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:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2025-12-25 @ 3:17 AM
NCT ID:
NCT01588405
Eligibility Criteria:
Inclusion Criteria:
* Between 15 and 80 years of age, inclusive, weigh at least 40 kg and have a diagnosis of PAH
* Have stable disease as confirmed by recent right heart catheterization and a Baseline 6MWD of at least 250 meters
* Have been receiving Remodulin for at least 90 days and at a stable dose for at least 30 days prior to the Baseline visit; the dose of Remodulin must be between 25-75 ng/kg/min, inclusive
* Must be also receiving an endothelin receptor antagonist (ERA) and/or a phosphodiesterase-5 inhibitor (PDE-5i) for at least 90 days and have been at a stable dose for at least 30 days prior to Baseline
Exclusion Criteria:
* WHO functional class III and IV subjects will be excluded
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
80 Years
Study:
NCT01588405
Study Brief:
Protocol Section:
NCT01588405