Clinical trial NCT00678483: Long-Term Effect of 10 mg Versus 20 mg Rimonabant in Overweight or Obese Patients
Official title: A Randomized, Double-Blind, Parallel-Group, Multicenter, Multinational Study to Assess the Long-Term Effect, Over 1 Year, of Rimonabant 10 mg in Comparison With Rimonabant 20 mg After an Initial Treatment Period of 6 Months With Rimonabant 20 mg in Overweight or Obese Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Obesity
Weight Loss
Keywords: Cholesterol
HDL
triglycerides
insulin
blood glucose
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-05-15
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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/obese patients after an initial treatment period of 6 months with rimonabant 20 mg.

Secondary objectives are to assess the effect of rimonabant over a period of 12 months on waist circumference, high-density lipoprotein (HDL)-Cholesterol and triglycerides (TG), fasting plasma glucose (FPG), fasting insulin and to evaluate the long-term safety and tolerability of rimonabant 10 mg and 20 mg over a period of 12 months after randomization in overweight/obese patients.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: The primary endpoint is the change in weight from baseline to 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Efficacy: - Absolute change in waist circumference from baseline - Relative change in HDL-Cholesterol and in Triglycerides from baseline - Absolute change in Fasting Plasma Glucose from baseline
timeFrame: 12 months
measure: Safety : Vital signs, adverse events, laboratory tests
timeFrame: 12 months
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Sanofi-Aventis Administrative Office
city: Helsinki
country: Finland
facility: Sanofi-Aventis Administrative Office
city: Budapest
country: Hungary
facility: Sanofi- Aventis Administrative Office
city: Gouda
country: Netherlands
facility: Sanofi-Aventis Administrative Office
city: Bucuresti
country: Romania
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD
role: STUDY_DIRECTOR
References: