Long-Term Effect of 10 mg Versus 20 mg Rimonabant in Overweight or Obese Patients

Obesity Clinical Trial

— MODERATO  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00678483
• Other study ID #: EFC10139
• Secondary ID: EudraCT : 2007-0
• Status: Terminated
• Phase: Phase 3
• First received: May 13, 2008
• Last updated: June 16, 2009
• Start date: April 2008
• Est. completion date: February 2009

Study information

• Verified date: June 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ministry of Public HealthSouth Africa: Department of HealthNetherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 331
• Est. completion date: February 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Drug:
• rimonabant (SR141716)
once daily

Locations

Country	Name	City	State
Croatia	Sanofi-Aventis Administrative Office	Zagreb
Finland	Sanofi-Aventis Administrative Office	Helsinki
Hungary	Sanofi- Aventis Administrative Office	Budapest
Netherlands	Sanofi-Aventis Administrative Office	Gouda
Romania	Sanofi-Aventis Administrative Office	Bucuresti

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Croatia,  Finland,  Hungary,  Netherlands,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the change in weight from baseline to 12 months		12 months	No
Secondary	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		12 months	No
Secondary	Safety : Vital signs, adverse events, laboratory tests		12 months	No