Clinical Trial: Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing Statins in Patients With Primary Hypercholesterolemia
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Multicenter, Double-blind, Randomized, 12-month, Placebo-controlled Study to Evaluate the Lipid-lowering Effect, Safety and Tolerability of AVE5530 25 mg/Day and 50mg/Day When Added to Ongoing Stabl
Brief Summary:
The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing statin treatment in a double-blind manner in comparison with placebo, in the management of patients with primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment.
The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.
Detailed Summary: 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 screening phase up to 2 weeks, 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: August 1, 2008
Date Started: July 2008
Date Completion:
Last Updated: April 15, 2016
Last Verified: April 2016
