AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia
This study has been completed.
Sponsor:
Aegerion Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00474240
First received: May 14, 2007
Last updated: January 18, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Aegerion Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Percent Change From Baseline in LDL-C at 8 Weeks [ Time Frame: Atfer 8 weeks on study drug ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percent Change From Baseline of Other Lipids [ Time Frame: After 8 weeks of study drug ] [ Designated as safety issue: No ]
| Enrollment: | 157 |
| Study Start Date: | April 2007 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 | Drug: Placebo |
| Active Comparator: 2 | Drug: Atorvastatin 20 mg |
| Experimental: 3 | Drug: AEGR-733 5 mg |
| 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 |
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00474240
Locations
| United States, Alabama | |
| Medical Affiliated Research Center | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Florida | |
| Jacksonville Center For Clinical Research | |
| Jacksonville, Florida, United States, 32216 | |
| Jacksonville Center for Clinical research | |
| Jacksonville, Florida, United States, 32205 | |
| Renstar Medical Research | |
| Ocala, Florida, United States, 34471 | |
| United States, Georgia | |
| North Georgia Clinical Research | |
| Woodstock, Georgia, United States, 30189 | |
| United States, Illinois | |
| Radiant Research | |
| Chicago, Illinois, United States, 60610 | |
| United States, Indiana | |
| Medsphere Medical Research Center | |
| Evansville, Indiana, United States, 47714 | |
| Midwest Institute for Clinical Research | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Maine | |
| Maine Research Associates | |
| Auburn, Maine, United States, 04210 | |
| United States, Maryland | |
| Health Trends Research | |
| Baltimore, Maryland, United States, 21209 | |
| United States, North Carolina | |
| Piedmont Medical Research Associates | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Sterling Research Group | |
| Cincinnati, Ohio, United States, 45246 | |
| United States, South Carolina | |
| Coastal Carolina Research Center | |
| Goose Creek, South Carolina, United States, 29445 | |
| United States, Texas | |
| Dallas Diabetes and Endocrine Center | |
| Dallas, Texas, United States, 75230 | |
| Diabetes and Glandular Disease Research | |
| Dallas, Texas, United States, 78229 | |
| United States, Virginia | |
| Hampton Roads Center for Clinical Research | |
| Norfolk, Virginia, United States, 23502 | |
| National Clinical Research | |
| Richmond, Virginia, United States, 23294 | |
Sponsors and Collaborators
Aegerion Pharmaceuticals, Inc.
More Information
Publications:
| Responsible Party: | Aegerion Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00474240 History of Changes |
| Other Study ID Numbers: | 733-003 |
| Study First Received: | May 14, 2007 |
| Results First Received: | January 18, 2013 |
| Last Updated: | January 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Aegerion Pharmaceuticals, Inc.:
|
cholesterol |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013