BAY59-7939 in Atrial Fibrillation Once Daily (OD)

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Bayer

Status and phase

Completed
Phase 2

Conditions

Atrial Fibrillation

Treatments

Drug: Xarelto (Rivaroxaban, BAY59-7939)
Drug: Warfarin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00973245
11866

Details and patient eligibility

About

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).

Enrollment

102 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

102 participants in 4 patient groups

Arm 1
Experimental group
Treatment:
Drug: Xarelto (Rivaroxaban, BAY59-7939)
Arm 2
Experimental group
Treatment:
Drug: Xarelto (Rivaroxaban, BAY59-7939)
Arm 4
Active Comparator group
Treatment:
Drug: Warfarin
Arm 3
Experimental group
Treatment:
Drug: Xarelto (Rivaroxaban, BAY59-7939)

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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