Trial | NCT00459004  Report issue

Title

Japanese Dose-Response Study of Rimonabant in Obese Patients
A Dose-Response Relationship Study of SR141716 in Obese Patients

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    rimonabant ...

  • Study Participants

    527
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 weight loss and on secondary criteria associated with comorbidities, and to evaluate the safety and the pharmacokinetics of SR141716.
Study Started
Oct 31
2004
Primary Completion
Apr 30
2006
Study Completion
Apr 30
2006
Last Update
Apr 07
2009
Estimate

Drug rimonabant (SR141716)

Criteria 

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
No Results Posted