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A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome

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ClinicalTrials.gov Identifier: NCT00619164
Recruitment Status : Completed
First Posted : February 20, 2008
Last Update Posted : May 13, 2013
Sponsor:
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 patients with acute coronary syndrome.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: E5555 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 Patients With Acute Coronary Syndrome
Study Start Date : November 2007
Primary Completion Date : September 2009

Arm Intervention/treatment
Experimental: 1 Drug: E5555
E5555, 50 mg (tablet), taken orally, once a day.
Experimental: 2 Drug: E5555
E5555, 100 mg (tablet), taken orally, once a day.
Experimental: 3 Drug: E5555
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: 3 months ]

Secondary Outcome Measures :
  1. Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration. [ Time Frame: 3 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
Criteria

Inclusion Criteria:

  1. 45 - 80 years old (at time of informed consent)
  2. Male or female (females of childbearing potential must be contracepted)
  3. Confirmed acute coronary syndrome

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 at screening or history of gastrointestinal or genitourinary bleeding with unknown cause within 24 weeks prior to screening
  5. History of intracranial bleeding or history of hemorrhagic retinopathy
  6. History of New York Heart Association (NYHA) 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 ClinicalTrials.gov identifier (NCT number): NCT00619164


Locations
Japan
Toyoake, Aichi, Japan
Kasuga, Fukuoka, Japan
Kitakyusyu, Fukuoka, Japan
Kurume, Fukuoka, Japan
Ogaki, Gifu, Japan
Fukuyama, Hiroshima, Japan
Higashi-Hiroshima, Hiroshima, Japan
Sapporo, Hokkaido, Japan
Amagasaki, Hyogo, Japan
Himaji, Hyogo, Japan
Kobe, Hyogo, Japan
Nishinomiya, Hyogo, Japan
Yokohama, Kanagawa, Japan
Omura, Nakasaki, Japan
Beppu, Oita, Japan
Urazoe, Okinawa, Japan
Wako, Saitama, Japan
Komatsushima, Tokushima, Japan
Bunkyo, Tokyo, Japan
Fuchu, Tokyo, Japan
Hachioji, Tokyo, Japan
Itabashi, Tokyo, Japan
Kodaira, Tokyo, Japan
Nerima, Tokyo, Japan
Shinagawa-ku, Tokyo, Japan
Shinagawa, Tokyo, Japan
Shinjuku, Tokyo, Japan
Tanabe, Wakayama, Japan
Fukuoka, Japan
Gifu, Japan
Hiroshima, Japan
Kagoshima, Japan
Osaka, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Masaru Takeuchi New Product Development, Clinical Research Center, Eisai Co., Ltd.

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT00619164     History of Changes
Other Study ID Numbers: E5555-J081-207
First Posted: February 20, 2008    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: February 2010

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Platelet Aggregation Inhibitors
Coronary Stenosis
Coronary Thrombosis

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Platelet Aggregation Inhibitors