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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Aichi Medical University Hospital
Nagakute, Aichi, 480-1195 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Deep Vein Thrombosis, Pulmonary Embolism
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Acute symptomatic proximal DVT with evidence of proximal thrombosis

- Acute symptomatic PE with evidence of thrombosis in segmental or more proximal
branches

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01780987
Pfizer
Completed
AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients

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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
Intervention Model: Parallel Assignment
Masking: None (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.
 
Completed
80
September 2014
September 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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01780987
B0661024
CV185160 ( Other Identifier: BMS )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Bristol-Myers Squibb
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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