BAY59-7939 Japanese in Atrial Fibrillation (2nd)
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: Xarelto (Rivaroxaban, BAY59-7939) (Drug); Xarelto (Rivaroxaban, BAY59-7939) (Drug); Xarelto (Rivaroxaban, BAY59-7939) (Drug); Warfarin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Summary
This study was a randomized, parallel group, open label trial using warfarin as comparator.
Pharmacokinetics (PK) and pharmacodynamics (PD) were investigated only in BAY59-7939 groups
(originally described in Japanese).
Clinical Details
Official title: BAY 59-7939 (Factor Xa Inhibitor) Phase II Low Dose Study in Patients With Atrial Fibrillation
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: (Safety) Incidence of bleeding(PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Japanese subjects with non-valvular AF who met all of the following criteria:
- 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
- Male subjects aged 20 years or older and postmenopausal female subjects
- Subjects with at least one risk factor for thromboembolism or aged 60 years or
older (Risk factor for thromboembolism: hypertension, diabetes mellitus,
coronary artery disease, congestive heart failure).
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.
Locations and Contacts
Fukui 910-0005, Japan
Oita 870-0192, Japan
Kurume, Fukuoka 830-8577, Japan
Maebaru, Fukuoka 819-1104, Japan
Kitahiroshima, Hokkaido 061-1134, Japan
Kushiro, Hokkaido 085-0831, Japan
Sapporo, Hokkaido 064-0807, Japan
Nomi, Ishikawa 923-1100, Japan
Yokohama, Kanagawa 227-0046, Japan
Tokorozawa, Saitama 359-1141, Japan
Additional Information
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Starting date: September 2005
Last updated: December 26, 2014
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