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

Study ID
Study00002366

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern University Hospital—St. Paul
  • UT Southwestern University Hospital—St. Paul

Contact
Jacqueline Quivers
214-645-6489
jacqueline.quivers@utsouthwestern.edu

Principal Investigator
Fernando Torres

Summary

This is a Multicenter, multinational, open label one arm study in patients with symptomatic PAH.

Study Phases:

* Treatment Phase
¬Tiration Phase: 8 weeks
¬Main-Study Phase: Duration until BAY 63-2521 receives official approval and will be commercially available

* Safety Follow Up Phase: 30 days (only for patients who do not enter the open label extension trial or who stop the study medication prematurely)

BAY 63-2521 will be administered orally as a film-coated tablet in doses of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg t.i.d.

Participant Eligibility

Inclusion Criteria

* Patients who have completed 12 weeks of treatment in the double blind trial PATENT 1.

* Patients must have given their written informed consent to participate in the study after having received adequate previous information and prior to any study-specific procedures.