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 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT00423592
Eligibility Criteria:
Summary of Inclusion Criteria:
* Males and Females between 12 and 75 years of age
* Current diagnosis of IPAH, FPAH, or PAH associated with collagen vascular disease, congenital systemic-to-pulmonary shunts, anorexigen use, HIV infection
* Must have previously discontinued bosentan or sitaxsentan therapy due to serum aminotransferase (ALT and/or AST) concentrations \> 3 x ULN
* Must have normal (\< 1 x ULN) serum ALT and AST concentrations at screening
* Six-minute Walk distance of at least 150 meters at screening
* If receiving sildenafil or a clinically approved prostanoid for PAH, must have been on stable therapy for at least 4 weeks prior to screening
* Subjects with a diagnosis of HIV must have stable disease status during the screening period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
75 Years
Study:
NCT00423592
Study Brief:
Protocol Section:
NCT00423592