PATENT-2: Long-Term Extension of PATENT-1 Trial
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).
Bayer Public Limited Company
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.
East of England - Cambridge East Research Ethics Committee
Date of REC Opinion
20 Apr 2009
Further Information Favourable Opinion