NCT00540670CompletedPhase 2
A Double-Blind Study of E5555 in Japanese Subjects With Coronary Artery Disease
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 240
- Primary Endpoint
- Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG
Study Overview
Brief Summary
The purpose of this study is to assess the safety and tolerability of E5555 in Japanese subjects with coronary artery disease.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 45 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
Experimental
Intervention: E5555 50 mg (Drug)
2
Experimental
Intervention: E5555 100 mg (Drug)
3
Experimental
Intervention: E5555 200 mg (Drug)
4
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG
Time Frame: 6 months
Secondary Outcomes
- Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration.(6 months)
Investigators
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