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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474240
• Other study ID #: AEGR-733-003
• Status: Completed
• Phase: Phase 2
• First received: May 14, 2007
• Last updated: February 21, 2018
• Start date: April 2007
• Est. completion date: October 2008

Study information

• Verified date: January 2013
• Source: Aegerion Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Atorvastatin 20 mg

• AEGR-733 5 mg

• AEGR-733 10 mg

• Placebo

• AEGR-733 5 mg + atorvastatin 20 mg

• AEGR-733 10 mg + atorvastatin 20 mg

Locations

Country	Name	City	State
United States	Maine Research Associates	Auburn	Maine
United States	Health Trends Research	Baltimore	Maryland
United States	Radiant Research	Chicago	Illinois
United States	Sterling Research Group	Cincinnati	Ohio
United States	Dallas Diabetes and Endocrine Center	Dallas	Texas
United States	Diabetes and Glandular Disease Research	Dallas	Texas
United States	Medsphere Medical Research Center	Evansville	Indiana
United States	Coastal Carolina Research Center	Goose Creek	South Carolina
United States	Medical Affiliated Research Center	Huntsville	Alabama
United States	Midwest Institute for Clinical Research	Indianapolis	Indiana
United States	Jacksonville Center for Clinical research	Jacksonville	Florida
United States	Jacksonville Center For Clinical Research	Jacksonville	Florida
United States	Hampton Roads Center for Clinical Research	Norfolk	Virginia
United States	Renstar Medical Research	Ocala	Florida
United States	National Clinical Research	Richmond	Virginia
United States	Piedmont Medical Research Associates	Winston-Salem	North Carolina
United States	North Georgia Clinical Research	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Aegerion Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in LDL-C at 8 Weeks		Atfer 8 weeks on study drug
Secondary	Percent Change From Baseline of Other Lipids		After 8 weeks of study drug