Long-term extension, multicenter, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg. 1.5 mg, 2 mg. or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH)- CHEST - 2 Study.

Study ID
STU 062010-074

Cancer Related
No

Healthy Volunteers
No

Study Sites

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

Contact
Jacqueline Quivers
214-645-6189
jacqueline.quivers@utsouthwestern.edu

Principal Investigator
Fernando Torres

Summary

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

Study Phases:
and #149; Treatment Phase:
Titration Phase: 8 weeks
Main-Study Phase: Duration until BAY 63-2521 receives official approval and will be commercially available
and #149; Safety Follow Up Phase: 30 days

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

Participant Eligibility

• Patients who have completed 16 weeks of treatment in the double blind trial CHEST-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.