Ignite Creation Date:
2024-05-05 @ 10:37 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01147250
Status:
COMPLETED
Last Update Posted:
2016-12-20
First Post:
2010-06-17
Brief Title:
Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 Lixisenatide
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Parallel-group Multicenter Study to Evaluate Cardiovascular Outcomes During Treatment With Lixisenatide in Type 2 Diabetic Patients After an Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELIXA
Brief Summary:
Primary Objective
- To demonstrate that lixisenatide can reduce cardiovascular CV morbidity and mortality composite endpoint of CV death non-fatal myocardial infarction MI non-fatal stroke hospitalization for unstable angina compared to placebo in type 2 diabetic participants who recently experienced an acute coronary syndrome ACS event
Secondary Objectives
To demonstrate that when compared to placebo lixisenatide can reduce
composite endpoint of CV death non-fatal MI non-fatal stroke hospitalization for unstable angina or hospitalization for heart failure
composite endpoint of CV death non-fatal MI non-fatal stroke hospitalization for unstable angina hospitalization for heart failure or coronary revascularization procedure
urinary albumin excretion based on the urinary albumincreatinine ratio
To assess the safety and tolerability of lixisenatide
- To demonstrate that lixisenatide can reduce cardiovascular CV morbidity and mortality composite endpoint of CV death non-fatal myocardial infarction MI non-fatal stroke hospitalization for unstable angina compared to placebo in type 2 diabetic participants who recently experienced an acute coronary syndrome ACS event
Secondary Objectives
To demonstrate that when compared to placebo lixisenatide can reduce
composite endpoint of CV death non-fatal MI non-fatal stroke hospitalization for unstable angina or hospitalization for heart failure
composite endpoint of CV death non-fatal MI non-fatal stroke hospitalization for unstable angina hospitalization for heart failure or coronary revascularization procedure
urinary albumin excretion based on the urinary albumincreatinine ratio
To assess the safety and tolerability of lixisenatide
Detailed Description:
The estimated maximum study duration for the first randomized participant was approximately 204 weeks 14 days with a median follow-up over all participants of approximately 91 weeks broken down as follows
placebo-run-in period 7 days 3 days
double-blind study treatment period 203 weeks 14 days with about a 37 months of recruitment period
post-treatment follow-up period 3 days 1 day
All participants were followed from randomization until the end of study which should occur when the last randomized participant had been followed for approximately 10 months The actual end date of the study was event driven and the study end when there were approximately 844 positively-adjudicated primary cardiovascular outcome events
placebo-run-in period 7 days 3 days
double-blind study treatment period 203 weeks 14 days with about a 37 months of recruitment period
post-treatment follow-up period 3 days 1 day
All participants were followed from randomization until the end of study which should occur when the last randomized participant had been followed for approximately 10 months The actual end date of the study was event driven and the study end when there were approximately 844 positively-adjudicated primary cardiovascular outcome events
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 |
|---|---|---|---|
| U1111-1116-5558 | OTHER | UTN | None |
| 2009-012852-26 | EUDRACT_NUMBER | None | None |