check_circleStudy Completed

Atrial fibrillation

Bayer Identifier:

11866

ClinicalTrials.gov Identifier:

NCT00973245

EudraCT Number:

Not Available

EU CT Number:

Not Available
BAY59-7939 in Atrial Fibrillation Once daily (OD)

Trial purpose

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).

Key Participants Requirements

Sex

Both

Age

20 - N/A

  • 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.
  • - 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 summary

Enrollment Goal
102
Trial Dates
July 2006 - January 2007
Phase
Phase 2
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Kihara Cardiovascular and Internal HospitalAsahikawa, 078-8214, Japan
Completed
Saino ClinicTokorozawa, 359-1141, Japan
Completed
Kuwana City Hospital-Branch HospitalKuwana, 511-0068, Japan
Completed
Kobe Red Cross HospitalKobe, 651-0073, Japan
Completed
Fukuoka Postal Services Agency HospitalFukuoka, 810-8798, Japan
Completed
Saiseikai Futsukaichi HospitalChikushino, 818-8516, Japan
Completed
Tohoku Kosai HospitalSendai, 980-0803, Japan
Completed
Dobashi Medical ClinicSendai, 980-0871, Japan
Completed
Tokyo Heart CenterShinagawa-ku, 141-0001, Japan
Completed
Takarazuka HospitalTakarazuka, 665-0022, Japan
Completed
Nishio HospitalNogata, 822-0026, Japan

Primary Outcome

  • (Safety) Incidence of bleeding
    date_rangeTime Frame:
    Throughout treatment and followup period
    enhanced_encryption
    Safety Issue:
    yes
  • (PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST
    date_rangeTime Frame:
    Day 14 and Day 28
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

BAY 59-7939 (Factor Xa inhibitor) Phase II once daily dose study in patients with atrial fibrillation
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

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