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

NCT00729027 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1015

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 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.

Conditions

Interventions

DRUG

25 mg/day AVE5530

* one tablet in the evening with dinner * in addition to statin treatment (HMG-CoA Reductase Inhibitors)

DRUG

50 mg/day AVE5530

* one tablet in the evening with dinner * in addition to statin treatment (HMG-CoA Reductase Inhibitors)

DRUG

placebo

* one tablet in the evening with dinner * in addition to statin treatment (HMG-CoA Reductase Inhibitors)

Sponsors & Collaborators

Principal Investigators

  • Mats ERICKSSON, MD · Department of Endocrinology, Metabolism and Diabetes, Karolinska University Hospital, Huddinge, Sweden

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
2009-06-30
Completion
2009-06-30

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Israel
  • Netherlands
  • Norway
  • Poland
  • Russia
  • Spain
  • Sweden

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 NCT00729027 on ClinicalTrials.gov