A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome

Eisai

Status and phase: Completed; Phase 2

Conditions: Acute Coronary Syndrome

Treatments: Drug: Placebo; Drug: E5555

Study type: Interventional

Funder types: Industry

Identifiers

NCT00619164

E5555-J081-207

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of E5555 in Japanese patients with acute coronary syndrome.

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 be contracepted)
3. Confirmed acute coronary syndrome

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 at screening or history of gastrointestinal or genitourinary bleeding with unknown cause within 24 weeks prior to screening
5. History of intracranial bleeding or history of hemorrhagic retinopathy
6. History of New York Heart Association (NYHA) 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

Drug: E5555

Drug: E5555

2

Experimental group

Treatment:

Drug: E5555

Drug: E5555

Drug: E5555

3

Experimental group

Treatment:

Drug: E5555

Drug: E5555

Drug: E5555

4

Placebo Comparator group

Treatment:

Drug: Placebo