MedTrace Logo

Evaluation of Efficacy and Safety of AVE5530 Co-administered With Atorvastatin in Primary Hypercholesterolemia

NCT00741715 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1736

Last updated 2016-05-16

No results posted yet for this study

Summary

The present study is assessing the efficacy and safety of AVE5530 (25mg and 50mg) co-administered with all approved doses of atorvastatin in a double-blind comparison with placebo, AVE5530 alone and atorvastatin alone in the management of patients with primary hypercholesterolemia. The main objective is to evaluate the effects of the association AVE5530+atorvastatin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530+atorvastatin on other lipid parameters will be assessed as secondary objectives

Conditions

Interventions

DRUG

AVE5530

oral administration once daily in the evening with dinner

DRUG

atorvastatin

oral administration once daily in the evening with dinner

DRUG

placebo

oral administration once daily in the evening with dinner

Sponsors & Collaborators

Principal Investigators

  • Davidson Michael, MD · Radiant Research - 515 North State Street Suite 2700 Chicago Illinois (US)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-05-31
Completion
2009-06-30

Countries

  • United States
  • Puerto Rico

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 NCT00741715 on ClinicalTrials.gov