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