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
NCT ID: NCT00504556
Last Updated: 2019-02-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
1146 participants
INTERVENTIONAL
2007-06-30
2008-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
DU-176b Phase 2 Dose Finding Study in Subjects With Non-valvular Atrial Fibrillation
NCT00806624
Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation
NCT00781391
Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF)
NCT02072434
Safety and Efficacy of Edoxaban in Thoracoscopic Ablation
NCT04121767
Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (NVAF)
NCT03247569
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
DU-176b 30mg tablet once daily
Edoxaban (DU-176b)
30mg tablet once daily
2
DU-176b 60mg once daily
Edoxaban (DU-176b)
60mg tablet once daily
3
DU-176b 30mg b.i.d.
Edoxaban (DU-176b)
30mg tablet two times a day
4
DU-176b 60mg tablets two times a day
Edoxaban (DU-176b)
60mg tablet two times a day
5
warfarin tablets
warfarin
warfarin tablets
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Edoxaban (DU-176b)
30mg tablet once daily
Edoxaban (DU-176b)
60mg tablet once daily
Edoxaban (DU-176b)
30mg tablet two times a day
Edoxaban (DU-176b)
60mg tablet two times a day
warfarin
warfarin tablets
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Able to provide written informed consent.
3. Persistent non-valvular AF supported by abnormal electrocardiogram (ECG)
4. A congestive heart failure, hypertension, age ≥ 75 years, diabetes, and prior stroke (CHADS2) index score of at least 2
Exclusion Criteria
2. Known contraindication to any anticoagulant including vitamin K antagonists such as warfarin
3. Known or suspected hereditary or acquired bleeding or coagulation disorder
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Daiichi Sankyo
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Huntsville, Alabama, United States
Anaheim, California, United States
Beverly Hills, California, United States
Stockton, California, United States
Orlando, Florida, United States
Sarasota, Florida, United States
Atlanta, Georgia, United States
Canton, Georgia, United States
Fort Wayne, Indiana, United States
Iowa City, Iowa, United States
Cadillac, Michigan, United States
Kalispell, Montana, United States
Fremont, Nebraska, United States
Santa Fe, New Mexico, United States
Albany, New York, United States
Oklahoma City, Oklahoma, United States
Allentown, Pennsylvania, United States
Pottstown, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Bellevue, Washington, United States
Minsk, , Belarus
Brussels, , Belgium
Genk, , Belgium
Banja Luka, , Bosnia and Herzegovina
Mostar, , Bosnia and Herzegovina
Sarajevo, , Bosnia and Herzegovina
Tuzla, , Bosnia and Herzegovina
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Alberta, British Columbia, Canada
Winnipeg, Manitoba, Canada
Oshawa, Ontario, Canada
Thunder Bay, Ontario, Canada
Montreal, Quebec, Canada
Sherbrooke, Quebec, Canada
Antofagasta, , Chile
Osorno, , Chile
Santiago, , Chile
Temuco, , Chile
Daugavpils, , Latvia
Riga, , Latvia
Ventspils, , Latvia
Córdoba, , Mexico
Guadalajara Jalisco, , Mexico
Mexico City, , Mexico
Chisinau, , Moldova
Arkhangelsk, , Russia
Barnaul, , Russia
Chelyabinsk, , Russia
Ivanovo, , Russia
Kaliningrad, , Russia
Kazan', , Russia
Kemerovo, , Russia
Krasnodar, , Russia
Krasnoyarsk, , Russia
Moscow, , Russia
N.Novgorod, , Russia
Novosibirsk, , Russia
Orenburg, , Russia
Penza, , Russia
Perm, , Russia
Rostov-on-Don, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Saratov, , Russia
Tomsk, , Russia
Tula, , Russia
Tyumen, , Russia
Volgograd, , Russia
Yaroslavl, , Russia
Bardejov, , Slovakia
Bratislava, , Slovakia
Košice, , Slovakia
Lučenec, , Slovakia
Prešov, , Slovakia
Cherkassy, , Ukraine
Chernihiv, , Ukraine
Chernivtsy, , Ukraine
Dnipro, , Ukraine
Donetsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Kiev, , Ukraine
Lutsk, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Poltava, , Ukraine
Ternopil, , Ukraine
Vinnitsa, , Ukraine
Zaporizhzhya, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DU176b-PRT018
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.