BAY59-7939 in Atrial Fibrillation Once Daily (OD)

Atrial Fibrillation Clinical Trial

Official title:

BAY 59-7939 (Factor Xa Inhibitor) Phase II Once Daily Dose Study in Patients With Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973245
• Other study ID #: 11866
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2009
• Last updated: December 26, 2014
• Start date: July 2006
• Est. completion date: January 2007

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Xarelto (Rivaroxaban, BAY59-7939)
10mg od
• Xarelto (Rivaroxaban, BAY59-7939)
15mg od
• Xarelto (Rivaroxaban, BAY59-7939)
20mg od
• Warfarin
Dose-adjusted warfarin based on target INR values

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(Safety) Incidence of bleeding		Throughout treatment and followup period	Yes
Primary	(PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST		Day 14 and Day 28	Yes

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