Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Aegerion Pharmaceuticals, Inc. |
---|---|
Information provided by: | Aegerion Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00474240 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
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 |
---|---|
1: Placebo Comparator | Drug: Placebo |
2: Active Comparator | Drug: Atorvastatin 20 mg |
3: Experimental | Drug: AEGR-733 5 mg |
4: Experimental | Drug: AEGR-733 10 mg |
5: Experimental | Drug: AEGR-733 5 mg + atorvastatin 20 mg |
6: Experimental | Drug: AEGR-733 10 mg + atorvastatin 20 mg |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | Aegerion Pharmaceuticals ( William J Sasiela PhD Chief Medical Officer ) |
Study ID Numbers: | 733-003 |
Study First Received: | May 14, 2007 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00474240 History of Changes |
Health Authority: | United States: Food and Drug Administration |
cholesterol |
Antimetabolites Metabolic Diseases Hyperlipidemias Antilipemic Agents Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Metabolic Disorder Hypercholesterolemia Atorvastatin Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Enzyme Inhibitors Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Therapeutic Uses Hypercholesterolemia Dyslipidemias Atorvastatin Lipid Metabolism Disorders |