Value through Innovation27 July 2016

Clinical Study Results

  • PRADAXA ® - Venous Thromboembolism
    Clinical Study Number 1160.63
    Study Indication Venous Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase III
    Study Title

    Twice-daily oral direct thrombin inhibitor dabigatran etexilate in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism RESONATE

    Study Document Trial synopsis 1160.63_DR english
  • PRADAXA ® - Venous Thromboembolism
    Clinical Study Number 1160.64
    Study Indication Venous Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase III
    Study Title

    A phase III randomised, parallel group, double-blind, active controlled study to investigate the efficacy and safety of orally administered 220 mg dabigatran etexilate capsules (110 mg administered on the day of surgery followed by 220 mg once daily) compared to subcutaneous 40 mg enoxaparin once daily for 28-35 days in prevention of venous thromboembolism in patients following primary elective total hip arthroplasty (RE-NOVATE II)

    Study Document Trial synopsis 1160.64_DR english
  • PRADAXA ® - Venous Thromboembolism
    Clinical Study Number 1160.88
    Study Indication Venous Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IIa
    Study Title

    Open-label safety and tolerability study of dabigatran etexilate given for 3 days at the end of standard anticoagulant therapy in children aged 12 years to less than 18 years

    Study Document Trial synopsis 1160.88_DS_CO english
  • PRADAXA ® - Venous Thromboembolism
    Clinical Study Number 1160.11
    Study Indication Venous Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IIa
    Study Title

    Multicenter, open-label, ascending dose study of BIBR 1048 in the prevention of venous thromboembolism in patients undergoing primary elective total hip replacement surgery. Bistro I (Boehringer Ingelheim Study in ThROmbosis).

    Study Document Trial synopsis 1160.11 english
  • PRADAXA ® - Venous Thromboembolism
    Clinical Study Number 1160.30
    Study Indication Venous Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IIa
    Study Title

    Multicenter, open-label, ascending dose study of BIBR 1048 in prevention of venous thromboembolism in patients undergoing primary elective total hip replacement surgery

    Study Document Trial synopsis 1160.30 english
  • PRADAXA ® - Venous Thromboembolism
    Clinical Study Number 1160.105
    Study Indication Venous Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IIa
    Study Title

    Open-label, single dose, tolerability, Pharmacokinetic/Pharmacodynamics and safety study of dabigatran etexilate given at the end of standard anticoagulant therapy in children aged less than 1 year old

    Study Document Trial synopsis 1160.105_DR english
  • PRADAXA ® - Venous Thromboembolism
    Clinical Study Number 1160.89
    Study Indication Venous Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IIa
    Study Title

    Single dose open-label PK/PD, safety and tolerability study of dabigatran etexilate mesilate given at the end of standard anticoagulant therapy in successive groups of children aged 2 years to less than 12 years followed by 1 year to less than 2 years

    Study Document Trial synopsis 1160.89_CO english
  • PRADAXA ® - Venous Thromboembolism
    Clinical Study Number 1160.102
    Study Indication Venous Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    Cohort study in prevention of venous thromboembolic events after orthopaedic surgery in patients treated with Pradaxa®

    Study Document Trial synopsis 1160.102 english

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