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Evaluation of Efficacy and Safety of AVE5530 in Patients With Primary Hypercholesterolemia

NCT00718965 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 826

Last updated 2016-05-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

AVE5530

one tablet in the evening with dinner

DRUG

Placebo

one tablet in the evening with dinner

Sponsors & Collaborators

Principal Investigators

  • John CROUSE, MD · Wake Forest University Health Sciences, North Carolina, US

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-11-30
Completion
2009-06-30

Countries

  • United States
  • Puerto Rico

Study Locations

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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 NCT00718965 on ClinicalTrials.gov