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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

Page last updated: August 23, 2015

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