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