Status:

COMPLETED

Japanese Dose-Response Study of Rimonabant in Obese Patients

Lead Sponsor:

Sanofi

Conditions:

Obesity

Eligibility:

All Genders

20-70 years

Phase:

PHASE2

Brief Summary

The primary objective is to verify the dose-response relationship of rimonabant on body weight change. The secondary objectives are to compare the effect of 3 doses of SR141716 to placebo, on body we...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Body Mass Index ≥25 kg/m²
  • Viceral Fat Area ≥ 100 cm²
  • Diet therapy for more than 8 weeks before start of the placebo observation period
  • Stable weight (variation \< ±3kg within 8 weeks before start of observation period)
  • At least 2 criteria of the following 3 comorbidities: Impaired Glucose Tolerance or Type 2 diabetes, Dyslipidemia (hypertriglyceridemia and/or low HDL-choresterol), Hypertension

Exclusion

    Key Trial Info

    Start Date :

    October 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2006

    Estimated Enrollment :

    527 Patients enrolled

    Trial Details

    Trial ID

    NCT00459004

    Start Date

    October 1 2004

    End Date

    April 1 2006

    Last Update

    April 7 2009

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Sanofi-Aventis

    Tokyo, Japan