NCT00619164

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

33 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 5, 2007

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Last Updated

May 13, 2013

Status Verified

February 1, 2010

Enrollment Period

1.8 years

First QC Date

December 5, 2007

Last Update Submit

May 9, 2013

Conditions

Acute Coronary Syndrome

Keywords

Platelet Aggregation InhibitorsCoronary StenosisCoronary Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG.

    3 months

Secondary Outcomes (1)

  • Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration.

    3 months

Study Arms (4)

1

EXPERIMENTAL
Drug: E5555

2

EXPERIMENTAL
Drug: E5555

3

EXPERIMENTAL
Drug: E5555

4

PLACEBO COMPARATOR
Drug: Placebo

Interventions

E5555DRUG

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

1
PlaceboDRUG

Placebo tablet taken orally, once a day.

4

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Unknown Facility

Toyoake, Aichi-ken, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Unknown Facility

Kasuga, Fukuoka, Japan

Location

Unknown Facility

Kitakyushu, Fukuoka, Japan

Location

Unknown Facility

Kurume, Fukuoka, Japan

Location

Unknown Facility

Gifu, Gifu, Japan

Location

Unknown Facility

Ōgaki, Gifu, Japan

Location

Unknown Facility

Fukuyama, Hiroshima, Japan

Location

Unknown Facility

Higashi-Hiroshima, Hiroshima, Japan

Location

Unknown Facility

Hiroshima, Hiroshima, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Amagasaki, Hyōgo, Japan

Location

Unknown Facility

Himaji, Hyōgo, Japan

Location

Unknown Facility

Kobe, Hyōgo, Japan

Location

Unknown Facility

Nishinomiya, Hyōgo, Japan

Location

Unknown Facility

Kagoshima, Kagoshima-ken, Japan

Location

Unknown Facility

Yokohama, Kanagawa, Japan

Location

Unknown Facility

Ōmura, Nakasaki, Japan

Location

Unknown Facility

Beppu, Oita Prefecture, Japan

Location

Unknown Facility

Urazoe, Okinawa, Japan

Location

Unknown Facility

Osaka, Osaka, Japan

Location

Unknown Facility

Wako, Saitama, Japan

Location

Unknown Facility

Komatsushimachō, Tokushima, Japan

Location

Unknown Facility

Bunkyo, Tokyo, Japan

Location

Unknown Facility

Fuchū, Tokyo, Japan

Location

Unknown Facility

Hachiōji, Tokyo, Japan

Location

Unknown Facility

Kodaira, Tokyo, Japan

Location

Unknown Facility

Nerima City, Tokyo, Japan

Location

Unknown Facility

Shinagawa-ku, Tokyo, Japan

Location

Unknown Facility

Shinagawa, Tokyo, Japan

Location

Unknown Facility

Shinjuku, Tokyo, Japan

Location

Unknown Facility

tabashi City, Tokyo, Japan

Location

Unknown Facility

Tanabe, Wakayama, Japan

Location

MeSH Terms

Conditions

Acute Coronary SyndromeCoronary StenosisCoronary Thrombosis

Interventions

E 5555

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesCoronary DiseaseThrombosisEmbolism and Thrombosis

Study Officials

  • Masaru Takeuchi

    New Product Development, Clinical Research Center, Eisai Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2007

First Posted

February 20, 2008

Study Start

November 1, 2007

Primary Completion

September 1, 2009

Last Updated

May 13, 2013

Record last verified: 2010-02

Locations

JP(33)