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

Pulmonary Embolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780987
• Other study ID #: B0661024
• Secondary ID: CV185160BMS
• Status: Completed
• Phase: Phase 3
• First received: January 29, 2013
• Last updated: February 9, 2015
• Start date: January 2013
• Est. completion date: September 2014

Study information

• Verified date: February 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Japan	St. Luke's International Hospital	Chuo-ku	Tokyo
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Hiroshima General Hospital	Hatsukaichi	Hiroshima
Japan	Nihon University Itabashi Hospital	Itabashi-ku	Tokyo
Japan	Kanazawa Medical University Hospital	Kahoku-gun	Ishikawa
Japan	Kokura Memorial Hospital	Kitakyusyu	Fukuoka
Japan	Kumamoto University Hospital	Kumamoto
Japan	Saiseikai Kumamoto Hospital	Kumamoto
Japan	National Hospital Organization Tokyo Medical Center	Meguro-ku	Tokyo
Japan	Japanese Red Cross Musashino Hospital	Musashino	Tokyo
Japan	Aichi Medical University Hospital	Nagakute	Aichi
Japan	National Hospital Organization Okayama Medical Center	Okayama City	Okayama
Japan	Kinki University Hospital	Osakasayama	Osaka
Japan	Toho University Sakura Medical Center	Sakura	Chiba
Japan	Teine Keijinkai Hospital	Sapporo	Hokkaido
Japan	Tokyo Medical University Hospital	Shinjuku-ku	Tokyo
Japan	National Cerebral and Cardiovascular Center Hospital	Suita-shi	Osaka
Japan	Mie University Hospital	Tsu	Mie
Japan	National Hospital Organization Yokohama Medical Center	Yokohama	Kanagawa
Japan	Yokohama Minami Kyousai Hospital	Yokohama	Kanagawa

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major bleeding and Clinically Relevant Non-major bleeding		24 weeks	Yes
Secondary	symptomatic VTE or VTE-related death		24 weeks	No
Secondary	thrombtic burden deterioration		24 weeks	No
Secondary	Major bleeeding		24 weeks	Yes
Secondary	All bleeding		24 weeks	Yes

External Links

•   To obtain contact information for a study center near you, click here.