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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00474240
First received: May 14, 2007
Last updated: January 15, 2014
Last verified: January 2013

May 14, 2007
January 15, 2014
April 2007
October 2008   (final data collection date for primary outcome measure)
Percent Change From Baseline in LDL-C at 8 Weeks [ Time Frame: Atfer 8 weeks on study drug ] [ Designated as safety issue: No ]
Percent change in LDL cholesterol at 8 weeks
Complete list of historical versions of study NCT00474240 on ClinicalTrials.gov Archive Site
Percent Change From Baseline of Other Lipids [ Time Frame: After 8 weeks of study drug ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
  • Active Comparator: 2
    Intervention: Drug: Atorvastatin 20 mg
  • Experimental: 3
    Intervention: Drug: AEGR-733 5 mg
  • Experimental: 4
    Intervention: Drug: AEGR-733 10 mg
  • Experimental: 5
    Intervention: Drug: AEGR-733 5 mg + atorvastatin 20 mg
  • Experimental: 6
    Intervention: Drug: AEGR-733 10 mg + atorvastatin 20 mg
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
157
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00474240
733-003
No
Aegerion Pharmaceuticals, Inc.
Aegerion Pharmaceuticals, Inc.
Not Provided
Not Provided
Aegerion Pharmaceuticals, Inc.
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP