Status:

COMPLETED

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

Lead Sponsor:

Eisai Co., Ltd.

Conditions:

Acute Coronary Syndrome

Eligibility:

All Genders

45-80 years

Phase:

PHASE2

Brief Summary

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

Eligibility Criteria

Inclusion

  • 45 - 80 years old (at time of informed consent)
  • Male or female (females of childbearing potential must be contracepted)
  • Confirmed acute coronary syndrome

Exclusion

  • Unwilling or unable to provide informed consent
  • History of acquired or congenital bleeding disorder, coagulopathy, or platelet disorder
  • Recent trauma or major surgery
  • Evidence of active pathological bleeding at screening or history of gastrointestinal or genitourinary bleeding with unknown cause within 24 weeks prior to screening
  • History of intracranial bleeding or history of hemorrhagic retinopathy
  • History of New York Heart Association (NYHA) class III or IV congestive heart failure
  • Pregnant or lactating women

Key Trial Info

Start Date :

November 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

240 Patients enrolled

Trial Details

Trial ID

NCT00619164

Start Date

November 1 2007

Last Update

May 13 2013

Active Locations (33)

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Page 1 of 9 (33 locations)

1

Toyoake, Aichi-ken, Japan

2

Fukuoka, Fukuoka, Japan

3

Kasuga, Fukuoka, Japan

4

Kitakyushu, Fukuoka, Japan

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