AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to investigate safety of apixaban in Japanese acute DVT/PE subjects when symptomatic DVT/PE subjects are treated with 10 mg BID apixaban for 7 days as initial therapy followed by 5 mg BID apixaban for 23 weeks as long-term therapy (total treatment period is 24 weeks)
Condition	Deep Vein Thrombosis Pulmonary Embolism
Intervention	Drug: Apixaban Drug: Unfractionated Heparin (UFH) Drug: Warfarin
Phase	Phase 3
Sponsor	Pfizer
Responsible Party	Pfizer
ClinicalTrials.gov Identifier	NCT01780987
First Received	January 29, 2013
Last Updated	April 20, 2014
Last verified	April 2014

First Received Date	January 29, 2013
Last Updated Date	April 20, 2014
Start Date	January 2013
Estimated Primary Completion Date	August 2014
Current Primary Outcome Measures	Major bleeding and Clinically Relevant Non-major bleeding [Time Frame: 24 weeks] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	symptomatic VTE or VTE-related death [Time Frame: 24 weeks] [Designated as safety issue: No] thrombtic burden deterioration [Time Frame: 24 weeks] [Designated as safety issue: No] Major bleeeding [Time Frame: 24 weeks] [Designated as safety issue: Yes] All bleeding [Time Frame: 24 weeks] [Designated as safety issue: Yes]

Brief Title	AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients
Official Title	Active-Control, Multicenter, Randomized, Open-Label, Safety And Efficacy Study Evaluating The Use Of Apixaban In The Treatment Of Symptomatic Deep Vein Thrombosis And Pulmonary Embolism In Japanese
Brief Summary	The purpose of this study is to investigate safety of apixaban in Japanese acute DVT/PE subjects when symptomatic DVT/PE subjects are treated with 10 mg BID apixaban for 7 days as initial therapy followed by 5 mg BID apixaban for 23 weeks as long-term therapy (total treatment period is 24 weeks)
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Deep Vein Thrombosis Pulmonary Embolism
Intervention	Drug: Apixaban 10 mg BID for 7 days followed by 5 mg BID for 23 weeks (total 24 weeks) Drug: 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 Drug: Warfarin Dosing for 24 weeks to target INR range between 1.5-2.5
Study Arm (s)	Experimental: Apixaban Active Comparator: UFH/Warfarin

Recruitment Status	Active, not recruiting
Estimated Enrollment	80
Estimated Completion Date	August 2014
Estimated Primary Completion Date	August 2014
Eligibility Criteria	Inclusion Criteria: - Acute symptomatic proximal DVT with evidence of proximal thrombosis - Acute symptomatic PE with evidence of thrombosis in segmental or more proximal branches Exclusion Criteria: - Active bleeding or high risk for bleeding contraindicating treatment with UFH and a VKA. - Uncontrolled hypertension: systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg - Subjects requiring dual anti-platelet therapy
Gender	Both
Ages	20 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Japan

NCT Number	NCT01780987
Other Study ID Numbers	B0661024
Has Data Monitoring Committee	Yes
Information Provided By	Pfizer
Study Sponsor	Pfizer
Collaborators	Bristol-Myers Squibb
Investigators	Study Director: Pfizer CT.gov Call Center Pfizer
Verification Date	April 2014

Aichi Medical University Hospital	Nagakute, Aichi, Japan
Toho University Sakura Medical Center	Sakura, Chiba, Japan
Kokura Memorial Hospital	Kitakyusyu, Fukuoka, Japan
Hiroshima General Hospital	Hatsukaichi, Hiroshima, Japan
Teine Keijinkai Hospital	Sapporo, Hokkaido, Japan
Kanazawa Medical University Hospital	Kahoku-gun, Ishikawa, Japan
National Hospital Organization Kanazawa Medical Center	Kanazawa, Ishikawa, Japan
National Hospital Organization Yokohama Medical Center	Yokohama, Kanagawa, Japan
Yokohama Minami Kyousai Hospital	Yokohama, Kanagawa, Japan
Mie University Hospital	Tsu, Mie, Japan
National Hospital Organization Okayama Medical Center	Okayama City, Okayama, Japan
Kinki University Hospital	Osakasayama, 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
Fukushima Medical University Hospital	Fukushima, Japan
Saiseikai Kumamoto Hospital	Kumamoto, Japan
Kumamoto University Hospital	Kumamoto, Japan
Kumamoto City Hospital	Kumamoto, Japan
Nagasaki Municipal Hospital	Nagasaki, Japan