Status:
COMPLETED
Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation
Lead Sponsor:
Bayer
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Brief Summary
This pilot, non-interventional, company-sponsored, multi-center study documents observational data on patients under routine treatment of Pulmonary Arterial Hypertension (PAH) with inhaled iloprost (u...
Eligibility Criteria
Inclusion
- Adult patients (age ≥ 18years old), male or female
- Diagnosis of Pulmonary Arterial Hypertension, Group I of the Dana Point Pulmonary Hypertension classification (Diagnosis made at the discretion of the attending investigator, including mPAP ≥ 25 mmHg at rest, as measured by right heart catheterization.)
- The treating physician has chosen to initiate the treatment with inhaled iloprost with I-Neb device for the application, as described in the Summary of Product characteristics (SmPC).
- WHO/NYHA functional class III
- Willing to participate in the study (Informed Consent Sign)
- Patients who received the first inhaled iloprost treatment with I-Neb from February 1st, 2013.
Exclusion
- Any contraindication for the treatment with Ventavis as described in the Summary of Product characteristics (SmPC)
- Patients are not to be enrolled if they were treated with inhaled iloprost with I-Neb or any other device for the application in the past, before the start of the observation period (February 1st, 2013)
Key Trial Info
Start Date :
September 23 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 13 2017
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01894035
Start Date
September 23 2013
End Date
April 13 2017
Last Update
April 9 2018
Active Locations (1)
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1
Multiple Locations, Portugal