Japanese Dose-Response Study of Rimonabant in Obese Patients
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00459004
First received: April 10, 2007
Last updated: April 6, 2009
Last verified: April 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: rimonabant (SR141716) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Dose-Response Relationship Study of SR141716 in Obese Patients |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- absolute change in body weight from baseline to Week 24
Secondary Outcome Measures:
- Efficacy: body weight, visceral fat area, waist circumference, fasting plasma glucose, HbA1c, triglyceride, HDL-cholesterol, blood pressure
- Safety:adverse events, laboratory tests, ECGs
- Pharmacokinetics: SR141716 plasma trough concentrations
| Enrollment: | 527 |
| Study Start Date: | October 2004 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459004
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459004
Locations
| Japan | |
| Sanofi-Aventis | |
| Tokyo, Japan | |
Sponsors and Collaborators
Sanofi
Investigators
| Principal Investigator: | Kohji SHIRAI, Professor | Toho University Sakura Medical Center, Japan |
More Information
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00459004 History of Changes |
| Other Study ID Numbers: | DRI5747 |
| Study First Received: | April 10, 2007 |
| Last Updated: | April 6, 2009 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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 |
ClinicalTrials.gov processed this record on September 29, 2016