- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00619164
A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome
May 9, 2013 updated by: Eisai Co., Ltd.
The purpose of this study is to assess the safety and tolerability of E5555 in Japanese patients with acute coronary syndrome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
240
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fukuoka, Japan
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Gifu, Japan
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Hiroshima, Japan
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Kagoshima, Japan
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Osaka, Japan
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Aichi
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Toyoake, Aichi, Japan
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Fukuoka
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Kasuga, Fukuoka, Japan
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Kitakyusyu, Fukuoka, Japan
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Kurume, Fukuoka, Japan
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Gifu
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Ogaki, Gifu, Japan
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Hiroshima
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Fukuyama, Hiroshima, Japan
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Higashi-Hiroshima, Hiroshima, Japan
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Hokkaido
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Sapporo, Hokkaido, Japan
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Hyogo
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Amagasaki, Hyogo, Japan
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Himaji, Hyogo, Japan
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Kobe, Hyogo, Japan
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Nishinomiya, Hyogo, Japan
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Kanagawa
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Yokohama, Kanagawa, Japan
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Nakasaki
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Omura, Nakasaki, Japan
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Oita
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Beppu, Oita, Japan
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Okinawa
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Urazoe, Okinawa, Japan
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Saitama
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Wako, Saitama, Japan
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Tokushima
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Komatsushima, Tokushima, Japan
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Tokyo
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Bunkyo, Tokyo, Japan
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Fuchu, Tokyo, Japan
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Hachioji, Tokyo, Japan
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Itabashi, Tokyo, Japan
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Kodaira, Tokyo, Japan
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Nerima, Tokyo, Japan
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Shinagawa, Tokyo, Japan
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Shinagawa-ku, Tokyo, Japan
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Shinjuku, Tokyo, Japan
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Wakayama
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Tanabe, Wakayama, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 45 - 80 years old (at time of informed consent)
- Male or female (females of childbearing potential must be contracepted)
- Confirmed acute coronary syndrome
Exclusion Criteria:
- 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 at screening or history of gastrointestinal or genitourinary bleeding with unknown cause within 24 weeks prior to screening
- History of intracranial bleeding or history of hemorrhagic retinopathy
- History of New York Heart Association (NYHA) class III or IV congestive heart failure
- Pregnant or lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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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.
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Experimental: 2
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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.
|
Experimental: 3
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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
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Placebo tablet taken orally, once a day.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG.
Time Frame: 3 months
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3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration.
Time Frame: 3 months
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Masaru Takeuchi, New Product Development, Clinical Research Center, Eisai Co., Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
December 5, 2007
First Submitted That Met QC Criteria
February 8, 2008
First Posted (Estimate)
February 20, 2008
Study Record Updates
Last Update Posted (Estimate)
May 13, 2013
Last Update Submitted That Met QC Criteria
May 9, 2013
Last Verified
February 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E5555-J081-207
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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