Status:
COMPLETED
Observation of Patients With Primary Pulmonary Hypertension Receiving Prescribed Ventavis Inhalation Therapy Regarding Safety and Efficacy for up to 4 Years
Lead Sponsor:
Bayer
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
18+ years
Brief Summary
This is an observational study to monitor the continued effectiveness of Ventavis (inhaled iloprost) in the long-term. The study observes the effects and the safety of Ventavis inhalation therapy over...
Eligibility Criteria
Inclusion
- The treating physician has chosen Ventavis as a suitable long-term treatment for the patient
- Patient with primary pulmonary hypertension (i.e. Idiopathic Pulmonary Arterial Hypertension or Familial Pulmonary Arterial Hypertension) and classified as NYHA functional class III (NYHA = New York Heart Association)
- No prior treatment with Ventavis or other active treatments for primary pulmonary hypertension within 6 weeks of date of study inclusion (unless otherwise advised by Bayer Schering Pharma)
Exclusion
- Any condition that prevents participation in the study, including pregnancy and other contraindications for Ventavis treatment (as listed in the current Ventavis Summary of Product Characteristics and patient package insert)
Key Trial Info
Start Date :
April 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00250640
Start Date
April 1 2005
End Date
July 1 2012
Last Update
February 2 2015
Active Locations (43)
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1
Brest, France, F-29609
2
Clamart, France, 92141
3
Lille, France, 59037
4
Lyon, France, 69394