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

NCT01780987

Last updated date
Study Location
Aichi Medical University Hospital
Nagakute, Aichi, 480-1195, Japan
Contact
1-800-718-1021

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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

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Deep Vein Thrombosis, Pulmonary EmbolismAStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients
NCT01780987
  1. Nagakute, Aichi
  2. Sakura, Chiba
  3. Kitakyusyu, Fukuoka
  4. Hatsukaichi, Hiroshima
  5. Sapporo, Hokkaido
  6. Kahoku-gun, Ishikawa
  7. Yokohama, Kanagawa
  8. Yokohama, Kanagawa
  9. Tsu, MIE
  10. Okayama City, Okayama
  11. Osakasayama, Osaka
  12. Suita-shi, Osaka
  13. Chuo-ku, Tokyo
  14. Itabashi-ku, Tokyo
  15. Meguro-ku, Tokyo
  16. Musashino, Tokyo
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  19. Kumamoto,
  20. Kumamoto,
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Advanced Information
Descriptive Information
Brief Title  ICMJE AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients
Official Title  ICMJE 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
Brief 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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Deep Vein Thrombosis
  • Pulmonary Embolism
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Apixaban
    Intervention: Drug: Apixaban
  • Active Comparator: UFH/Warfarin
    Interventions:
    • Drug: Unfractionated Heparin (UFH)
    • Drug: Warfarin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2013)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01780987
Other Study ID Numbers  ICMJE B0661024
CV185160 ( Other Identifier: BMS )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2016

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