
• National Clinical Research — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.