A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation - Full Text View

Sponsors and Collaborators:	Pfizer Bristol-Myers Squibb
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00787150

Purpose

To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on the composite endpoint of major and clinically relevant non-major bleeding during the treatment period.

Condition	Intervention	Phase
Atrial Fibrillation	Drug: Apixaban Drug: Warfarin sodium	Phase II

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Blood Thinners

Drug Information available for: Warfarin Apixaban Warfarin sodium Warfarin potassium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2b, Randomized, Partially Blind (Open Label Warfarin), Active-Controlled (Warfarin), Multicenter Study, To Evaluate The Safety And Efficacy In 2 Doses Of Apixaban In Comparison To Warfarin, Administered For 12 Weeks In Subjects With NVAF

Further study details as provided by Pfizer:

Primary Outcome Measures:

Incidence of adjudicated major or clinically relevant non-major bleeding during the treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of adjudicated myocardial infarction or all-cause death during the treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Incidence of major bleeding during the treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Other safety outcome measures will also be assessed, including serious and non-serious AEs and changes in standard clinical laboratory test results [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Incidence of adjudicated stroke or systemic embolism during the treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Incidence of adjudicated stroke, systemic embolism or all-cause death during the treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Incidence of total bleeding (major bleeding, clinically relevant non-major bleeding, and minor bleeding) during the treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	250
Study Start Date:	June 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Apixaban 5mg BID: Experimental	Drug: Apixaban Apixaban 5 mg tablet BID for 12 weeks
Apixaban 2.5mg BID: Experimental	Drug: Apixaban Apixaban 2.5 mg tablet BID for 12 weeks
Warfarin: Active Comparator	Drug: Warfarin sodium At each visit, the subject to take appropriate Warfarin tablet (on investigator's order) once a day every morning for 12 weeks

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age ≥ 20 years outpatient (regardless of sex)
Patients diagnosed as non-valvular atrial fibrillation (NVAF)
One or more following risks of stroke.

Exclusion Criteria:

Recent cerebral infarction (includes TIA) within 4 weeks of week 0.
Subjects who have or are suspected to have a serious/hereditary bleeding tendency, such as disseminated intravascular coagulation syndrome (DIC), congenital platelet dysfunction and von Willebrand disease (those suspected from the family history are included).
Subjects who have or are suspected to have a serious/hereditary thrombogenic tendency (those suspected from the family history are included) or those who require continuation of the Warfarin therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787150

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

Japan
Pfizer Investigational Site	Recruiting
Fukuoka, Japan
Pfizer Investigational Site	Recruiting
Kumamoto, Japan
Japan, Aichi
Pfizer Investigational Site	Recruiting
Seto, Aichi, Japan
Pfizer Investigational Site	Recruiting
Nagoya, Aichi, Japan
Japan, Ehime
Pfizer Investigational Site	Recruiting
Touon, Ehime, Japan
Japan, Fukuoka
Pfizer Investigational Site	Recruiting
kitakyushu, Fukuoka, Japan
Pfizer Investigational Site	Recruiting
Kitakyushu, Fukuoka, Japan
Japan, Gifu
Pfizer Investigational Site	Recruiting
Ogaki, Gifu, Japan
Japan, Gunma
Pfizer Investigational Site	Recruiting
Shibukawa, Gunma, Japan
Pfizer Investigational Site	Recruiting
Isezaki, Gunma, Japan
Japan, Hokkaido
Pfizer Investigational Site	Recruiting
Sapporo, Hokkaido, Japan
Japan, Ibaraki
Pfizer Investigational Site	Recruiting
Higashiibaraki-gunn Ibarakimachi, Ibaraki, Japan
Japan, Kagawa
Pfizer Investigational Site	Recruiting
Zentsuji, Kagawa, Japan
Japan, Kanagawa
Pfizer Investigational Site	Recruiting
Kawasaki, Kanagawa, Japan
Japan, Mie
Pfizer Investigational Site	Recruiting
Tsu, Mie, Japan
Japan, Tokyo
Pfizer Investigational Site	Recruiting
Shinjuku-ku, Tokyo, Japan
Pfizer Investigational Site	Recruiting
Minato-ku, Tokyo, Japan
Pfizer Investigational Site	Recruiting
Shinagawa-ku, Tokyo, Japan
Japan, Yamaguchi
Pfizer Investigational Site	Recruiting
Iwakuni, Yamaguchi, Japan

Sponsors and Collaborators

Pfizer

Bristol-Myers Squibb

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B0661003
Study First Received:	November 5, 2008
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00787150 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Anticoagulants
Heart Diseases
Warfarin
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Anticoagulants
Pathologic Processes
Heart Diseases
Therapeutic Uses
Hematologic Agents

Cardiovascular Diseases
Warfarin
Atrial Fibrillation
Pharmacologic Actions
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009