Atrial FibrillationPhase 2NCT00829933
Late Phase 2 Study of DU-176b in Patients With Non-Valvular Atrial Fibrillation
A Phase 2 study testing DU-176b tablets and Warfarin potassium tablets in people with Atrial Fibrillation, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.
Trial summary
The primary objective of this study is to compare the incidence of hemorrhagic events in patients treated for non-valvular atrial fibrillation with DU-176b at each dose level versus warfarin potassium (warfarin). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- DU-176b tablets and Warfarin potassium tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2007to Sep 2008
- Phase
- Phase 2
- 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 non-valvular atrial fibrillation who meet all of the following requirements will be considered for admission to the study:
- Age≧20years
- Atrial fibrillation confirmed by at least 2 electrocardiographic(ECG) tracings taken at an interval of ≧1week during the year before enrollment
- Presence of any (at least )one of the following risk factors for embolism:
- Hypertension
- Diabetes mellitus
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- Congestive heart failure
- Previous transient ischemic attack (TIA) or cerebral infarction (more than 30 days before giving informed consent )
- Age≧75 years
- At time of giving informed consent.
- To be confirmed on ECG charts, etc.
Who cannot join
- Presence of any of the following conditions with increased risk of hemorrhage:
- History of intracranial, intraocular (excluding bleeding beneath the bulbar conjunctiva ), intrathecal, retroperitoneal, or non-traumatic intraarticular hemorrhage
- History of gastrointestinal hemorrhage during the year before giving informed consent
- History of peptic ulcers during the 90 days before giving informed consent
- Surgical treatment or trauma requiring hospitalization during the 30 days before giving informed consent
- Hemoglobin level <10 g/dL platelet count <10 ×10000 /μL at screening examinations
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- Active hemorrhage* present at giving informed consent or at enrollment
- Any invasive therapeutic or diagnostic procedure (e.g., surgery, tissue, biopsy, and tooth extraction) scheduled during the period from the time of informed consent until completion of the trial treatment.
- Any congenital hemorrhagic disease
- History of cerebral infarction or TIA within 30 days before giving informed consent
- Current treatment with any anticoagulant(other than warfarin)
- Concurrent rheumatic valvular disease
- History of valvular surgery
- Concurrent infectious endocarditis
- Concurrent cardiac myxoma
- Confirmed left ventricular or left atrial thrombosis
- Any congenital condition with a tendency toward thrombosis
- Electrical or pharmacological defibrillation scheduled during the trial treatment
- Uncontrolled hypertension (persistently high systolic ［>160mmHg］or diastolic [>100mmHg] pressure)
- Uncontrolled diabetes mellitus
- Renal or hepatic dysfunction (as defined below ), confirmed at screening examinations
- Serum creatinine>1.5mg/dL
- AST(GOT)or ALT(GPT)≧twice the upper limit of the reference range
- Total bilirubin ≧twice the upper limit of the reference range
- Current antiplatelet therapy for any concomitant illness that may be aggravated after discontinuation of the therapy.
- Any concurrent severe cardiac disease
- Known allergy to warfarin or any condition contraindicating its use
- Inability to discontinue current treatment with vitamin K
- Confirmed or potential pregnancy, wish to become pregnant during the study period, or current breast feeding
- Previous treatment with DU-176b
- Participation in a trial of any other drug during the 6 month before giving informed consent
- Any other condition that disqualifies the patient for the study in the opinion of the investigator/subinvestigator *This includes ecchymosis identified as at least one hematoma sized ≧5 cm in longer diameter, macroscopic hematuria, and microscopic hematuria defined as a ≧2+test or a 1+ test for occult blood with a urine sediment containing ≧10 red cells per high-power field (except for a 2+ occult blood test persisting for 1 year before giving informed consent).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Dose-ranging Controlled Trial of DU-176b Versus Warfarin Potassium in Patients With Non-valvular Atrial Fibrillation
The primary objective of this study is to compare the incidence of hemorrhagic events in patients treated for non-valvular atrial fibrillation with DU-176b at each dose level versus warfarin potassium (warfarin). The secondary objective includes between-group comparisons with regard to incidence of thromboembolic events, pharmacodynamic parameters, and biomarkers for the efficacy evaluation, as well as incidence of adverse events and adverse reaction for the safety evaluation.
- Conditions
- Atrial Fibrillation
- Being tested
- DU-176b tablets, Warfarin potassium tablets
- Keywords
- Atrial fibrillation, Factor Xa inhibition
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DU-176b tabletsDrug
DU-176b tablets taken once daily for up to 12 weeks
Warfarin potassium tabletsDrug
Warfarin potassium tablets taken once daily for up to 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | DU-176b low dose Receives: Drug: DU-176b tablets |
| 2 | Experimental | DU-176b intermediate dose Receives: Drug: DU-176b tablets |
| 3 | Experimental | DU-176b high dose Receives: Drug: DU-176b tablets |
| 4 | Active comparator | Warfarin Receives: Drug: Warfarin potassium tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Bleeding Events (Major Bleeding, Clinically Relevant Non-major Bleeding and Minor Bleeding ) Identified During the Period From the Entry Into the Treatment Period Until Completion or Termination of the Treatment.
The primary endpoint was the incidence of bleeding events (major bleeding, clinically relevant non-major bleeding, or minor bleeding) that occurred during the treatment period.
Measured: 12 weeks
Secondary outcomes (5)
Incidence of Thromboembolic Events (Cerebral Infarction and Systemic Embolism) Identified During the Period From the Entry to the Treatment Period Until Completion or Termination of the Treatment.
Measured: 12 weeks
Incidence of Adverse Events and Adverse Reactions Identified During the Period From the Entry to the Treatment Period Until Completion or Termination of the Treatment
Measured: 12 weeks
Pharmacodynamic Parameters (PT, PT-INR, and APTT)
PT - prothrombin time INR - International Normalized Ratio APTT - Activated Partial Thromboplastin time
Measured: 12 weeks
Plasma DU-176 Concentration
Measured: 12 weeks
Pharmacodynamic Biomarkers (F1+2, TAT, and D-dimer )
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startMar 2007
- Primary completionJul 2008
- Study completionSep 2008
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 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829933
- Sponsor's protocol ID
- DU176b-C-J225
- Status last verified
- Feb 2015
- First submitted
- 26 Jan 2009
- Last updated
- 25 Feb 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 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Dose-ranging Controlled Trial of DU-176b Versus Warfarin Potassium in Patients With Non-valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00829933
- Acronym / sponsor ID
- DU176b-C-J225
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Factor Xa inhibition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 27 Jan 2009 (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.
The primary objective of this study is to compare the incidence of hemorrhagic events in patients treated for non-valvular atrial fibrillation with DU-176b at each dose level versus warfarin potassium (warfarin). The secondary objective includes between-group comparisons with regard to incidence of thromboembolic events, pharmacodynamic parameters, and biomarkers for the efficacy evaluation, as well as incidence of adverse events and adverse reaction for the safety evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DU-176b tabletsDU-176b low dose |
| 2 | Experimental | Drug: DU-176b tabletsDU-176b intermediate dose |
| 3 | Experimental | Drug: DU-176b tabletsDU-176b high dose |
| 4 | Active comparator | Drug: Warfarin potassium tabletsWarfarin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with non-valvular atrial fibrillation who meet all of the following requirements will be considered for admission to the study:
- Presence of any (at least )one of the following risk factors for embolism:
Key exclusion criteria (32 listed)
- Presence of any of the following conditions with increased risk of hemorrhage:
- History of cerebral infarction or TIA within 30 days before giving informed consent
- Current treatment with any anticoagulant(other than warfarin)
- Concurrent rheumatic valvular disease
- History of valvular surgery
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 tabletsDU-176b tablets taken once daily for up to 12 weeks | Drug | 1, 2, 3 |
| Warfarin potassium tabletsWarfarin potassium tablets taken once daily for up to 12 weeks | Drug | 4 |
Primary outcome
Incidence of Bleeding Events (Major Bleeding, Clinically Relevant Non-major Bleeding and Minor Bleeding ) Identified During the Period From the Entry Into the Treatment Period Until Completion or Termination of the Treatment.
Time frame: 12 weeks
The primary endpoint was the incidence of bleeding events (major bleeding, clinically relevant non-major bleeding, or minor bleeding) that occurred during the treatment period.
5 secondary outcomes
Incidence of Thromboembolic Events (Cerebral Infarction and Systemic Embolism) Identified During the Period From the Entry to the Treatment Period Until Completion or Termination of the Treatment.
Time frame: 12 weeks
Incidence of Adverse Events and Adverse Reactions Identified During the Period From the Entry to the Treatment Period Until Completion or Termination of the Treatment
Time frame: 12 weeks
Pharmacodynamic Parameters (PT, PT-INR, and APTT)
Time frame: 12 weeks
Plasma DU-176 Concentration
Time frame: 12 weeks
Pharmacodynamic Biomarkers (F1+2, TAT, and D-dimer )
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DU-176b tablets and Warfarin potassium tablets in people with 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 11 inclusion and 32 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 25 Feb 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 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?
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 Bleeding Events (Major Bleeding, Clinically Relevant Non-major Bleeding and Minor Bleeding ) Identified During the Period From the Entry Into the Treatment Period Until Completion or Termination of the Treatment. (time frame: 12 weeks). 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 25 Feb 2019.