AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia
Information source: Aegerion Pharmaceuticals, Inc.
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: 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 (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Aegerion Pharmaceuticals, Inc. Overall contact:
Christy Seaholm, Phone: 608-310-4076, Email: christy.seaholm@covance.com
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percent change from baseline in LDL cholesterol at 8 weeks
Secondary outcome: Percent change from baseline of other lipids
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Christy Seaholm, Phone: 608-310-4076, Email: christy.seaholm@covance.com
Medical Affiliated Research Center, Huntsville, Alabama 35801, United States; Recruiting
Stacey Guerin, Phone: 256-533-6603, Email: sguerin@marc-research.com
Timothy Howard, MD, Principal Investigator
Jacksonville Center For Clinical Research, Jacksonville, Florida 32216, United States; Recruiting
Eva White, Phone: 904-730-0166, Email: ewhite@encoredocs.com
Karen McCrea, Phone: 904-732-6658, Email: kmccrea@encoredocs.com
Michael Koren, MD, Principal Investigator
Jacksonville Center for Clinical research, Jacksonville, Florida 32205, United States; Recruiting
Eva White, Phone: 904-730-0166, Email: ewhite@encoredocs.com
Nalini Jones, Phone: 904-693-1490, Email: njones@encoredocs.com
Jackson Downey, MD, Principal Investigator
Renstar Medical Research, Ocala, Florida 34471, United States; Recruiting
Angella Anderson, Phone: 353-629-5800, Email: angella.anderson@renstar.net
John Nardandrea, MD, Principal Investigator
North Georgia Clinical Research, Woodstock, Georgia 30189, United States; Recruiting
Dana Rahn, Phone: 678-494-0153, Email: danarahn_ngcr@msn.com
Bram Weiskopf, MD, Principal Investigator
Radiant Research, Chicago, Illinois 60610, United States; Recruiting
Antoinette Valez, Phone: 312-494-2256, Email: AntoinetteValez@RadiantResearch.com
Heather Sullivan, Phone: 312-494-2292, Email: HeatherSullivan@RadiantResearch.com
Jeffrey Geohas, MD, Principal Investigator
Medsphere Medical Research Center, Evansville, Indiana 47714, United States; Recruiting
Goergettea Lewis, Phone: 812-471-4110, Email: glewis@medsphereresearch.com
Michael Ennis, Phone: 812-471-4110, Email: mennis@medsphereresearch.com
Steven Elliott, MD, Principal Investigator
Midwest Institute for Clinical Research, Indianapolis, Indiana 46260, United States; Recruiting
Cathy Zink, Phone: 317-705-7050, Email: czink1@sbcglobal.net
Brandy Carpenter, Email: carpenterb1@sbcglobal.net
Phillip Toth, MD, Principal Investigator
Maine Research Associates, Auburn, Maine 04210, United States; Recruiting
Jessica Gamache, Phone: 207-782-9835, Ext: 148, Email: Gamachej@midmaine.com
Diane Orino, Phone: 207-782-9835, Ext: 156, Email: orinod@midmaine.com
Robert Weiss, MD, Principal Investigator
Health Trends Research, Baltimore, Maryland 21209, United States; Recruiting
Dinah Christopher, Phone: 410-484-9400, Ext: 109, Email: dchristopher@healthtrendsresearch.com
Boris Kerzner, MD, Principal Investigator
Piedmont Medical Research Associates, Winston-Salem, North Carolina 27103, United States; Recruiting
Allison Kelly, Phone: 336-714-2641, Email: akelly@piedmontmedical.com
Megan Fox, Phone: 336-714-2619, Email: mfox@piedmontmedical.com
Thomas Littlejohn III, MD, Principal Investigator
Sterling Research Group, Cincinnati, Ohio 45246, United States; Recruiting
Cathy Haynie, Phone: 513-521-5112, Email: chaynie@sterlingresearch.org
Shellie Doyle, Phone: 513-671-8080, Email: sdoyle@sterlingresearch.org
Eli Roth, MD, Principal Investigator
Coastal Carolina Research Center, Goose Creek, South Carolina 29445, United States; Recruiting
Nathan Morton, Phone: 843-856-3784, Email: nmorton@coastalcarolinaresearch.com
Mary Ellen Scesney, Phone: 843-284-2188, Email: mscesney@coastalcarolinaresearch.com
Cynthia Strout, MD, Principal Investigator
Dallas Diabetes and Endocrine Center, Dallas, Texas 75230, United States; Recruiting
Shannan Calhoun, Phone: 972-566-5002, Email: researchrecruitment@dallasdiabetes.com
Lisa Mize, Phone: 973-566-2376, Email: crc3@dallasdiabetes.com
Julio Rosenstock, MD, Principal Investigator
Diabetes and Glandular Disease Research, Dallas, Texas 78229, United States; Recruiting
Silver Bluedragon, Phone: 210-615-5565, Ext: 1315, Email: sbluedragon@dgdresearch.com
Betty Mansfield, Phone: 210-615-5565, Ext: 1460, Email: bmansfield@dgdresearch.com
Sherwyn Schwartz, MD, Principal Investigator
Hampton Roads Center for Clinical Research, Norfolk, Virginia 23502, United States; Recruiting
Barbara Miller, Phone: 757-461-2891, Email: bmiller@hrccr.net
Jennifer Watson, Phone: 757-461-2891, Ext: 208, Email: jwatson@hrccr.net
Barry Lubin, MD, Principal Investigator
National Clinical Research, Richmond, Virginia 23294, United States; Recruiting
Sue Brown, Phone: 804-672-2133, Ext: 11, Email: sbrown@ncrinc.net
Jamila Finney, Phone: 804-672-2133, Ext: 37, Email: jfinney@ncrinc.net
James McKenney, MD, Principal Investigator
Additional Information
Related 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.
Starting date: April 2007
Ending date: January 2008
Last updated: November 8, 2007
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