Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412698
Status:
TERMINATED
Last Update Posted:
2010-12-10
First Post:
2006-12-15
Brief Title:
European Trial About Effect of RimoNabant on Abdominal Obese Patients With dysLipidemia
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A European Randomized Parallel Group Two-arm Placebo-controlled Double-blind Multicenter Study of Rimonabant 20mg Once Daily in the Treatment of Abdominally Obese Patients With Dyslipidemia With or Without Other Comorbidities
Status:
TERMINATED
Status Verified Date:
2010-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company decision has been taken in light of recent demands by certain national health authorities
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETERNAL
Brief Summary:
Primary
To determine the effect of Rimonabant 20 mg on changes in HDL-Cholesterol HDL-C triglyceride levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with dyslipidemia with or without other associated comorbidities
Main Secondary
To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference WC body weight glycemic and lipid parameters
To assess the safety of 12 months Rimonabant treatment versus placebo in these patients
In selected sites a sub study will be conducted to determine the effect of 12 months of Rimonabant on additional lipoprotein and inflammatory parameters
To determine the effect of Rimonabant 20 mg on changes in HDL-Cholesterol HDL-C triglyceride levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with dyslipidemia with or without other associated comorbidities
Main Secondary
To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference WC body weight glycemic and lipid parameters
To assess the safety of 12 months Rimonabant treatment versus placebo in these patients
In selected sites a sub study will be conducted to determine the effect of 12 months of Rimonabant on additional lipoprotein and inflammatory parameters
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT 2006-001715-30 | None | None | None |