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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00540670

Enrollment

240

Registered

2007-10-08

Start date

2007-10-31

Completion date

Unknown

Last updated

2013-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease

Brief summary

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

Interventions

DRUGE5555 50 mg

E5555 50 mg (tablet) taken orally, once a day.

DRUGE5555 100 mg

E5555 100 mg (tablet) taken orally, once a day.

DRUGE5555 200 mg

E5555 200 mg (tablet) taken orally, once a day.

DRUGPlacebo

Placebo (tablet) taken orally, once a day.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

45 Years to 80 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration.	6 months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026