Overview

Ventavis® Registry Protocol

Status:
Terminated
Trial end date:
2014-02-01
Target enrollment:
0
Participant gender:
All
Summary
The Ventavis® (iloprost) Registry is a multicenter, observational, U.S.-based study that longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I PAH who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2 years from the time of enrollment. Data will be collected via patient interview and review of the medical record. Quarterly data collection will include capture of medications and Ventavis® adherence data.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Actelion
Treatments:
Iloprost
Criteria
Inclusion Criteria:

1. Have a current diagnosis of WHO Group I PAH

2. Have initiated therapy with commercial Ventavis® administered via portable nebulizer
at least 3 months prior to study enrollment, either with commercial product or from
participation in Actelion's Clinical Study AC-063A302

3. Age > or = 18 years old at the time of enrollment

Exclusion Criteria:

1. Meet the criteria for inclusion into WHO Groups II, III, IV or V PAH

2. Are not currently on commercial Ventavis®

3. Have initiated therapy with commercial Ventavis® administered via portable nebulizer
less than 3 months prior to study enrollment