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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT00540670
First received: October 4, 2007
Last updated: May 9, 2013
Last verified: February 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
 Drug: E5555 50 mg
Drug: E5555 100 mg
Drug: E5555 200 mg
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind Study of E5555 in Japanese Subjects With Coronary Artery Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 240
Study Start Date: October 2007
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540670

Locations
Japan
Ichinomiya, Aichi, Japan
Ogaki, Gifu, Japan
Asahikawa, Hokkaido, Japan
Chitose, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Tomakomai, Hokkaido, Japan
Himeji, Hyogo, Japan
Nishinomiya, Hyogo, Japan
Tsuchiura, Ibaraki, Japan
Kanazawa, Ishikawa, Japan
Yokohama, Kanagawa, Japan
Matsusaka, Mie, Japan
Tsu, Mie, Japan
Osakasayama, Osaka, Japan
Kitamoto, Saitama, Japan
Bunkyo-ku, Tokyo, Japan
Musashino, Tokyo, Japan
Ota-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Tachikawa, Tokyo, Japan
Gifu, Japan
Kumamoto, Japan
Osaka, Japan
Saitama, Japan
Shizuoka, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Masaru Takeuchi New Product Development, Clinical Research Center, Eisai Co., Ltd.
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT00540670     History of Changes
Other Study ID Numbers: E5555-J081-206
Study First Received: October 4, 2007
Last Updated: May 9, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013