Status:
TERMINATED
Long-Term Effect of 10 mg Versus 20 mg Rimonabant in Overweight or Obese Patients
Lead Sponsor:
Sanofi
Conditions:
Obesity
Weight Loss
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to assess, over a period of 12 months, the effect on weight loss and weight maintenance of rimonabant 10 mg in comparison with rimonabant 20 mg in overweight/obe...
Eligibility Criteria
Inclusion
- Body Mass index (BMI) of at least 30 kg/m² or BMI \>27 kg/m² with associated risk factors such as type 2 diabetes or dyslipidemia
Exclusion
- Weight loss \> 5 kg within 3 months prior to screening Visit.
- Presence of any clinically significant endocrine disease including the presence of type 1 diabetes
- Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders
- Previous participation in a clinical study with rimonabant
- Administration of other investigational drugs, anti-obesity drugs or other drugs for weight reduction
- Pregnancy and absence of effective contraceptive method for females of childbearing potential
- Exenatide
- Insulin therapy
- Recent change or need for change in the oral antidiabetic treatment
- Recent change or need for change in the lipid lowering treatment
- Presence of severe renal or hepatic impairment
- The above information is not intented to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT00678483
Start Date
April 1 2008
End Date
February 1 2009
Last Update
June 17 2009
Active Locations (5)
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1
Sanofi-Aventis Administrative Office
Zagreb, Croatia
2
Sanofi-Aventis Administrative Office
Helsinki, Finland
3
Sanofi- Aventis Administrative Office
Budapest, Hungary
4
Sanofi-Aventis Administrative Office
Gouda, Netherlands