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Japanese Dose-Response Study of Rimonabant in Obese Patients

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ClinicalTrials.gov Identifier: NCT00459004
Recruitment Status : Completed
First Posted : April 11, 2007
Last Update Posted : April 7, 2009
Sponsor:
Information provided by:
Sanofi

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 weight loss and on secondary criteria associated with comorbidities, and to evaluate the safety and the pharmacokinetics of SR141716.


Condition or disease Intervention/treatment Phase
Obesity Drug: rimonabant (SR141716) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 527 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Dose-Response Relationship Study of SR141716 in Obese Patients
Study Start Date : October 2004
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources




Primary Outcome Measures :
  1. absolute change in body weight from baseline to Week 24

Secondary Outcome Measures :
  1. Efficacy: body weight, visceral fat area, waist circumference, fasting plasma glucose, HbA1c, triglyceride, HDL-cholesterol, blood pressure
  2. Safety:adverse events, laboratory tests, ECGs
  3. Pharmacokinetics: SR141716 plasma trough concentrations


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00459004


Locations
Japan
Sanofi-Aventis
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Kohji SHIRAI, Professor Toho University Sakura Medical Center, Japan

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00459004     History of Changes
Other Study ID Numbers: DRI5747
First Posted: April 11, 2007    Key Record Dates
Last Update Posted: April 7, 2009
Last Verified: April 2009

Keywords provided by Sanofi:
weight loss

Additional relevant MeSH terms:
Rimonabant
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs