BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status

Atrial Fibrillation Clinical Trial

Official title:

BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00779064
• Other study ID #: 11390
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2008
• Last updated: December 23, 2014
• Start date: July 2004
• Est. completion date: June 2005

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 a clinical study investigating pharmacokinetics, pharmacodynamic effects and safety of BAY 59-7939 in patients with atrial fibrillation (originally described in Japanese).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 20 years or older

• Japanese male or female

• Non- valvular atrial fibrillation documented by ECG

• Patients aged 60 years and older or with a risk of stroke

Exclusion Criteria:

• Prior stroke and TIA

• Patients in whom anticoagulants are contraindicated

Study Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Rivaroxaban (BAY59-7939)
10mg BID, Semi-sequential, dose escalation.
• Rivaroxaban (BAY59-7939)
20mg BID, Semi-sequential, dose escalation.

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	Pharmacokinetics (PK) CL/f, AUC, Cmax, Pharmacodynamics (PD), Factor Xa activity, PT, PT-INR, aPTT and HEPTEST(R)		Day 14 and 28	No
Secondary	Each category of bleeding events and adverse event		Throughout treatment and followup period	Yes

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