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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00540670
Recruitment Status : Completed
First Posted : October 8, 2007
Last Update Posted : May 13, 2013
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: E5555 50 mg Drug: E5555 100 mg Drug: E5555 200 mg Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind Study of E5555 in Japanese Subjects With Coronary Artery Disease
Study Start Date : October 2007
Actual Primary Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00540670

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

Responsible Party: Eisai Co., Ltd. Identifier: NCT00540670     History of Changes
Other Study ID Numbers: E5555-J081-206
First Posted: October 8, 2007    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: February 2010

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Coronary artery disease

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