Clinical Trial: Evaluation of Efficacy and Safety of AVE5530 in Patients With Primary Hypercholesterolemia
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Double-blind, Randomized, 12-month, Placebo-controlled, Parallel Group, Fixed-dose Study to Evaluate the Efficacy and Safety of AVE5530 25mg/Day and AVE5530 50 mg/Day in Patients With Primary
Brief Summary: The present study is aiming at assessing the efficacy and safety of AVE5530 (25mg and 50mg) in a double-blind comparison with placebo in the management of patients with primary hypercholesterolemia. The main objective is to evaluate the effects of AVE5530 on LDL-C level reduction as adjunct to a controlled diet. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.
Detailed Summary: The study will include a 2-week pre-randomization placebo lead-in phase and a double-blind treatment period of at least 12 months and can be variably extended up to approximately 18 months.
Sponsor: Sanofi
Current Primary Outcome: percent change from baseline in calculated LDL-C [ Time Frame: at week 12 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- percent change from baseline in calculated LDL-C [ Time Frame: at 6 months and 12 months ]
- percent change from baseline in total cholesterol and Apo-B [ Time Frame: at 12 weeks, 6 months and 12 months ]
Original Secondary Outcome: Same as current
Information By: Sanofi
Dates:
Date Received: July 18, 2008
Date Started: July 2008
Date Completion:
Last Updated: April 15, 2016
Last Verified: April 2016
