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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00678483

Purpose

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.

Condition	Intervention	Phase
Obesity Weight Loss	Drug: rimonabant (SR141716)	Phase III

MedlinePlus related topics: Cholesterol Obesity Weight Control

Drug Information available for: Insulin Dextrose Cholest-5-en-3-ol (3beta)- Rimonabant SR 141716A

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

The primary endpoint is the change in weight from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Safety : Vital signs, adverse events, laboratory tests [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	522
Study Start Date:	April 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 10 mg	Drug: rimonabant (SR141716) once daily
2: Experimental 20 mg	Drug: rimonabant (SR141716) once daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678483

Locations

Croatia
Sanofi-Aventis Administrative Office
Zagreb, Croatia
Finland
Sanofi-Aventis Administrative Office
Helsinki, Finland
Hungary
Sanofi- Aventis Administrative Office
Budapest, Hungary
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Romania
Sanofi-Aventis Administrative Office
Bucuresti, Romania

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD )
Study ID Numbers:	EFC10139, EudraCT : 2007-002492-14
Study First Received:	May 13, 2008
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00678483
Health Authority:	Romania: Ministry of Public Health; South Africa: Department of Health; Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Sanofi-Aventis:

Cholesterol
HDL
triglycerides
insulin
blood glucose

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss
Body Weight Changes

Nutrition Disorders
Overnutrition
Overweight
Insulin

ClinicalTrials.gov processed this record on January 15, 2009