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 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT01469169
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects aged 18 to 75 years
* Symptomatic Pulmonary Artery Hypertension (PAH) classified (Dana Point Classification 1)
* New York Heart Association (NYHA)/World Health Organization (WHO) functional class III or IV
* PAPmean at rest \> 25 mm Hg, Pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure \</= 15 mm Hg and Pulmonary Vascular resistance (PVR) \>/= 240 dyn.sec.cm-5 (\>/= 400 dyn.sec.cm-5 for patients treated with both endothelin receptor antagonist (ERA) and phosphodiesterase-5 inhibitor (PDE5i) ) as measured by Right Heart Catheter test
* Women of childbearing potential and men must agree to use adequate contraception when sexually active
Exclusion Criteria:
* Baseline 6-minute walk distance of less than 100 meters or more than 500 meters
* Subjects with critical severe PAH
* Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio \< 60% and/or Total Lung Capacity (TLC) \< 70% predicted (especially at interstitial lung disease, TLC \< 60% predicted)
* Clinically relevant obstructive lung disease (e.g. asthma or chronic obstructive pulmonary disease )
* More than mild patchy interstitial lung disease on High Resolution Computerized Tomography (HRCT)
* History of left-sided heart disease
* Uncontrolled systemic hypertension as evidenced by systolic blood pressure \>/= 160 mm Hg or diastolic blood pressure \>/= 100 mm Hg on repeated measurement
* Systemic hypotension with systolic blood pressure \< 85 mm Hg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01469169
Study Brief:
Protocol Section:
NCT01469169