Non-valvular Atrial FibrillationPhase 3NCT01857622
Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal Impairment
A Phase 3 study testing DU-176b 15mg, DU-176b 30mg and DU-176b 60mg in people with Non-valvular Atrial Fibrillation, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.
Trial summary
To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial fibrillation patients with severe renal impairment, compared with DU-176b administered to non-valvular atrial fibrillation (NVAF) patients with normal renal function or mild renal impairment (Normal/MiRI). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation
- What is being tested?
- DU-176b 15mg, DU-176b 30mg and DU-176b 60mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2011to Jan 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with NVAF and SRI, or patients with NVAF and Normal/MiRI.
Who cannot join
- Patients who are on hemodialysis or patients who may start hemodialysis before the follow-up assessment
- Patients who are at a significantly high risk for bleeding
- Patients who are receiving treatment with any anticoagulant drugs excluding warfarin, rivaroxaban, and dabigatran
- Patients who have evidence of hepatic function test abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Clinical Study of DU-176b (Non-valvular Atrial Fibrillation): Japanese, Multicenter, Open-label Study of DU-176b in Patients With Non-valvular Atrial Fibrillation and Severe Renal Impairment (SRI)
To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial fibrillation patients with severe renal impairment, compared with DU-176b administered to non-valvular atrial fibrillation (NVAF) patients with normal renal function or mild renal impairment (Normal/MiRI).
- Conditions
- Non-valvular Atrial Fibrillation
- Being tested
- DU-176b 15mg, DU-176b 30mg, DU-176b 60mg
- Keywords
- anticoagulant, DU-176b, edoxaban, factor Xa, oral, atrial fibrillation, severe renal impairment
- Medical subject headings
- Atrial Fibrillation, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DU-176b 15mgDrug
Also called edoxaban
oral DU-176b 15mg once daily
DU-176b 30mgDrug
Also called edoxaban
oral DU-176b 30mg once daily
DU-176b 60mgDrug
Also called edoxaban
oral DU-176b 60mg once daily
| Study group | Role | What they receive |
|---|---|---|
| SRI 15mg | Experimental | DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks. Receives: Drug: DU-176b 15mg |
| Normal/MiRI low-dose group | Experimental | DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors. Receives: Drug: DU-176b 30mg |
| Normal/MiRI high-dose group | Experimental | DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors. Receives: Drug: DU-176b 60mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Any Adjudicated Bleeding Events
Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding)
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 May 2013 (estimated)
- Study startNov 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-valvular Atrial FibrillationStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yukihiro Koretsune, Dir, Principal investigator, Osaka National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857622
- Sponsor's protocol ID
- DU176b-B-J307
- Status last verified
- Jan 2015
- First submitted
- 16 May 2013
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Study of DU-176b (Non-valvular Atrial Fibrillation): Japanese, Multicenter, Open-label Study of DU-176b in Patients With Non-valvular Atrial Fibrillation and Severe Renal Impairment (SRI)
- ClinicalTrials.gov ID
- NCT01857622
- Acronym / sponsor ID
- DU176b-B-J307
- Conditions
- Non-valvular Atrial Fibrillation
- Keywords
- anticoagulant, DU-176b, edoxaban, factor Xa, oral, atrial fibrillation, severe renal impairment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 20 May 2013 (estimated)
- Results
- Posted 26 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial fibrillation patients with severe renal impairment, compared with DU-176b administered to non-valvular atrial fibrillation (NVAF) patients with normal renal function or mild renal impairment (Normal/MiRI).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SRI 15mg | Experimental | Drug: DU-176b 15mgDU-176b was orally administered at a dose of 15 mg once daily for 12 weeks. |
| Normal/MiRI low-dose group | Experimental | Drug: DU-176b 30mgDU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors. |
| Normal/MiRI high-dose group | Experimental | Drug: DU-176b 60mgDU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with NVAF and SRI, or patients with NVAF and Normal/MiRI.
Key exclusion criteria (4 listed)
- Patients who are on hemodialysis or patients who may start hemodialysis before the follow-up assessment
- Patients who are at a significantly high risk for bleeding
- Patients who are receiving treatment with any anticoagulant drugs excluding warfarin, rivaroxaban, and dabigatran
- Patients who have evidence of hepatic function test abnormalities
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 |
|---|---|---|
| DU-176b 15mgAlso: edoxabanoral DU-176b 15mg once daily | Drug | SRI 15mg |
| DU-176b 30mgAlso: edoxabanoral DU-176b 30mg once daily | Drug | Normal/MiRI low-dose group |
| DU-176b 60mgAlso: edoxabanoral DU-176b 60mg once daily | Drug | Normal/MiRI high-dose group |
Primary outcome
Incidence of Any Adjudicated Bleeding Events
Time frame: 3 months
Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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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.
Yukihiro Koretsune, Dir principal investigator
Osaka National Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DU-176b 15mg, DU-176b 30mg and DU-176b 60mg in people with Non-valvular Atrial Fibrillation, run by Daiichi Sankyo Co., Ltd. at 1 site 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 1 inclusion and 4 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 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Any Adjudicated Bleeding Events (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 5 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.