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

Phase 2

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: E5555 100 mg; Drug: E5555 50 mg; Drug: E5555 200 mg; Drug: Placebo

• Registration Number: NCT00540670
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-04
• Study First Submitted QC: 2007-10-04
• Study First Posted: 2007-10-08
• Primary Completion: 2009-03
• Status Verified: 2010-02
• Last Update Submitted: 2013-05-09
• Last Update Posted: 2013-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	E5555 100 mg	-
1	E5555 50 mg	-
3	E5555 200 mg	-
4	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG	6 months

Secondary Outcome Measures

Name	Time	Method
Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration.	6 months