A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome
NCT ID: NCT00619164
Last Updated: 2013-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
240 participants
INTERVENTIONAL
2007-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Double-Blind Study of E5555 in Japanese Subjects With Coronary Artery Disease
NCT00540670
Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease
NCT00312052
Treatment of Coronary Atherosclerosis by Insulin Sensitizers in Insulin-Resistant Patients
NCT00155350
Efficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Coronary Artery Disease
NCT00185042
Study of ONO-1101 in Patients Scheduled for Coronary Angiography
NCT00560209
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
E5555
E5555, 50 mg (tablet), taken orally, once a day.
2
E5555
E5555, 100 mg (tablet), taken orally, once a day.
3
E5555
E5555, 200 mg (tablet), taken orally, once a day.
4
Placebo
Placebo tablet taken orally, once a day.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Male or female (females of childbearing potential must be contracepted)
3. Confirmed acute coronary syndrome
Exclusion Criteria
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
45 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eisai Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Masaru Takeuchi
Role: STUDY_DIRECTOR
New Product Development, Clinical Research Center, Eisai Co., Ltd.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Toyoake, Aichi-ken, Japan
Fukuoka, Fukuoka, Japan
Kasuga, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Kurume, Fukuoka, Japan
Gifu, Gifu, Japan
Ōgaki, Gifu, Japan
Fukuyama, Hiroshima, Japan
Higashi-Hiroshima, Hiroshima, Japan
Hiroshima, Hiroshima, Japan
Sapporo, Hokkaido, Japan
Amagasaki, Hyōgo, Japan
Himaji, Hyōgo, Japan
Kobe, Hyōgo, Japan
Nishinomiya, Hyōgo, Japan
Kagoshima, Kagoshima-ken, Japan
Yokohama, Kanagawa, Japan
Ōmura, Nakasaki, Japan
Beppu, Oita Prefecture, Japan
Urazoe, Okinawa, Japan
Osaka, Osaka, Japan
Wako, Saitama, Japan
Komatsushimachō, Tokushima, Japan
Bunkyo, Tokyo, Japan
Fuchū, Tokyo, Japan
Hachiōji, Tokyo, Japan
Kodaira, Tokyo, Japan
Nerima City, Tokyo, Japan
Shinagawa-ku, Tokyo, Japan
Shinagawa, Tokyo, Japan
Shinjuku, Tokyo, Japan
tabashi City, Tokyo, Japan
Tanabe, Wakayama, Japan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
E5555-J081-207
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.