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

May 9, 2013 updated by: Eisai Co., Ltd.
The purpose of this study is to assess the safety and tolerability of E5555 in Japanese subjects with coronary artery disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Gifu, Japan
      • Kumamoto, Japan
      • Osaka, Japan
      • Saitama, Japan
      • Shizuoka, Japan
    • Aichi
      • Ichinomiya, Aichi, Japan
    • Gifu
      • Ogaki, Gifu, Japan
    • Hokkaido
      • Asahikawa, Hokkaido, Japan
      • Chitose, Hokkaido, Japan
      • Sapporo, Hokkaido, Japan
      • Tomakomai, Hokkaido, Japan
    • Hyogo
      • Himeji, Hyogo, Japan
      • Nishinomiya, Hyogo, Japan
    • Ibaraki
      • Tsuchiura, Ibaraki, Japan
    • Ishikawa
      • Kanazawa, Ishikawa, Japan
    • Kanagawa
      • Yokohama, Kanagawa, Japan
    • Mie
      • Matsusaka, Mie, Japan
      • Tsu, Mie, Japan
    • Osaka
      • Osakasayama, Osaka, Japan
    • Saitama
      • Kitamoto, Saitama, Japan
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
      • Musashino, Tokyo, Japan
      • Ota-ku, Tokyo, Japan
      • Shinjuku-ku, Tokyo, Japan
      • Tachikawa, Tokyo, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: E5555 50 mg
E5555 50 mg (tablet) taken orally, once a day.
Experimental: 2
Drug: E5555 100 mg
E5555 100 mg (tablet) taken orally, once a day.
Experimental: 3
Drug: E5555 200 mg
E5555 200 mg (tablet) taken orally, once a day.
Placebo Comparator: 4
Drug: Placebo
Placebo (tablet) taken orally, once a day.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Co., Ltd.

Investigators

  • Study Director: Masaru Takeuchi, New Product Development, Clinical Research Center, Eisai Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

October 4, 2007

First Submitted That Met QC Criteria

October 4, 2007

First Posted (Estimate)

October 8, 2007

Study Record Updates

Last Update Posted (Estimate)

May 13, 2013

Last Update Submitted That Met QC Criteria

May 9, 2013

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E5555-J081-206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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