Einstein Junior Phase III: Paediatric oral rivaroxaban (BAY 59-7939)

• Research type

  Research Study

• Full title

  Multicenter, open-label, active-controlled, randomized study to evaluate the efficacy and safety of an age-and body weight-adjusted rivaroxaban regimen compared to standard of care in children with acute venous thromboembolism.

• IRAS ID

  155345

• Contact name

  Tina Biss

• Contact email

  Tina.biss@nuth.nhs.uk

• Sponsor organisation

  Bayer HealthCare Pharmaceuticals Inc

• Eudract number

  2014-000565-47

• Research summary

  The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  14/NE/1050

• Date of REC Opinion

  17 Sep 2014

• REC opinion

  Further Information Favourable Opinion