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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT01391104
Eligibility Criteria:
Inclusion Criteria:
* WHO functional class II or III
* Idiopathic PAH, familial PAH, or associated PAH due to connective tissue disease patients
* Mean pulmonary artery pressure ≥25 mmHg at rest
* Pulmonary capillary wedge pressure ≤15 mmHg
Exclusion Criteria:
* Prior use of phosphodiesterase type-5 inhibitors
* Unstable clinical condition over the last 4 months
* Recent syncope
* WHO functional class IV
* Left ventricular ejection fraction \<40%
* Restrictive or obstructive lung disease
* Intrinsic musculoskeletal abnormality precluding exercise testing
* Patients with a pacemaker
* Treatment with systemic corticosteroids
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01391104
Study Brief:
Protocol Section:
NCT01391104