Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00458081
Status:
TERMINATED
Last Update Posted:
2010-12-10
First Post:
2007-04-06
Brief Title:
Evaluation of the Rimonabant Impact on the Regression of Asymptomatic Damage Caused by Cardiovascular Risk Factors
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A 12-month Multicentre Randomised Double-blind Placebo-controlled Study With Two Parallel Groups to Assess the Effects of Rimonabant 20 mg in Patients With Abdominal Obesity and Microalbuminuria With Type 2 Diabetes Mellitus or Dyslipidaemia With or Without Other Cardiometabolic Risk Factors
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:
RIALTO
Brief Summary:
Primary objective
To assess the effect on microalbuminuria levels of treatment with rimonabant 20 mg versus a placebo during a 12 month period
Secondary objectives
Percentage of patients in both arms of the study whose levels of microalbuminuria decrease stabilise increase towards macroalbuminuria or are unchanged after 12 months of treatment with rimonabant or placebo
To assess the effect of treatment with rimonabant 20 mg versus placebo over a 12 month period on
Weight and waist circumference
Glycaemia profile fasting glycaemia fasting insulinaemia and HbA1c
Lipid and lipoprotein profile triglycerides total cholesterol HDL-C LDL-C apolipoproteins A1 and B
Inflammatory markers
Adipocytokines
Blood pressure
Glomerular filtration rate
To assess the quality of life by means of questionnaire filled in
Safety parameters
To assess the effect on microalbuminuria levels of treatment with rimonabant 20 mg versus a placebo during a 12 month period
Secondary objectives
Percentage of patients in both arms of the study whose levels of microalbuminuria decrease stabilise increase towards macroalbuminuria or are unchanged after 12 months of treatment with rimonabant or placebo
To assess the effect of treatment with rimonabant 20 mg versus placebo over a 12 month period on
Weight and waist circumference
Glycaemia profile fasting glycaemia fasting insulinaemia and HbA1c
Lipid and lipoprotein profile triglycerides total cholesterol HDL-C LDL-C apolipoproteins A1 and B
Inflammatory markers
Adipocytokines
Blood pressure
Glomerular filtration rate
To assess the quality of life by means of questionnaire filled in
Safety 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 2006-002951-33 | None | None | None |