Evaluation of Efficacy and Safety of AVE5530 in Patients With Primary Hypercholesterolemia
NCT ID: NCT00718965
Last Updated: 2016-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
826 participants
INTERVENTIONAL
2008-07-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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25 mg/day AVE5530
AVE5530
one tablet in the evening with dinner
50 mg/day AVE5530
AVE5530
one tablet in the evening with dinner
Placebo
Placebo
one tablet in the evening with dinner
Interventions
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AVE5530
one tablet in the evening with dinner
Placebo
one tablet in the evening with dinner
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Triglycerides levels \> 350mg/dL (3.95 mmol/L)
* Conditions / situations such as:
* presence of any clinically significant uncontrolled endocrine disease known to influence lipids levels
* Active liver disease
* High estimated risk of Coronary Heart Disease
* Recent history of congestive heart failure , of unstable angina pectoris, myocardial infarction, coronary bypass surgery or angioplasty, or Unstable or severe peripheral artery disease
* Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody or Known to be Human Immunodeficient Virus (HIV) positive
* Pregnant or breast-feeding women,
* Women of childbearing potential not protected by effective contraceptive method of birth control (including oral contraceptives) and/or who are unwilling or unable to be tested for pregnancy prior to exposure to the Investigational Product.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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John CROUSE, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences, North Carolina, US
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
San Juan, , Puerto Rico
Countries
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Other Identifiers
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EFC6909
Identifier Type: -
Identifier Source: org_study_id
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