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

  • Research type

    Research Study

  • Full title

    Long-term extension, multi-centre, 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 Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

  • IRAS ID

    10595

  • Sponsor organisation

    Bayer Healthcare AG

  • Eudract number

    2008-003539-19

  • ISRCTN Number

    n.a

  • Clinicaltrials.gov Identifier

    n.a

  • Research summary

    Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.Key Inclusion Criteria: - Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1Key Exclusion Criteria:- Patients who have an ongoing serious adverse event from CHEST 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/H0304/9

  • Date of REC Opinion

    20 Apr 2009

  • REC opinion

    Further Information Favourable Opinion