ClinicalTrials.gov
ClinicalTrials.gov Menu

Japanese Study of Rimonabant in Obese Patients With Dyslipidemia (VENUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00434096
Recruitment Status : Terminated (Company decision taken in light of demands by certain national health authorities)
First Posted : February 12, 2007
Last Update Posted : July 20, 2009
Sponsor:
Information provided by:
Sanofi

Brief Summary:

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 or disease Intervention/treatment Phase
Obesity Drug: rimonabant (SR141716) Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 915 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Study Start Date : February 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : February 2009

Arm Intervention/treatment
Experimental: 1 Drug: rimonabant (SR141716)
oral administration once daily

Placebo Comparator: 2 Drug: placebo
oral administration once daily




Primary Outcome Measures :
  1. body weight: relative change from baseline [ Time Frame: Week 52 ]
  2. triglycerides: relative change from baseline [ Time Frame: Week 52 ]

Secondary Outcome Measures :
  1. HDL-cholesterol ;visceral fat area [ Time Frame: Week 52 ]
  2. Safety: Adverse events [ Time Frame: study period ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00434096


Locations
Japan
Sanofi-Aventis Administrative Office
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00434096     History of Changes
Other Study ID Numbers: EFC5749
First Posted: February 12, 2007    Key Record Dates
Last Update Posted: July 20, 2009
Last Verified: July 2009

Keywords provided by Sanofi:
Obesity disease
cannabinoid-1 receptor

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rimonabant
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs