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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619164
• Other study ID #: E5555-J081-207
• Status: Completed
• Phase: Phase 2
• First received: December 5, 2007
• Last updated: May 9, 2013
• Start date: November 2007

Study information

• Verified date: February 2010
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• E5555
E5555, 50 mg (tablet), taken orally, once a day.
• E5555
E5555, 100 mg (tablet), taken orally, once a day.
• E5555
E5555, 200 mg (tablet), taken orally, once a day.
• Placebo
Placebo tablet taken orally, once a day.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG.		3 months	Yes
Secondary	Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration.		3 months	Yes