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Japanese Study of Rimonabant in Obese Patients With Dyslipidemia (VENUS)

NCT00434096 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 915

Last updated 2009-07-20

No results posted yet for this study

Summary

The primary objective of this study is to assess the efficacy of SR141716 compared to placebo on body weight and triglycerides changes over a period of 52 weeks.

Secondary objectives are:

* To evaluate the effect of SR141716 compared to placebo over a period of 52 weeks, on HDL-cholesterol and visceral fat area.
* To evaluate the safety of SR141716 compared to placebo over a period of 104 weeks.
* To evaluate the pharmacokinetics of SR141716.

Conditions

Interventions

DRUG

rimonabant (SR141716)

oral administration once daily

DRUG

placebo

oral administration once daily

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-11-30
Completion
2009-02-28

Countries

  • Japan

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 NCT00434096 on ClinicalTrials.gov