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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00474240
Recruitment Status : Completed
First Posted : May 16, 2007
Results First Posted : February 21, 2013
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE May 14, 2007
First Posted Date  ICMJE May 16, 2007
Results First Submitted Date  ICMJE January 18, 2013
Results First Posted Date  ICMJE February 21, 2013
Last Update Posted Date March 20, 2018
Study Start Date  ICMJE April 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2013)
Percent Change From Baseline in LDL-C at 8 Weeks [ Time Frame: Atfer 8 weeks on study drug ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2007)
Percent change in LDL cholesterol at 8 weeks
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2007)
Percent Change From Baseline of Other Lipids [ Time Frame: After 8 weeks of study drug ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2008)
157
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2007)
286
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00474240
Other Study ID Numbers  ICMJE AEGR-733-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aegerion Pharmaceuticals, Inc.
Study Sponsor  ICMJE Aegerion Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aegerion Pharmaceuticals, Inc.
Verification Date January 2013

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