A Double-Blind Study of E5555 in Japanese Subjects With Coronary Artery Disease
NCT ID: NCT00540670
Last Updated: 2013-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
240 participants
INTERVENTIONAL
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
E5555 50 mg
E5555 50 mg (tablet) taken orally, once a day.
2
E5555 100 mg
E5555 100 mg (tablet) taken orally, once a day.
3
E5555 200 mg
E5555 200 mg (tablet) taken orally, once a day.
4
Placebo
Placebo (tablet) taken orally, once a day.
Interventions
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E5555 50 mg
E5555 50 mg (tablet) taken orally, once a day.
E5555 100 mg
E5555 100 mg (tablet) taken orally, once a day.
E5555 200 mg
E5555 200 mg (tablet) taken orally, once a day.
Placebo
Placebo (tablet) taken orally, once a day.
Eligibility Criteria
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Inclusion Criteria
2. Male or female (females of childbearing potential must use contraception).
3. Confirmed coronary artery disease.
4. All subjects must be receiving aspirin (75 - 325 mg).
Exclusion Criteria
2. History of acquired or congenital bleeding disorder, coagulopathy, or platelet disorder.
3. Recent trauma or major surgery.
4. Evidence of active pathological bleeding or history of bleeding such as gastrointestinal or genitourinary, unless the cause has been definitely corrected.
5. History of intracranial bleeding or history of hemorrhagic retinopathy.
6. New York Heart Association class III or IV congestive heart failure.
7. Pregnant or lactating women.
45 Years
80 Years
ALL
No
Sponsors
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Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Masaru Takeuchi
Role: STUDY_DIRECTOR
New Product Development, Clinical Research Center, Eisai Co., Ltd.
Locations
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Ichinomiya, Aichi-ken, Japan
Gifu, Gifu, Japan
Ōgaki, Gifu, Japan
Asahikawa, Hokkaido, Japan
Chitose, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Tomakomai, Hokkaido, Japan
Himeji, Hyōgo, Japan
Nishinomiya, Hyōgo, Japan
Tsuchiura, Ibaraki, Japan
Kanazawa, Ishikawa-ken, Japan
Yokohama, Kanagawa, Japan
Kumamoto, Kumamoto, Japan
Matsusaka, Mie-ken, Japan
Tsu, Mie-ken, Japan
Osaka, Osaka, Japan
Sayama, Osaka, Japan
Kitamoto, Saitama, Japan
Saitama, Saitama, Japan
Shizuoka, Shizuoka, Japan
Bunkyo-ku, Tokyo, Japan
Musashino, Tokyo, Japan
Ōta-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Tachikawa, Tokyo, Japan
Countries
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Other Identifiers
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E5555-J081-206
Identifier Type: -
Identifier Source: org_study_id
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