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 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
NCT ID:
NCT02790450
Eligibility Criteria:
Inclusion Criteria:
* written informed consent
* known pulmonary arterial hypertension
* right heart catheterization indicated due to clinical reasons
Exclusion Criteria:
* known allergy against Benzbromaron, Gelborange S or other ingredient of the used drug (Benzbromarone AL) or a drug with similar chemical structure
* severe renal insufficiency (GFR\<30ml/min/kg)
* renal diathesis
* severe hepatic disease (Bilirubin \>1.6 mg% or AST or ALT \> 3x Norm)
* known pregnancy
* uncontrolled systemic arterial hypertension (\>150 mmHg systolic or 95 mmHg diastolic)
* uncontrolled ventricular arrythmia
* uncontrolled bradycardic or tachycardic supraventricular arrythmia
* myocardiac infarction within the last 12 months
* pulmonary embolism within the last 6 months
* ongoing iv. or sc. Prostanoid therapy for PAH
* Pulmonary hypertension other than PAH
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT02790450
Study Brief:
Protocol Section:
NCT02790450