Ignite Creation Date:
2024-05-05 @ 9:16 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00852397
Status:
TERMINATED
Last Update Posted:
2013-08-29
First Post:
2009-02-26
Brief Title:
A Study to Evaluate the Safety of Apixaban in Acute Coronary Syndrome ACS Japanese Patients
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Phase 2 Placebo-Controlled Randomized Double-Blinded Multicenter Study To Evaluate The Bleeding Profile Of 25 Mg And 50 Mg BID Apixaban In Combination With Standard Therapy In Patients With Recent 7 Days Acute Coronary Syndrome ACS
Status:
TERMINATED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See termination reason in detailed description
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the bleeding safety the composite endpoint of major and clinically relevant non-major bleeding of 2 doses of apixaban 25 mg BID and 50 mg BID or placebo in combination with standard therapy aspirin and or additional antiplatelet therapy over a 24 week treatment period in selected subjects with recent 7 days acute coronary syndrome
Detailed Description:
Due to withdraw of global phase 3 study APPRAISE-2 for safety issue B0661004 Data monitoring committee DMC also recommended terminating this study Therefore Pfizer decided to stop this study
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