A Double-Blind Study of E5555 in Japanese Subjects With Coronary Artery Disease

Eisai

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Disease

Treatments: Drug: E5555 50 mg; Drug: E5555 200 mg; Drug: E5555 100 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00540670

E5555-J081-206

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of E5555 in Japanese subjects with coronary artery disease.

Enrollment: 240 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 45 - 80 years old (at time of informed consent).
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

1. Unwilling or unable to provide informed consent.
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: E5555 50 mg

2

Experimental group

Treatment:

Drug: E5555 100 mg

3

Experimental group

Treatment:

Drug: E5555 200 mg

4

Placebo Comparator group

Treatment:

Drug: Placebo