Value through Innovation27 July 2016

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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
  • PRADAXA ® - Venous Thromboembolism
    Clinical Study Number 1160.248
    Study Indication Venous Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase III
    Study Title

    RE-SPECT CVT: a randomised, open-label, exploratory trial with blinded endpoint adjudication (PROBE), comparing efficacy and safety of oral dabigatran etexilate versus oral warfarin in patients with cerebral venous and dural sinus thrombosis over a 24-week period

    Study Document
    Trial synopsis 1160.248 english
    Lay summary 1160.248 english
    Lay summary 1160.248 dutch
    Lay summary 1160.248 french
    Lay summary 1160.248 german
    Lay summary 1160.248 italian
    Lay summary 1160.248 polish
    Lay summary 1160.248 portuguese
    Lay summary 1160.248 spanish
  • PRADAXA ® - Venous Thromboembolism
    Clinical Study Number 1160.188
    Study Indication Venous Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IV
    Study Title

    ChaRactErization of patients following aCute venous thrOmboembolism (VTE) and assessment of safety and effectiveness of dabigatran etexilate (DE) in the tReatment and secondarY prevention of acute deep vein thrombosis (DVT) and pulmonary embolism (PE) in comparison to vitamin K antagonist (VKA) in routine clinical practice - RE-COVERY DVT/PE

    Study Document
    Trial synopsis 1160.188 english
  • PRADAXA ® - Venous Thromboembolism
    Clinical Study Number 1160.106
    Study Indication Venous Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase IIb/III
    Study Title

    Open-label, randomized, parallel-group, active-controlled, multi-centre, non-inferiority study of dabigatran etexilate versus standard of care for venous thromboembolism treatment in children from birth to less than 18 years of age: The DIVERSITY study

    Study Document
    Trial synopsis 1160.106 english
  • PRADAXA ® - Venous Thromboembolism
    Clinical Study Number 1160.108
    Study Indication Venous Thromboembolism
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase III
    Study Title

    Open label, single arm safety prospective cohort study of dabigatran etexilate for secondary prevention of venous thromboembolism in children from 0 to less than 18 years

    Study Document
    Trial synopsis 1160.108 english