Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434096
Status:
TERMINATED
Last Update Posted:
2009-07-20
First Post:
2007-02-09
Brief Title:
Japanese Study of Rimonabant in Obese Patients With Dyslipidemia VENUS
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company decision taken in light of demands by certain national health authorities
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None