A Double-Blind Study of E5555 in Japanese Subjects With Coronary Artery Disease
1 other identifier
interventional
240
1 country
25
Brief Summary
The purpose of this study is to assess the safety and tolerability of E5555 in Japanese subjects with coronary artery disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 coronary-artery-disease
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 4, 2007
CompletedFirst Posted
Study publicly available on registry
October 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedMay 13, 2013
February 1, 2010
1.4 years
October 4, 2007
May 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG
6 months
Secondary Outcomes (1)
Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration.
6 months
Study Arms (4)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- years old (at time of informed consent).
- Male or female (females of childbearing potential must use contraception).
- Confirmed coronary artery disease.
- All subjects must be receiving aspirin (75 - 325 mg).
You may not qualify if:
- Unwilling or unable to provide informed consent.
- History of acquired or congenital bleeding disorder, coagulopathy, or platelet disorder.
- Recent trauma or major surgery.
- Evidence of active pathological bleeding or history of bleeding such as gastrointestinal or genitourinary, unless the cause has been definitely corrected.
- History of intracranial bleeding or history of hemorrhagic retinopathy.
- New York Heart Association class III or IV congestive heart failure.
- Pregnant or lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (25)
Unknown Facility
Ichinomiya, Aichi-ken, Japan
Unknown Facility
Gifu, Gifu, Japan
Unknown Facility
Ōgaki, Gifu, Japan
Unknown Facility
Asahikawa, Hokkaido, Japan
Unknown Facility
Chitose, Hokkaido, Japan
Unknown Facility
Sapporo, Hokkaido, Japan
Unknown Facility
Tomakomai, Hokkaido, Japan
Unknown Facility
Himeji, Hyōgo, Japan
Unknown Facility
Nishinomiya, Hyōgo, Japan
Unknown Facility
Tsuchiura, Ibaraki, Japan
Unknown Facility
Kanazawa, Ishikawa-ken, Japan
Unknown Facility
Yokohama, Kanagawa, Japan
Unknown Facility
Kumamoto, Kumamoto, Japan
Unknown Facility
Matsusaka, Mie-ken, Japan
Unknown Facility
Tsu, Mie-ken, Japan
Unknown Facility
Osaka, Osaka, Japan
Unknown Facility
Sayama, Osaka, Japan
Unknown Facility
Kitamoto, Saitama, Japan
Unknown Facility
Saitama, Saitama, Japan
Unknown Facility
Shizuoka, Shizuoka, Japan
Unknown Facility
Bunkyo-ku, Tokyo, Japan
Unknown Facility
Musashino, Tokyo, Japan
Unknown Facility
Ōta-ku, Tokyo, Japan
Unknown Facility
Shinjuku-ku, Tokyo, Japan
Unknown Facility
Tachikawa, Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Masaru Takeuchi
New Product Development, Clinical Research Center, Eisai Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2007
First Posted
October 8, 2007
Study Start
October 1, 2007
Primary Completion
March 1, 2009
Last Updated
May 13, 2013
Record last verified: 2010-02