Trial record 19 of 86 for:    Open Studies | "Pulmonary Embolism"

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

This study is currently recruiting participants.
Verified March 2014 by Pfizer
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01780987
First received: January 29, 2013
Last updated: March 17, 2014
Last verified: March 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780987

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Japan
Aichi Medical University Hospital Active, not recruiting
Nagakute, Aichi, Japan
Toho University Sakura Medical Center Recruiting
Sakura, Chiba, Japan
Kokura Memorial Hospital Recruiting
Kitakyusyu, Fukuoka, Japan
Hiroshima General Hospital Recruiting
Hatsukaichi, Hiroshima, Japan
Teine Keijinkai Hospital Recruiting
Sapporo, Hokkaido, Japan
Kanazawa Medical University Hospital Recruiting
Kahoku-gun, Ishikawa, Japan
National Hospital Organization Kanazawa Medical Center Recruiting
Kanazawa, Ishikawa, Japan
National Hospital Organization Yokohama Medical Center Recruiting
Yokohama, Kanagawa, Japan
Yokohama Minami Kyousai Hospital Recruiting
Yokohama, Kanagawa, Japan
Mie University Hospital Recruiting
Tsu, Mie, Japan
National Hospital Organization Okayama Medical Center Recruiting
Okayama City, Okayama, Japan
Kinki University Hospital Active, not recruiting
Osakasayama, Osaka, Japan
National Cerebral and Cardiovascular Center Hospital Recruiting
Suita-shi, Osaka, Japan
St. Luke's International Hospital Recruiting
Chuo-ku, Tokyo, Japan
Nihon University Itabashi Hospital Recruiting
Itabashi-ku, Tokyo, Japan
National Hospital Organization Tokyo Medical Center Recruiting
Meguro-ku, Tokyo, Japan
Japanese Red Cross Musashino Hospital Recruiting
Musashino, Tokyo, Japan
Tokyo Medical University Hospital Recruiting
Shinjuku-ku, Tokyo, Japan
Fukushima Medical University Hospital Recruiting
Fukushima, Japan
Kumamoto University Hospital Recruiting
Kumamoto, Japan
Saiseikai Kumamoto Hospital Recruiting
Kumamoto, Japan
Kumamoto City Hospital Recruiting
Kumamoto, Japan
Nagasaki Municipal Hospital Not yet recruiting
Nagasaki, 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: March 17, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
DVT
PE
VTE

Additional relevant MeSH terms:
Pulmonary Embolism
Embolism
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Calcium heparin
Heparin
Warfarin
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 April 15, 2014