AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia
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
1 other identifier
interventional
157
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2007
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 14, 2007
CompletedFirst Posted
Study publicly available on registry
May 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
February 21, 2013
CompletedMarch 20, 2018
January 1, 2013
1.5 years
May 14, 2007
January 18, 2013
February 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in LDL-C at 8 Weeks
Atfer 8 weeks on study drug
Secondary Outcomes (1)
Percent Change From Baseline of Other Lipids
After 8 weeks of study drug
Study Arms (6)
1
PLACEBO COMPARATOR2
ACTIVE COMPARATOR3
EXPERIMENTAL4
EXPERIMENTAL5
EXPERIMENTAL6
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Medical Affiliated Research Center
Huntsville, Alabama, 35801, United States
Jacksonville Center for Clinical research
Jacksonville, Florida, 32205, United States
Jacksonville Center For Clinical Research
Jacksonville, Florida, 32216, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
Radiant Research
Chicago, Illinois, 60610, United States
Medsphere Medical Research Center
Evansville, Indiana, 47714, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260, United States
Maine Research Associates
Auburn, Maine, 04210, United States
Health Trends Research
Baltimore, Maryland, 21209, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103, United States
Sterling Research Group
Cincinnati, Ohio, 45246, United States
Coastal Carolina Research Center
Goose Creek, South Carolina, 29445, United States
Dallas Diabetes and Endocrine Center
Dallas, Texas, 75230, United States
Diabetes and Glandular Disease Research
Dallas, Texas, 78229, United States
Hampton Roads Center for Clinical Research
Norfolk, Virginia, 23502, United States
National Clinical Research
Richmond, Virginia, 23294, United States
Related 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. doi: 10.1056/NEJMoa061189.
PMID: 17215532BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study AEGR-733-003, initiated in May 2007, was halted, and restarted under an amended Protocol in November 2007.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Aegerion Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2007
First Posted
May 16, 2007
Study Start
April 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
March 20, 2018
Results First Posted
February 21, 2013
Record last verified: 2013-01