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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT00619164
First received: December 5, 2007
Last updated: May 9, 2013
Last verified: February 2010
  Purpose

The purpose of this study is to assess the safety and tolerability of E5555 in Japanese patients with acute coronary syndrome.


Condition Intervention Phase
Acute Coronary Syndrome
Drug: E5555
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 Patients With Acute Coronary Syndrome

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: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, Tokyo, Japan
Shinagawa-ku, 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.
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT00619164     History of Changes
Other Study ID Numbers: E5555-J081-207
Study First Received: December 5, 2007
Last Updated: May 9, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Platelet Aggregation Inhibitors
Coronary Stenosis
Coronary Thrombosis

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Platelet Aggregation Inhibitors
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014