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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT02223494
Eligibility Criteria:
Inclusion Criteria:
Patients who
* completed the preceding primary pulmonary hypertension, double-blinded clinical trial of terbogrel (protocol 528.19)
* provide informed consent to participate in this trial
* are in a stable or improving medical condition, in the opinion of the investigator
* enter the study immediately upon their completion of the preceding double-blind Trial 528.19, or enter the study within one month of completing the preceding trial as long as their medical condition has remained stable or continues to improve in the interim
Exclusion Criteria:
* Development of an unstable medical condition during or following completion of the preceding clinical trial which, in the investigator's opinion, may be worsened by treatment with terbogrel
* Premature discontinuation of the preceding terbogrel clinical trial due to an adverse event or for any other reason
* Pregnant or nursing women, or women of childbearing potential (less than one year postmenopausal or not surgically sterilized) who are not using adequate methods of birth control
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02223494
Study Brief:
Protocol Section:
NCT02223494