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

NCT00766688 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 643

Last updated 2016-05-16

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

AVE5530

* one tablet in the evening with dinner * in addition to high doses of statin treatment

DRUG

Placebo

* one tablet in the evening with dinner * in addition to high doses of statin treatment

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-04-30
Completion
2009-06-30

Countries

  • United States
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Israel
  • Netherlands
  • Russia
  • Slovakia
  • South Africa
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00766688 on ClinicalTrials.gov