Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing High Doses of Statins in Patients With Primary Severe Hypercholesterolemia

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

643 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-06-30

Brief Summary

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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 management of patients with severe 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.

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Detailed Description

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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 period of at least 12 months and can be variably extended up to approximately 18 months.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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