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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Placebo; Drug: Atorvastatin 20 mg; Drug: AEGR-733 5 mg; Drug: AEGR-733 10 mg; Drug: AEGR-733 5 mg + atorvastatin 20 mg; 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.

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 2	Drug: Atorvastatin 20 mg
EXPERIMENTAL: 3	Drug: AEGR-733 5 mg
PLACEBO_COMPARATOR: 1	Drug: Placebo
EXPERIMENTAL: 4	Drug: AEGR-733 10 mg
EXPERIMENTAL: 5	Drug: AEGR-733 5 mg + atorvastatin 20 mg
EXPERIMENTAL: 6	Drug: AEGR-733 10 mg + atorvastatin 20 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change From Baseline in LDL-C at 8 Weeks	Atfer 8 weeks on study drug

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent Change From Baseline of Other Lipids	After 8 weeks of study drug

Collaborators and Investigators

• Sponsor: Aegerion Pharmaceuticals, Inc.

Publications and helpful links

General 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. doi: 10.1056/NEJMoa061189.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (ACTUAL): October 1, 2008
• Study Completion (ACTUAL): October 1, 2008

Study Registration Dates

• First Submitted: May 14, 2007
• First Submitted That Met QC Criteria: May 14, 2007
• First Posted (ESTIMATE): May 16, 2007

Study Record Updates

• Last Update Posted (ACTUAL): March 20, 2018
• Last Update Submitted That Met QC Criteria: February 21, 2018
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: cholesterol
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: AEGR-733-003