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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01780987
First received: January 29, 2013
Last updated: August 12, 2014
Last verified: August 2014
  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 Intervention Phase
Deep Vein Thrombosis
Pulmonary Embolism
Drug: Apixaban
Drug: Unfractionated Heparin (UFH)
Drug: Warfarin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Major bleeding and Clinically Relevant Non-major bleeding [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

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 ]

Estimated Enrollment: 80
Study Start Date: January 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apixaban Drug: Apixaban
10 mg BID for 7 days followed by 5 mg BID for 23 weeks (total 24 weeks)
Active Comparator: UFH/Warfarin 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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780987

Locations
Japan
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 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
Sponsors and Collaborators
Pfizer
Bristol-Myers Squibb
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01780987     History of Changes
Other Study ID Numbers: B0661024, CV185160
Study First Received: January 29, 2013
Last Updated: August 12, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
DVT
PE
VTE

Additional relevant MeSH terms:
Thrombosis
Pulmonary Embolism
Venous Thrombosis
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Calcium heparin
Warfarin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 30, 2014