AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients
NCT ID: NCT01780987
Last Updated: 2016-06-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
80 participants
INTERVENTIONAL
2013-01-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Apixaban
Apixaban
10 mg BID for 7 days followed by 5 mg BID for 23 weeks (total 24 weeks)
UFH/Warfarin
Unfractionated Heparin (UFH)
Dosing adjustment based on APTT = 1.5-2.5 times the control value, and until INR ≥ 1.5 for 5 days or more
Warfarin
Dosing for 24 weeks to target INR range between 1.5-2.5
Interventions
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Apixaban
10 mg BID for 7 days followed by 5 mg BID for 23 weeks (total 24 weeks)
Unfractionated Heparin (UFH)
Dosing adjustment based on APTT = 1.5-2.5 times the control value, and until INR ≥ 1.5 for 5 days or more
Warfarin
Dosing for 24 weeks to target INR range between 1.5-2.5
Eligibility Criteria
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Inclusion Criteria
* Acute symptomatic PE with evidence of thrombosis in segmental or more proximal branches
Exclusion Criteria
* Uncontrolled hypertension: systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 110 mm Hg
* Subjects requiring dual anti-platelet therapy
20 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Aichi Medical University Hospital
Nagakute, Aichi-ken, Japan
Toho University Sakura Medical Center
Sakura, Chiba, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Hiroshima General Hospital
Hatsukaichi, Hiroshima, Japan
Teine Keijinkai Hospital
Sapporo, Hokkaido, Japan
Kanazawa Medical University Hospital
Kahoku-gun, Ishikawa-ken, Japan
Yokohama Minami Kyousai Hospital
Yokohama, Kanagawa, Japan
National Hospital Organization Yokohama Medical Center
Yokohama, Kanagawa, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
National Hospital Organization Okayama Medical Center
Okayama, Okayama-ken, Japan
Kinki University Hospital
Sayama, Osaka, Japan
National Cerebral and Cardiovascular Center Hospital
Suita-shi, Osaka, Japan
St. Luke's International Hospital
Chuo-ku, Tokyo, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, Japan
Japanese Red Cross Musashino Hospital
Musashino, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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CV185160
Identifier Type: OTHER
Identifier Source: secondary_id
B0661024
Identifier Type: -
Identifier Source: org_study_id
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