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Completed

NCT Number: NCT00540670

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

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ichinomiya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 45 - 80 years old (at time of informed consent).
  • Male or female (females of childbearing potential must use contraception).
  • Confirmed coronary artery disease.
  • All subjects must be receiving aspirin (75 - 325 mg).

Exclusion criteria

  • 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 or history of bleeding such as gastrointestinal or genitourinary, unless the cause has been definitely corrected.
  • History of intracranial bleeding or history of hemorrhagic retinopathy.
  • New York Heart Association class III or IV congestive heart failure.
  • Pregnant or lactating women.

Treatment and study plan

E5555 50 mg

Drug

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

E5555 100 mg

Drug

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

E5555 200 mg

Drug

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

Placebo

Drug

Placebo (tablet) taken orally, once a day.

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Important dates

Study start
2007
Primary completion
2009
First posted
Oct 8, 2007
Registry last updated
May 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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