A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-valvular Atrial Fibrillation
A Phase 2, Randomized, Parallel Group, Multi Center, Multi National Study for the Evaluation of Safety of Four Fixed Dose Regimens of DU-176b in Subjects With Non- Valvular Atrial Fibrillation
1 other identifier
interventional
1,146
11 countries
89
Brief Summary
This study is to assess the safety of a potential new drug DU-176b for the prevention of stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation (AF). The duration is 3 months of treatment and a 30 day follow-up visit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 atrial-fibrillation
Started Jun 2007
Shorter than P25 for phase_2 atrial-fibrillation
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 18, 2007
CompletedFirst Posted
Study publicly available on registry
July 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
March 13, 2015
CompletedFebruary 26, 2019
March 1, 2015
1 year
July 18, 2007
February 5, 2015
February 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adjudicated Incidence of Bleeding Events
Adjudicated Incidence of Bleeding Events during treatment period
3 months
Percent of Subjects With Liver-related Laboratory Marked Abnormalities (MA)
liver enzyme (ALT and/or AST) and/or bilirubin (TBL) abnormalities
3 months
Secondary Outcomes (10)
Incidence of Major Adverse Cardiac Events MACE)
3 months
Effects on Biomarker D-dimer
3 months
Effects on Biomarker Prothrombin Fragments
3 months
Pharmacokinetics (Cmin, Cmax) of DU-176b in Subjects Receiving DU-176b
3 months
Pharmacokinetics (AUC) of DU-176b in Subjects Receiving DU-176b
3 months
- +5 more secondary outcomes
Study Arms (5)
1
EXPERIMENTALDU-176b 30mg tablet once daily
2
EXPERIMENTALDU-176b 60mg once daily
3
EXPERIMENTALDU-176b 30mg b.i.d.
4
EXPERIMENTALDU-176b 60mg tablets two times a day
5
ACTIVE COMPARATORwarfarin tablets
Interventions
Eligibility Criteria
You may qualify if:
- Male or female, 18 to 80 years old.
- Able to provide written informed consent.
- Persistent non-valvular AF supported by abnormal electrocardiogram (ECG)
- A congestive heart failure, hypertension, age ≥ 75 years, diabetes, and prior stroke (CHADS2) index score of at least 2
You may not qualify if:
- Subjects with mitral valve disease or previous valvular heart surgery
- Known contraindication to any anticoagulant including vitamin K antagonists such as warfarin
- Known or suspected hereditary or acquired bleeding or coagulation disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (91)
Unknown Facility
Huntsville, Alabama, United States
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Anaheim, California, United States
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Beverly Hills, California, United States
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Stockton, California, United States
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Orlando, Florida, United States
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Sarasota, Florida, United States
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Atlanta, Georgia, United States
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Canton, Georgia, United States
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Fort Wayne, Indiana, United States
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Iowa City, Iowa, United States
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Cadillac, Michigan, United States
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Kalispell, Montana, United States
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Fremont, Nebraska, United States
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Santa Fe, New Mexico, United States
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Albany, New York, United States
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Oklahoma City, Oklahoma, United States
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Allentown, Pennsylvania, United States
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Pottstown, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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Dallas, Texas, United States
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Salt Lake City, Utah, United States
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Bellevue, Washington, United States
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Minsk, Belarus
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Brussels, Belgium
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Genk, Belgium
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Banja Luka, Bosnia and Herzegovina
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Mostar, Bosnia and Herzegovina
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Sarajevo, Bosnia and Herzegovina
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Tuzla, Bosnia and Herzegovina
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Alberta, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Oshawa, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Montreal, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Antofagasta, Chile
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Osorno, Chile
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Santiago, Chile
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Temuco, Chile
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Daugavpils, Latvia
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Riga, Latvia
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Ventspils, Latvia
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Córdoba, Mexico
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Guadalajara Jalisco, Mexico
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Mexico City, Mexico
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Chisinau, Moldova
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Arkhangelsk, Russia
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Barnaul, Russia
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Chelyabinsk, Russia
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Ivanovo, Russia
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Kaliningrad, Russia
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Kazan', Russia
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Kemerovo, Russia
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Krasnodar, Russia
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Krasnoyarsk, Russia
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Moscow, Russia
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N.Novgorod, Russia
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Novosibirsk, Russia
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Orenburg, Russia
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Penza, Russia
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Perm, Russia
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Rostov-on-Don, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Saratov, Russia
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Tomsk, Russia
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Tula, Russia
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Tyumen, Russia
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Volgograd, Russia
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Yaroslavl, Russia
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Bardejov, Slovakia
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Bratislava, Slovakia
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Košice, Slovakia
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Lučenec, Slovakia
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Prešov, Slovakia
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Cherkassy, Ukraine
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Chernihiv, Ukraine
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Chernivtsy, Ukraine
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Dnipro, Ukraine
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Donetsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kiev, Ukraine
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Lutsk, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Ternopil, Ukraine
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Vinnitsa, Ukraine
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Zaporizhzhya, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- William Maxwell, Assoc. Director
- Organization
- Daiichi Sankyo Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2007
First Posted
July 20, 2007
Study Start
June 1, 2007
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
February 26, 2019
Results First Posted
March 13, 2015
Record last verified: 2015-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
- Access Criteria
- Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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/