Clinical Trial: A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome
Brief Summary: The purpose of this study is to assess the safety and tolerability of E5555 in Japanese patients with acute coronary syndrome.
Detailed Summary:
Sponsor: Eisai Co., Ltd.
Current Primary Outcome: Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG. [ Time Frame: 3 months ]
Original Primary Outcome: To determine the safety and tolerability of E5555 in comparison with a placebo. [ Time Frame: 16 weeks ]
Current Secondary Outcome: Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration. [ Time Frame: 3 months ]
Original Secondary Outcome: Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration [ Time Frame: 16 weeks ]
Information By: Eisai Inc.
Dates:
Date Received: December 5, 2007
Date Started: November 2007
Date Completion:
Last Updated: May 9, 2013
Last Verified: February 2010