Study Stopped
Company decision taken in light of demands by certain national health authorities
Japanese Study of Rimonabant in Obese Patients With Dyslipidemia (VENUS)
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.
1 other identifier
interventional
915
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started Feb 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 9, 2007
CompletedFirst Posted
Study publicly available on registry
February 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedJuly 20, 2009
July 1, 2009
1.8 years
February 9, 2007
July 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
body weight: relative change from baseline
Week 52
triglycerides: relative change from baseline
Week 52
Secondary Outcomes (2)
HDL-cholesterol ;visceral fat area
Week 52
Safety: Adverse events
study period
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis Administrative Office
Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ICD CSD
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 9, 2007
First Posted
February 12, 2007
Study Start
February 1, 2007
Primary Completion
November 1, 2008
Study Completion
February 1, 2009
Last Updated
July 20, 2009
Record last verified: 2009-07