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PATENT-2: Long-Term Extension of PATENT-1 Trial

  • Research type

    Research Study

  • Full title

    Long-term extension, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1mg, 1.5mg, 2mg or 2.5mg TID) in patients with symptomatic Pulmonary Arterial Hypertension (PAH).

  • IRAS ID

    10719

  • Contact name

    Joanna Pepke-Zaba

  • Contact email

    joanna.pepkezaba@papworth.nhs.uk

  • Sponsor organisation

    Bayer Public Limited Company

  • Eudract number

    2008-003610-94

  • ISRCTN Number

    n.a

  • Clinicaltrials.gov Identifier

    n.a

  • Research summary

    Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934) will be asked to participate in this long term extension study with BAY63-2521.Key Inclusion Criteria:
    Patients who have completed 12 weeks of treatment in the double blind trial PATENT 1
    Key Exclusion Criteria:
    Patients who have an ongoing serious adverse event from PATENT 1 that is assessed as related to BAY63-2521 are not allowed to participate in the extension trial.

  • REC name

    East of England - Cambridge East Research Ethics Committee

  • REC reference

    09/H0304/8

  • Date of REC Opinion

    20 Apr 2009

  • REC opinion

    Further Information Favourable Opinion