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European Trial About Effect of RimoNabant on Abdominal Obese Patients With dysLipidemia

NCT00412698 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 645

Last updated 2010-12-10

No results posted yet for this study

Summary

Primary :

To determine the effect of Rimonabant 20 mg on changes in, HDL-Cholesterol (HDL-C), triglyceride levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with dyslipidemia with or without other associated comorbidities.

Main Secondary :

To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference (WC), body weight, glycemic and lipid parameters.

To assess the safety of 12 months Rimonabant treatment versus placebo in these patients.

In selected sites, a sub study will be conducted to determine the effect of 12 months of Rimonabant on additional lipoprotein and inflammatory parameters.

Conditions

Interventions

DRUG

rimonabant

Administration of one tablet containing 20 mg of active rimonabantonce daily in the morning. White film-coated tablets, for oral administration containing 20 mg of active rimonabant

DRUG

Placebo

Administration of one rimonabant placebo tablet once daily in the morning. Undistinguishable placebo tablets.

Sponsors & Collaborators

Principal Investigators

  • Valérie Pilorget, MD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • Czechia
  • Finland
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Netherlands
  • Norway
  • Portugal
  • Slovakia
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

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 NCT00412698 on ClinicalTrials.gov