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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br> <br> |
| Active Comparator: 2<br> | Drug: Atorvastatin 20 mg<br> <br> |
| Experimental: 3<br> | Drug: AEGR-733 5 mg<br> <br> |
| Experimental: 4<br> | Drug: AEGR-733 10 mg<br> <br> |
| Experimental: 5<br> | Drug: AEGR-733 5 mg + atorvastatin 20 mg<br> <br> |
| Experimental: 6<br> | Drug: AEGR-733 10 mg + atorvastatin 20 mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholesterol