- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00973245
BAY59-7939 in Atrial Fibrillation Once Daily (OD)
December 26, 2014 updated by: Bayer
BAY 59-7939 (Factor Xa Inhibitor) Phase II Once Daily Dose Study in Patients With Atrial Fibrillation
This is an exploratory investigation of safety, pharmacokinetic (PK) and pharmacodynamic (PD) effects of BAY59-7939 with multiple oral doses of 10 mg, 15 mg and 20 mg once daily (od) in Japanese subjects with non-valvular atrial fibrillation (originally described in Japanese).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fukuoka, Japan, 810-8798
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Fukuoka
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Chikushino, Fukuoka, Japan, 818-8516
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Nogata, Fukuoka, Japan, 822-0026
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Hokkaido
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Asahikawa, Hokkaido, Japan, 078-8214
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Hyogo
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Kobe, Hyogo, Japan, 651-0073
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Takarazuka, Hyogo, Japan, 665-0022
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Mie
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Kuwana, Mie, Japan, 511-0068
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Miyagi
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Sendai, Miyagi, Japan, 980-0803
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Sendai, Miyagi, Japan, 980-0871
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Saitama
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Tokorozawa, Saitama, Japan, 359-1141
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Tokyo
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Shinagawa-ku, Tokyo, Japan, 141-0001
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Japanese subjects with non-valvular AF who met all of the following criteria:
- Male subjects aged 20 years or older and postmenopausal female subjects
- Subjects with persistent or paroxysmal non-valvular AF with >/=2 episodes before enrollment, at least 1 of which had been verified by ECG recording within 4 weeks before randomization
- Subjects who were at risk for stroke as follows:
- Subjects with at least one risk factor for thromboembolism (hypertension, diabetes mellitus, coronary artery disease, congestive heart failure).
- Subjects aged 60 years old and above regardless of the existence of above risk factors.
Exclusion Criteria:
- History or presence of stroke or transient ischemic attack.
- History of intracerebral hemorrhage.
- History or presence of bleeding at randomization; intraocular or gastrointestinal bleeding within the last 6 months prior to randomization.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm 1
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10mg od
15mg od
20mg od
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Experimental: Arm 2
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10mg od
15mg od
20mg od
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Experimental: Arm 3
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10mg od
15mg od
20mg od
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Active Comparator: Arm 4
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Dose-adjusted warfarin based on target INR values
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
(Safety) Incidence of bleeding
Time Frame: Throughout treatment and followup period
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Throughout treatment and followup period
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(PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST
Time Frame: Day 14 and Day 28
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Day 14 and Day 28
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
September 8, 2009
First Submitted That Met QC Criteria
September 8, 2009
First Posted (Estimate)
September 9, 2009
Study Record Updates
Last Update Posted (Estimate)
December 30, 2014
Last Update Submitted That Met QC Criteria
December 26, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11866
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Fibrillation
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AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
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Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
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Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
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Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
-
Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
-
Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
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St. George's Hospital, LondonRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial ArrhythmiaUnited Kingdom
-
R-PharmFSBI "National Medical Research Center of Cardiology named after academician...CompletedAtrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationRussian Federation
-
Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
Clinical Trials on Warfarin
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University Hospital, BrestCompleted
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University Hospital, BrestCompletedRecurrent Venous Thromboembolism | Idiopathic Deep Vein ThrombosisFrance
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University of PadovaCompleted
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloCompletedAtrial FibrillationBrazil
-
National University Hospital, SingaporeUnknownIndications for Warfarin TherapySingapore, Malaysia
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI); Duke Clinical Research InstituteTerminatedIdiopathic Pulmonary FibrosisUnited States
-
Azienda Ospedaliera Universitaria PoliclinicoCompletedDeep Vein ThrombosisItaly
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University of KarachiAdvanced Education & Research Center; Karachi Institute of Heart DiseasesRecruitingLeft Atrial Appendage Aneurysm | Mitral StenosisPakistan
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Jonsson Comprehensive Cancer CenterNovartis PharmaceuticalsCompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
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Massachusetts General HospitalNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases | Cerebrovascular Disorders | Atrial Fibrillation | Arrhythmia | Cerebrovascular Accident | Thrombophlebitis | Cerebral Embolism and Thrombosis