Acute Coronary SyndromePhase 2NCT00619164
A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome
A Phase 2 study testing E5555 in people with Acute Coronary Syndrome, run by Eisai Co., Ltd. at 33 sites in Japan.
Trial summary
The purpose of this study is to assess the safety and tolerability of E5555 in Japanese patients with acute coronary syndrome. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- E5555
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 33 sitesJapan
- Study dates
- Nov 2007to Sep 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45 - 80 years old (at time of informed consent)
- Male or female (females of childbearing potential must be contracepted)
- Confirmed acute coronary syndrome
Who cannot join
- 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
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Japan33 sites
Study site
Amagasaki, Hyōgo
Study site
Beppu, Oita Prefecture
Study site
Bunkyo, Tokyo
Study site
Fuchū, Tokyo
Study site
Fukuoka, Fukuoka
Study site
Fukuyama, Hiroshima
Study site
Gifu, Gifu
Study site
Hachiōji, Tokyo
Study site
Higashi-Hiroshima, Hiroshima
Study site
Himaji, Hyōgo
Study site
Hiroshima, Hiroshima
Study site
Kagoshima, Kagoshima-ken
Study site
Kasuga, Fukuoka
Study site
Kitakyushu, Fukuoka
Study site
Kobe, Hyōgo
Study site
Kodaira, Tokyo
Study site
Komatsushimachō, Tokushima
Study site
Kurume, Fukuoka
Study site
Nerima City, Tokyo
Study site
Nishinomiya, Hyōgo
Study site
Ōgaki, Gifu
Study site
Ōmura, Nakasaki
Study site
Osaka, Osaka
Study site
Sapporo, Hokkaido
Study site
Shinagawa, Tokyo
Study site
Shinagawa-ku, Tokyo
Study site
Shinjuku, Tokyo
Study site
tabashi City, Tokyo
Study site
Tanabe, Wakayama
Study site
Toyoake, Aichi-ken
Study site
Urazoe, Okinawa
Study site
Wako, Saitama
Study site
Yokohama, Kanagawa
About this study
The purpose of this study is to assess the safety and tolerability of E5555 in Japanese patients with acute coronary syndrome.
- Conditions
- Acute Coronary Syndrome
- Being tested
- E5555, Placebo
- Keywords
- Platelet Aggregation Inhibitors, Coronary Stenosis, Coronary Thrombosis
- Medical subject headings
- Acute Coronary Syndrome, Coronary Stenosis, Coronary Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E5555Drug
E5555, 50 mg (tablet), taken orally, once a day.
E5555Drug
E5555, 100 mg (tablet), taken orally, once a day.
E5555Drug
E5555, 200 mg (tablet), taken orally, once a day.
PlaceboDrug
Placebo tablet taken orally, once a day.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: E5555 |
| 2 | Experimental | Not described Receives: Drug: E5555 |
| 3 | Experimental | Not described Receives: Drug: E5555 |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG.
Measured: 3 months
Secondary outcomes (1)
Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Masaru Takeuchi, Study director, New Product Development, Clinical Research Center, Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619164
- Sponsor's protocol ID
- E5555-J081-207
- Status last verified
- Feb 2010
- First submitted
- 5 Dec 2007
- Last updated
- 13 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT00619164
- Acronym / sponsor ID
- E5555-J081-207
- Conditions
- Acute Coronary Syndrome
- Keywords
- Platelet Aggregation Inhibitors, Coronary Stenosis, Coronary Thrombosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Sep 2009 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of E5555 in Japanese patients with acute coronary syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: E5555 |
| 2 | Experimental | Drug: E5555 |
| 3 | Experimental | Drug: E5555 |
| 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 45 - 80 years old (at time of informed consent)
- Male or female (females of childbearing potential must be contracepted)
- Confirmed acute coronary syndrome
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E5555E5555, 50 mg (tablet), taken orally, once a day. | Drug | 1 |
| E5555E5555, 100 mg (tablet), taken orally, once a day. | Drug | 2 |
| E5555E5555, 200 mg (tablet), taken orally, once a day. | Drug | 3 |
| PlaceboPlacebo tablet taken orally, once a day. | Drug | 4 |
Primary outcome
Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG.
Time frame: 3 months
1 secondary outcome
Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masaru Takeuchi study director
New Product Development, Clinical Research Center, Eisai Co., Ltd.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing E5555 in people with Acute Coronary Syndrome, run by Eisai Co., Ltd. at 33 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2013.