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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT00853112
Eligibility Criteria:
Inclusion Criteria:
* Idiopathic or familial pulmonary arterial hypertension (PAH)
* Mean PAP at least 25 mm Hg, PCWP \< 15 mm Hg at rest
* For females of child-bearing potential negative pregnancy test at screening and use of contraception during the study and 4 weeks after its completion
* Signed and dated informed consent
* Willingness to comply with the study plan and procedures
Exclusion Criteria:
* pulmonary arterial hypertension (PAH)other than idiopathic or familial
* For females, pregnancy or lactation
* Use of specific PAH treatments, potent CYP3A4 inhibitors, protease inhibitors, alpha blockers or arginine 30 days prior tio randomization and during the study
* Change of dose or class of standard background PAH therapy, i.e. oxygen, calcium channel blockers, digoxin, diuretics 30 days prior tio randomization and during the study
* Large shift in altitude (defined as \>5000 feet or 1524 meters) during 90 days prior to baseline visit and/or during the study visit
* Subjects with intracardiac shunts and/or serious heart, lung or other health conditions
* HIV positive subjects
* Subjects participating in another clinical trial with an investigational drug or device
* Subjects with degenerative retinal disorders, history of non-arteritic anterior ischemic optic neuropathy or untreated proliferative diabetic retinopathy
* Allergies and previous intolerance of PDE5 inhibitors
* Alcohol or drug abuse
* Blood donation during the study, or 1 month before or after the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00853112
Study Brief:
Protocol Section:
NCT00853112