A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome
This study has been completed.
Eisai Co., Ltd.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
First received: December 5, 2007
Last updated: May 9, 2013
Last verified: February 2010
The purpose of this study is to assess the safety and tolerability of E5555 in Japanese patients with acute coronary syndrome.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome|
Further study details as provided by Eisai Inc.:
Primary Outcome Measures:
- Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2007|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
E5555, 50 mg (tablet), taken orally, once a day.
E5555, 100 mg (tablet), taken orally, once a day.
E5555, 200 mg (tablet), taken orally, once a day.
|Placebo Comparator: 4||
Placebo tablet taken orally, once a day.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619164
|Toyoake, Aichi, Japan|
|Kasuga, Fukuoka, Japan|
|Kitakyusyu, Fukuoka, Japan|
|Kurume, Fukuoka, Japan|
|Ogaki, Gifu, Japan|
|Fukuyama, Hiroshima, Japan|
|Higashi-Hiroshima, Hiroshima, Japan|
|Sapporo, Hokkaido, Japan|
|Amagasaki, Hyogo, Japan|
|Himaji, Hyogo, Japan|
|Kobe, Hyogo, Japan|
|Nishinomiya, Hyogo, Japan|
|Yokohama, Kanagawa, Japan|
|Omura, Nakasaki, Japan|
|Beppu, Oita, Japan|
|Urazoe, Okinawa, Japan|
|Wako, Saitama, Japan|
|Komatsushima, Tokushima, Japan|
|Bunkyo, Tokyo, Japan|
|Fuchu, Tokyo, Japan|
|Hachioji, Tokyo, Japan|
|Itabashi, Tokyo, Japan|
|Kodaira, Tokyo, Japan|
|Nerima, Tokyo, Japan|
|Shinagawa, Tokyo, Japan|
|Shinagawa-ku, Tokyo, Japan|
|Shinjuku, Tokyo, Japan|
|Tanabe, Wakayama, Japan|
Sponsors and Collaborators
Eisai Co., Ltd.
|Study Director:||Masaru Takeuchi||New Product Development, Clinical Research Center, Eisai Co., Ltd.|