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

January 29, 2013
August 12, 2014
January 2013
August 2014   (final data collection date for primary outcome measure)
Major bleeding and Clinically Relevant Non-major bleeding [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01780987 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients
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

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)

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • 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
  • Experimental: Apixaban
    Intervention: Drug: Apixaban
  • Active Comparator: UFH/Warfarin
    Interventions:
    • Drug: Unfractionated Heparin (UFH)
    • Drug: Warfarin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01780987
B0661024, CV185160
Yes
Pfizer
Pfizer
Bristol-Myers Squibb
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP