Value through Innovation27 July 2016

Clinical Study Results

  • BIBT 986 - Renal Insufficiency
    Clinical Study Number 1192.12
    Study Indication Renal Insufficiency
    Product BIBT 986
    Generic Name BIBT 986
    Lab Code
    Clinical Phase I
    Study Title

    Influence of different degrees of renal impairment on the safety,tolerability, pharmacodynamics and pharmacokinetics of 1.0 mg of BIBT 986 BS given as a single dose infusion over 30 minutes in subjects with normal renal function and patients with different degrees of renal impairment in an open, group-comparison design

    Study Document Trial synopsis 1192.12_CO english
  • Deleobuvir - Renal Insufficiency
    Clinical Study Number 1241.32
    Study Indication Renal Insufficiency
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase 1241.32
    Study Title

    Pharmacokinetics, safety and tolerability of the combination of BI 207127 and faldaprevir in patients with different degrees of renal impairment in comparison to subjects with normal renal function in a single center, open-label, parallel-group, phase I trial

    Study Document Trial synopsis 1241.32 english
  • Faldaprevir - Renal Insufficiency
    Clinical Study Number 1220.58
    Study Indication Renal Insufficiency
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, safety and tolerability of BI 201335 in patients with different degrees of renal impairment in comparison to subjects with normal renal function in a monocentric, open-label, parallel-group, phase I trial

    Study Document Trial synopsis 1220.58 english
  • GIOTRIF ® (afatinib) - Renal Insufficiency
    Clinical Study Number 1200.216
    Study Indication Renal Insufficiency
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, safety and tolerability after single dose administration of afatinib in moderate and severe renal impairment in comparison to subjects with normal renal function (a mono-centric, open-label study in matched-group design)

    Study Document Trial synopsis 1200.216 english
  • PRADAXA ® - Renal Insufficiency
    Clinical Study Number 1160.23
    Study Indication Renal Insufficiency
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, pharmacodynamics, safety and tolerability of 150 mg dabigatran etexilate p.o. in patients with different degrees of renal impairment in comparison to subjects with normal renal function in a monocentric, open, parallel-group trial

    Study Document Trial synopsis 1160.23_CO english
  • PRAXBIND ® - Renal Insufficiency
    Clinical Study Number 1321.2
    Study Indication Renal Insufficiency
    Product PRAXBIND ®
    Generic Name Idarucizumab
    Lab Code
    Clinical Phase I
    Study Title

    Randomised, double-blind, placebo-controlled, two-way cross-over Phase Ib study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of BI 655075 and to establish the efficacy of BI 655075 in reversal of dabigatran anticoagulant activity in volunteers

    Study Document Trial synopsis 1321.2 english
  • SPIRIVA ® - Renal Insufficiency
    Clinical Study Number 205.134
    Study Indication Renal Insufficiency
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase I
    Study Title

    The Pharmacokinetics, Safety and Tolerability of Tiotropium (4.8 mcg, single i.v. dose) in Outpatients with Renal Impairment in Comparison to Healthy Subjects (Open Label, Group Comparison, Monocenter Study).

    Study Document Trial synopsis 205.134_CO english
  • TRADJENTA ® - Renal Insufficiency
    Clinical Study Number 1218.26
    Study Indication Renal Insufficiency
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, pharmacodynamics, safety and tolerability of single and multiple 5 mg doses of BI 1356 tablets in patients with different degrees of renal impairment in comparison to subjects with normal renal function in a monocentric, open-label, parallel-group trial

    Study Document Trial synopsis 1218.26_CO english
  • VIRAMUNE ® - Renal Insufficiency
    Clinical Study Number 1100.1259
    Study Indication Renal Insufficiency
    Product VIRAMUNE ®
    Generic Name Nevirapine
    Lab Code
    Clinical Phase I
    Study Title

    An Open-Label, Single-Dose Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine (VIRAMUNE®)

    Study Document Trial synopsis 1100.1259_CO english

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