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

December 5, 2007
May 9, 2013
November 2007
September 2009   (final data collection date for primary outcome measure)
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 ]
To determine the safety and tolerability of E5555 in comparison with a placebo. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00619164 on ClinicalTrials.gov Archive Site
Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome
A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Acute Coronary Syndrome
  • Drug: E5555
    E5555, 50 mg (tablet), taken orally, once a day.
  • Drug: E5555
    E5555, 100 mg (tablet), taken orally, once a day.
  • Drug: E5555
    E5555, 200 mg (tablet), taken orally, once a day.
  • Drug: Placebo
    Placebo tablet taken orally, once a day.
  • Experimental: 1
    Intervention: Drug: E5555
  • Experimental: 2
    Intervention: Drug: E5555
  • Experimental: 3
    Intervention: Drug: E5555
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
Not Provided
September 2009   (final data collection date for primary outcome measure)

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
Both
45 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00619164
E5555-J081-207
Not Provided
Eisai Inc. ( Eisai Co., Ltd. )
Eisai Co., Ltd.
Not Provided
Study Director: Masaru Takeuchi New Product Development, Clinical Research Center, Eisai Co., Ltd.
Eisai Inc.
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP