Back to resultsA Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
E5555
E5555
E5555
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Platelet Aggregation Inhibitors, Coronary Stenosis, Coronary Thrombosis
Eligibility Criteria
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
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
NCT00619164
Brief Title
A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome
Official Title
A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 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 patients with acute coronary syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Platelet Aggregation Inhibitors, Coronary Stenosis, Coronary Thrombosis
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
Intervention Description
E5555, 50 mg (tablet), taken orally, once a day.
Intervention Type
Drug
Intervention Name(s)
E5555
Intervention Description
E5555, 100 mg (tablet), taken orally, once a day.
Intervention Type
Drug
Intervention Name(s)
E5555
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
3 months
Secondary Outcome Measure Information:
Title
Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration.
Time Frame
3 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 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
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
Toyoake
State/Province
Aichi
Country
Japan
City
Kasuga
State/Province
Fukuoka
Country
Japan
City
Kitakyusyu
State/Province
Fukuoka
Country
Japan
City
Kurume
State/Province
Fukuoka
Country
Japan
City
Ogaki
State/Province
Gifu
Country
Japan
City
Fukuyama
State/Province
Hiroshima
Country
Japan
City
Higashi-Hiroshima
State/Province
Hiroshima
Country
Japan
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Amagasaki
State/Province
Hyogo
Country
Japan
City
Himaji
State/Province
Hyogo
Country
Japan
City
Kobe
State/Province
Hyogo
Country
Japan
City
Nishinomiya
State/Province
Hyogo
Country
Japan
City
Yokohama
State/Province
Kanagawa
Country
Japan
City
Omura
State/Province
Nakasaki
Country
Japan
City
Beppu
State/Province
Oita
Country
Japan
City
Urazoe
State/Province
Okinawa
Country
Japan
City
Wako
State/Province
Saitama
Country
Japan
City
Komatsushima
State/Province
Tokushima
Country
Japan
City
Bunkyo
State/Province
Tokyo
Country
Japan
City
Fuchu
State/Province
Tokyo
Country
Japan
City
Hachioji
State/Province
Tokyo
Country
Japan
City
Itabashi
State/Province
Tokyo
Country
Japan
City
Kodaira
State/Province
Tokyo
Country
Japan
City
Nerima
State/Province
Tokyo
Country
Japan
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
City
Shinagawa
State/Province
Tokyo
Country
Japan
City
Shinjuku
State/Province
Tokyo
Country
Japan
City
Tanabe
State/Province
Wakayama
Country
Japan
City
Fukuoka
Country
Japan
City
Gifu
Country
Japan
City
Hiroshima
Country
Japan
City
Kagoshima
Country
Japan
City
Osaka
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome
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