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Rimonabant in Abdominally Obese Patients With Impaired Fasting Blood Glucose

NCT00405808 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2666

Last updated 2011-01-26

No results posted yet for this study

Summary

Primary objective:

To determine the effect of Rimonabant 20mg on the co-primary endpoint including Fasting Plasma Glucose (FPG), HDL-Cholesterol (HDL-C) and triglyceride (TG) levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with impaired fasting blood glucose and with or without associated comorbidities.

Main Secondary objectives:

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

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

Conditions

Interventions

DRUG

Rimonabant

Once daily in the morning

DRUG

Placebo

Once daily in the morning

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
2009-02-28
Completion
2009-02-28

Countries

  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Czechia
  • Denmark
  • Egypt
  • Finland
  • France
  • Greece
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Lithuania
  • Luxembourg
  • Mexico
  • Netherlands
  • Norway
  • Portugal
  • Slovakia
  • Spain
  • 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 NCT00405808 on ClinicalTrials.gov