Back to resultsA Double-Blind Study of E5555 in Japanese Subjects With Coronary Artery Disease
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
E5555 50 mg
E5555 100 mg
E5555 200 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease
Eligibility Criteria
Inclusion Criteria:
- 45 - 80 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).
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 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
Outcomes
Primary Outcome Measures
Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG
Secondary Outcome Measures
Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00540670
Brief Title
A Double-Blind Study of E5555 in Japanese Subjects With Coronary Artery Disease
Official Title
A Double-Blind Study of E5555 in Japanese Subjects With Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and tolerability of E5555 in Japanese subjects with coronary artery disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
E5555 50 mg
Intervention Description
E5555 50 mg (tablet) taken orally, once a day.
Intervention Type
Drug
Intervention Name(s)
E5555 100 mg
Intervention Description
E5555 100 mg (tablet) taken orally, once a day.
Intervention Type
Drug
Intervention Name(s)
E5555 200 mg
Intervention Description
E5555 200 mg (tablet) taken orally, once a day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (tablet) taken orally, once a day.
Primary Outcome Measure Information:
Title
Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
45 - 80 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).
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masaru Takeuchi
Organizational Affiliation
New Product Development, Clinical Research Center, Eisai Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Ichinomiya
State/Province
Aichi
Country
Japan
City
Ogaki
State/Province
Gifu
Country
Japan
City
Asahikawa
State/Province
Hokkaido
Country
Japan
City
Chitose
State/Province
Hokkaido
Country
Japan
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Tomakomai
State/Province
Hokkaido
Country
Japan
City
Himeji
State/Province
Hyogo
Country
Japan
City
Nishinomiya
State/Province
Hyogo
Country
Japan
City
Tsuchiura
State/Province
Ibaraki
Country
Japan
City
Kanazawa
State/Province
Ishikawa
Country
Japan
City
Yokohama
State/Province
Kanagawa
Country
Japan
City
Matsusaka
State/Province
Mie
Country
Japan
City
Tsu
State/Province
Mie
Country
Japan
City
Osakasayama
State/Province
Osaka
Country
Japan
City
Kitamoto
State/Province
Saitama
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
City
Musashino
State/Province
Tokyo
Country
Japan
City
Ota-ku
State/Province
Tokyo
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
City
Tachikawa
State/Province
Tokyo
Country
Japan
City
Gifu
Country
Japan
City
Kumamoto
Country
Japan
City
Osaka
Country
Japan
City
Saitama
Country
Japan
City
Shizuoka
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Double-Blind Study of E5555 in Japanese Subjects With Coronary Artery Disease
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