Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess the safety and tolerability of E5555 in Japanese subjects with coronary artery disease.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eisai Co., Ltd.
Criteria
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.