Ignite Creation Date:
2024-05-06 @ 12:42 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01636271
Status:
COMPLETED
Last Update Posted:
2014-11-02
First Post:
2012-05-31
Brief Title:
SB-480848 in Major Adverse Cardiovascular Events - Integrated Summary of Efficacy and Safety From the STABILITY Trial LPL100601 and the SOLID-TIMI-52 Trial SB-480848033
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
SB-480848 in Major Adverse Cardiovascular Events - Integrated Phase III Summary of Efficacy and Safety
Status:
COMPLETED
Status Verified Date:
2014-10
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:
None
Brief Summary:
The overall objective of this integrated analysis is to evaluate the clinical safety and efficacy of long-term treatment with darapladib enteric coated tablets 160mg as compared to placebo when added to standard of care in subjects with clinical manifestations of cardiovascular disease chronic coronary heart disease CHD and post Acute Coronary Syndrome ACS With respect to efficacy the key purpose of this integrated analysis is to evaluate the effects of darapladib on the following endpoints urgent coronary revascularization for myoacrdial ischemia fatalnon-fatal stroke time to subsequent Major Adverse Cardiovascular Event MACE and heart failure requiring hospitalization The first occurrent of MACE Major and total coronary events as well as the individual components of MACE will also be evaluated descriptively
Detailed Description:
The objective of the integrated safety analysis is to characterize the safety profile of darapladib in subjects with clinical manifestations of cardiovascular disease chronic coronary heart disease CHD and post Acute Coronary Syndrome ACS
The purpose of the integrated efficacy analysis is to test the effects of darapladib on select endpoints which are not part of the testing hierarchies associated with the individual studies namely urgent coronary revascularization for myocardial ischemia stroke subsequent MACE and heart failure requiring hospitalization For all other endpoints the intent of the integrated analysis is to provide increased precision of the estimated effects of darapladib
The purpose of the integrated efficacy analysis is to test the effects of darapladib on select endpoints which are not part of the testing hierarchies associated with the individual studies namely urgent coronary revascularization for myocardial ischemia stroke subsequent MACE and heart failure requiring hospitalization For all other endpoints the intent of the integrated analysis is to provide increased precision of the estimated effects of darapladib
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