Ventavis® Registry Protocol

• Register: ClinicalTrials.gov
• Last refreshed on: 20 April 2015
• Main ID: NCT00902603
• Date of registration: 13/05/2009
• Prospective Registration: No
• Primary sponsor: Actelion
• Public title: Ventavis® Registry Protocol RESPIRE
• Scientific title: Registry to Prospectively Evaluate Use of Ventavis® in Patients With Pulmonary Arterial Hypertension
• Date of first enrolment: March 2009
• Target sample size: 148
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00902603
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 19 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Commercial Ventavis® (iloprost)

Primary Outcome(s)

Adherence with instructions for use of Ventavis® [Time Frame: 2 years]

Secondary Outcome(s)

Persistence of use of Ventavis® [Time Frame: 2 years]

Secondary ID(s)

AC-063A501

Source(s) of Monetary Support

Please refer to primary and secondary sponsors