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 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT00319020
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent by the parents or the legal representatives.
* Patients who completed the FUTURE 1 study.
* Patients who tolerated bosentan pediatric formulation and for whom bosentan is considered beneficial at the end of FUTURE 1.
* Males or females \>= 2 and \< 12 years of age at enrollment in FUTURE 2 (this study). Females who are menstruating must have a negative pregnancy test. A reliable method of contraception must be considered, if appropriate.
Exclusion Criteria:
* Intolerance to bosentan despite dose reductions.
* Any clinically significant laboratory abnormality that precludes continuation of bosentan therapy.
* Pregnancy or breast-feeding.
* Known hypersensitivity to bosentan or any of the excipients.
* Premature and permanent study drug discontinuation during FUTURE 1.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
11 Years
Study:
NCT00319020
Study Brief:
Protocol Section:
NCT00319020