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

This study is ongoing, but not recruiting participants.

First Received: December 5, 2007 Last Updated: August 26, 2009 History of Changes

Sponsored by:	Eisai Inc.
Information provided by:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00619164

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome

Resource links provided by NLM:

Drug Information available for: E 5555

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Safety and tolerability. [ 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 ]

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

Arms	Assigned Interventions
1: Experimental	Drug: E5555 E5555 50 mg (tablet) taken orally, once a day.
2: Experimental	Drug: E5555 E5555, 100 mg (tablet) taken orally, once a day.
3: Experimental	Drug: E5555 E5555, 200 mg (tablet) taken orally, once a day.
4: Placebo Comparator	Drug: Placebo Placebo tablet taken orally, once a day.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Unwilling or unable to provide informed consent
History of acquired or congenital bleeding disorder, coagulopathy, or platelet disorder
Recent trauma or major surgery
Evidence of active pathological bleeding at screening or history of gastrointestinal or genitourinary bleeding with unknown cause within 24 weeks prior to screening
History of intracranial bleeding or history of hemorrhagic retinopathy
History of New York Heart Association (NYHA) class III or IV congestive heart failure
Pregnant or lactating women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619164

Sponsors and Collaborators

Eisai Inc.

Investigators

Study Director:

Masaru Takeuchi

New Product Development, Clinical Research Center, Eisai Co., Ltd.

More Information

No publications provided

Responsible Party:	Department New Drug Development, Clinical Research Center ( Masaru Takeuchi )
Study ID Numbers:	E5555-J081-207
Study First Received:	December 5, 2007
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00619164 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:

Platelet Aggregation Inhibitors
Coronary Stenosis
Coronary Thrombosis

Study placed in the following topic categories:

Heart Diseases
Myocardial Ischemia
Acute Coronary Syndrome
Vascular Diseases
Platelet Aggregation Inhibitors

Constriction, Pathologic
Ischemia
Coronary Thrombosis
Coronary Stenosis
Thrombosis

Additional relevant MeSH terms:

Heart Diseases
Pathologic Processes
Disease
Therapeutic Uses
Myocardial Ischemia
Syndrome

Hematologic Agents
Acute Coronary Syndrome
Vascular Diseases
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009