Acute Effects of Benzbromaron on the Pulmonary Circulation

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2017
• Main ID: NCT02790450
• Date of registration: 30/05/2016
• Prospective Registration: No
• Primary sponsor: Medical University of Graz
• Public title: Acute Effects of Benzbromaron on the Pulmonary Circulation
• Scientific title: Acute Effects of Benzbromaron on the Pulmonary Circulation
• Date of first enrolment: October 2015
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02790450
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Austria

Contacts

• Name: Horst Olschewski, MD
• Affiliation: Medical University of Graz

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Arterial Hypertension

Intervention(s)

Drug: Benzbromarone

Primary Outcome(s)

Pulmonary vascular resistance (Wood units) assessed by right heart catheterization [Time Frame: 2 hours]

Secondary Outcome(s)

Mean systemic arterial pressure (mmHg) assessed by sphygmomanometer [Time Frame: 2 hours]

arterial oxygen saturation 8%) assessed by arterial blood gas analysis [Time Frame: 2 hours]

Mean pulmonary arterial pressure (mmHg) assessed by right heart catheterization [Time Frame: 2 hours]

Secondary ID(s)

27-253 ex 14/15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ludwig Boltzmann Institute for Lung Vascular Research