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

PHASE3CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Deep Vein ThrombosisPulmonary Embolism
Interventions
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

Trial Locations (20)

480-1195

Aichi Medical University Hospital, Nagakute

285-8741

Toho University Sakura Medical Center, Sakura

802-8555

Kokura Memorial Hospital, Kitakyushu

960-1295

Fukushima Medical University Hospital, Fukushima

738-8503

Hiroshima General Hospital, Hatsukaichi

006-8555

Teine Keijinkai Hospital, Sapporo

920-0293

Kanazawa Medical University Hospital, Kahoku-gun

236-0037

Yokohama Minami Kyousai Hospital, Yokohama

245-8575

National Hospital Organization Yokohama Medical Center, Yokohama

860-8556

Kumamoto University Hospital, Kumamoto

861-4193

Saiseikai Kumamoto Hospital, Kumamoto

514-8507

Mie University Hospital, Tsu

701-1192

National Hospital Organization Okayama Medical Center, Okayama

589-8511

Kinki University Hospital, Sayama

565-8565

National Cerebral and Cardiovascular Center Hospital, Suita-shi

104-8560

St. Luke's International Hospital, Chuo-ku

173-8610

Nihon University Itabashi Hospital, Itabashi-ku

152-8902

National Hospital Organization Tokyo Medical Center, Meguro-ku

180-8610

Japanese Red Cross Musashino Hospital, Musashino

160-0023

Tokyo Medical University Hospital, Shinjuku-ku

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Pfizer

INDUSTRY

NCT01780987 - AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients | Biotech Hunter | Biotech Hunter