Japanese Study of Rimonabant in Obese Patients With Dyslipidemia (VENUS) - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00434096

Purpose

The primary objective of this study is to assess the efficacy of SR141716 compared to placebo on body weight and triglycerides changes over a period of 52 weeks.

Secondary objectives are:

To evaluate the effect of SR141716 compared to placebo over a period of 52 weeks, on HDL-cholesterol and visceral fat area.
To evaluate the safety of SR141716 compared to placebo over a period of 104 weeks.
To evaluate the pharmacokinetics of SR141716.

Condition	Intervention	Phase
Obesity	Drug: rimonabant (SR141716) Drug: placebo	Phase III

MedlinePlus related topics: Cholesterol Obesity

Drug Information available for: SR 141716A Rimonabant

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Double-Blind, Placebo-Controlled, Parallel-Group, Fixed Single-Dose Regimen (SR141716 20 mg), Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Patients With Dyslipidemia.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

body weight: relative change from baseline [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
triglycerides: relative change from baseline [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HDL-cholesterol ;visceral fat area [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Safety: Adverse events [ Time Frame: study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	816
Study Start Date:	February 2007
Study Completion Date:	February 2009
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: rimonabant (SR141716) oral administration once daily
2: Placebo Comparator	Drug: placebo oral administration once daily

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Body Mass Index (BMI) > 25 kg/m²
Visceral Fat Area (VFA) > 100 cm²
Triglycerides (TG) > 150 mg/dL and < 700 mg/dL, and/or HDL-cholesterol < 40 mg/dL(Dyslipidemia)
At least 1 criteria of the following 2 comorbidities:
- Impaired Glucose Tolerance or Type 2 diabetes
- Hypertension

Exclusion Criteria:

Patient with a secondary obesity.
Patients who have received the diet therapy for less than 8 weeks before start of the observation period.
Patients whose body weight changed by more than the variation of ± 2kg for screening period.
Low compliance to drug intake (< 80%) and dietary instruction during the observation period.
Patients with type 1 diabetes.
Patients with a primary hyperlipidemia (i.e., familial hypercholesterolemia, familial combined hyperlipidemia and familial type III hyperlipidemia).
Patients with a LDL-cholesterol > 190 mg/dL at any of Weeks -8 or -4.
Patients with a secondary hypertension.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434096

Locations

Japan
Sanofi-Aventis Administrative Office
Tokyo, Japan

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC5749
Study First Received:	February 9, 2007
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00434096 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi-Aventis:

Obesity disease
cannabinoid-1 receptor

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Metabolic Diseases
Nutrition Disorders

Overweight
Overnutrition
Metabolic Disorder
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Metabolic Diseases
Nutrition Disorders

Overweight
Overnutrition
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009