Coronary Artery DiseasePhase 2NCT00540670
A Double-Blind Study of E5555 in Japanese Subjects With Coronary Artery Disease
A Phase 2 study testing E5555 50 mg, E5555 100 mg and E5555 200 mg in people with Coronary Artery Disease, run by Eisai Co., Ltd. at 25 sites in Japan.
Trial summary
The purpose of this study is to assess the safety and tolerability of E5555 in Japanese subjects with coronary artery disease. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- E5555 50 mg, E5555 100 mg and E5555 200 mg
- 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
- 25 sitesJapan
- Study dates
- Oct 2007to Mar 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 use contraception).
- Confirmed coronary artery disease.
- All subjects must be receiving aspirin (75 - 325 mg).
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 or history of bleeding such as gastrointestinal or genitourinary, unless the cause has been definitely corrected.
- History of intracranial bleeding or history of hemorrhagic retinopathy.
- New York Heart Association class III or IV congestive heart failure.
- Pregnant or lactating women.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Japan25 sites
Study site
Asahikawa, Hokkaido
Study site
Bunkyo-ku, Tokyo
Study site
Chitose, Hokkaido
Study site
Gifu, Gifu
Study site
Himeji, Hyōgo
Study site
Ichinomiya, Aichi-ken
Study site
Kanazawa, Ishikawa-ken
Study site
Kitamoto, Saitama
Study site
Kumamoto, Kumamoto
Study site
Matsusaka, Mie-ken
Study site
Musashino, Tokyo
Study site
Nishinomiya, Hyōgo
Study site
Ōgaki, Gifu
Study site
Osaka, Osaka
Study site
Ōta-ku, Tokyo
Study site
Saitama, Saitama
Study site
Sapporo, Hokkaido
Study site
Sayama, Osaka
Study site
Shinjuku-ku, Tokyo
Study site
Shizuoka, Shizuoka
Study site
Tachikawa, Tokyo
Study site
Tomakomai, Hokkaido
Study site
Tsu, Mie-ken
Study site
Tsuchiura, Ibaraki
Study site
Yokohama, Kanagawa
About this study
The purpose of this study is to assess the safety and tolerability of E5555 in Japanese subjects with coronary artery disease.
- Conditions
- Coronary Artery Disease
- Being tested
- E5555 50 mg, E5555 100 mg, E5555 200 mg, Placebo
- Keywords
- Coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E5555 50 mgDrug
E5555 50 mg (tablet) taken orally, once a day.
E5555 100 mgDrug
E5555 100 mg (tablet) taken orally, once a day.
E5555 200 mgDrug
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 50 mg |
| 2 | Experimental | Not described Receives: Drug: E5555 100 mg |
| 3 | Experimental | Not described Receives: Drug: E5555 200 mg |
| 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: 6 months
Secondary outcomes (1)
Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- NCT00540670
- Sponsor's protocol ID
- E5555-J081-206
- Status last verified
- Feb 2010
- First submitted
- 4 Oct 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 Subjects With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00540670
- Acronym / sponsor ID
- E5555-J081-206
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Mar 2009 (actual)
- First posted
- 8 Oct 2007 (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 subjects with coronary artery disease.
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 50 mg |
| 2 | Experimental | Drug: E5555 100 mg |
| 3 | Experimental | Drug: E5555 200 mg |
| 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 (4 listed)
- 45 - 80 years old (at time of informed consent).
- Male or female (females of childbearing potential must use contraception).
- Confirmed coronary artery disease.
- All subjects must be receiving aspirin (75 - 325 mg).
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 or history of bleeding such as gastrointestinal or genitourinary, unless the cause has been definitely corrected.
- 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 |
|---|---|---|
| E5555 50 mgE5555 50 mg (tablet) taken orally, once a day. | Drug | 1 |
| E5555 100 mgE5555 100 mg (tablet) taken orally, once a day. | Drug | 2 |
| E5555 200 mgE5555 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: 6 months
1 secondary outcome
Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration.
Time frame: 6 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.
25 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 50 mg, E5555 100 mg and E5555 200 mg in people with Coronary Artery Disease, run by Eisai Co., Ltd. at 25 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 4 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 25 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: 6 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.