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Long-Term Effect of 10 mg Versus 20 mg Rimonabant in Overweight or Obese Patients

NCT00678483 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 331

Last updated 2009-06-17

No results posted yet for this study

Summary

The primary objective of this study is to assess, over a period of 12 months, the effect on weight loss and weight maintenance of rimonabant 10 mg in comparison with rimonabant 20 mg in overweight/obese patients after an initial treatment period of 6 months with rimonabant 20 mg.

Secondary objectives are to assess the effect of rimonabant over a period of 12 months on waist circumference, high-density lipoprotein (HDL)-Cholesterol and triglycerides (TG), fasting plasma glucose (FPG), fasting insulin and to evaluate the long-term safety and tolerability of rimonabant 10 mg and 20 mg over a period of 12 months after randomization in overweight/obese patients.

Conditions

Interventions

DRUG

rimonabant (SR141716)

once daily

Sponsors & Collaborators

Principal Investigators

  • ICD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-11-30
Completion
2009-02-28

Countries

  • Croatia
  • Finland
  • Hungary
  • Netherlands
  • Romania

Study Locations

More Related Trials

Entities

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 NCT00678483 on ClinicalTrials.gov