Clinical trial NCT00474240: AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Keywords: cholesterol
Lead sponsor: Aegerion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2007-05-16
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Percent Change From Baseline in LDL-C at 8 Weeks
timeFrame: Atfer 8 weeks on study drug
Secondary outcomes:
measure: Percent Change From Baseline of Other Lipids
timeFrame: After 8 weeks of study drug
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Medical Affiliated Research Center
state: Alabama
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center For Clinical Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Chicago
country: United States
facility: Radiant Research
state: Illinois
city: Evansville
country: United States
facility: Medsphere Medical Research Center
state: Indiana
city: Indianapolis
country: United States
facility: Midwest Institute for Clinical Research
state: Indiana
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Baltimore
country: United States
facility: Health Trends Research
state: Maryland
city: Winston-Salem
country: United States
facility: Piedmont Medical Research Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Sterling Research Group
state: Ohio
city: Goose Creek
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrine Center
state: Texas
city: Dallas
country: United States
facility: Diabetes and Glandular Disease Research
state: Texas
city: Norfolk
country: United States
facility: Hampton Roads Center for Clinical Research
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research
state: Virginia
Study officials:
References:
citation: 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. doi: 10.1056/NEJMoa061189.