Status:
TERMINATED
Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing High Doses of Statins in Patients With Primary Severe Hypercholesterolemia
Lead Sponsor:
Sanofi
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing treatment with high doses of statin in a double-blind manner in comparison with placebo, in the...
Detailed Description
The two doses of AVE5530 tested in this study are 25 mg and 50 mg taken in the evening, with dinner dosing. The study will include a pre-randomization phase up to 6 weeks, a double-blind treatment per...
Eligibility Criteria
Inclusion
- Adults with severe primary hypercholesterolemia and cholesterol levels not controlled on ongoing stable statin treatment at maximum doses.
Exclusion
- LDL-C levels \> 250 mg/dL (6.48 mmol/L) or \< 100 mg/dL (2.59 mmol/L)
- Triglycerides \>350 mg/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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
643 Patients enrolled
Trial Details
Trial ID
NCT00766688
Start Date
October 1 2008
End Date
June 1 2009
Last Update
May 16 2016
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales, Australia
3
Sanofi-Aventis Administrative Office
Diegem, Belgium
4
Sanofi-Aventis Administrative Office
Sofia, Bulgaria