Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:43 PM
Ignite Modification Date:
2025-12-24 @ 10:43 PM
NCT ID:
NCT01894035
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01894035
Study Brief:
Protocol Section:
NCT01894035