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

Sponsor

Eisai Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT00619164

Collaborator

(none)

240

Enrollment

Locations

Arms

7.3

Patients Per Site

Study Details

Study Description

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: E5555 Drug: E5555 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

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 :

Nov 1, 2007

Actual Primary Completion Date :

Sep 1, 2009

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG. [3 months]

Secondary Outcome Measures

Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration. [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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

Locations

	City	State	Country
1	Toyoake	Aichi	Japan
2	Kasuga	Fukuoka	Japan
3	Kitakyusyu	Fukuoka	Japan
4	Kurume	Fukuoka	Japan
5	Ogaki	Gifu	Japan
6	Fukuyama	Hiroshima	Japan
7	Higashi-Hiroshima	Hiroshima	Japan
8	Sapporo	Hokkaido	Japan
9	Amagasaki	Hyogo	Japan
10	Himaji	Hyogo	Japan
11	Kobe	Hyogo	Japan
12	Nishinomiya	Hyogo	Japan
13	Yokohama	Kanagawa	Japan
14	Omura	Nakasaki	Japan
15	Beppu	Oita	Japan
16	Urazoe	Okinawa	Japan
17	Wako	Saitama	Japan
18	Komatsushima	Tokushima	Japan
19	Bunkyo	Tokyo	Japan
20	Fuchu	Tokyo	Japan
21	Hachioji	Tokyo	Japan
22	Itabashi	Tokyo	Japan
23	Kodaira	Tokyo	Japan
24	Nerima	Tokyo	Japan
25	Shinagawa-ku	Tokyo	Japan
26	Shinagawa	Tokyo	Japan
27	Shinjuku	Tokyo	Japan
28	Tanabe	Wakayama	Japan
29	Fukuoka		Japan
30	Gifu		Japan
31	Hiroshima		Japan
32	Kagoshima		Japan
33	Osaka		Japan