Effects of the drug Benzbromaron on the pulmonary vessels

Acute Effects of Benzbromaron on the pulmonary circulation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000709-38-AT

Enrollment

Unknown

Registered

2015-07-28

Start date

2015-10-20

Completion date

Unknown

Last updated

2016-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary arterial hypertension MedDRA version: 18.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Benzbromaron AL Product Name: Benzbromaron Pharmaceutical Form: Film-coated tablet INN or Proposed INN: BENZBROMARONE CAS Number: 3562-84-3 Concentration unit: mg milligram(s) Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: informed consent diagnosis of pulmonary arterial hypertension age: 18-90 years Medically indicated right heart catheterization Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: known allergy against benzbromaron, gelborange S or another component of the drug or against a drug with similar chemical structure decreased renal function (GFR1.6 mg% or AST or ALT > 3x ULN) known pregnancy uncontrolled systemic arterial hypertension (at rest >150 mmHg systolic or 95 mmHg diastolic) uncontrolled ventricular arrythmias uncontrolled bradycard or tachycard supraventricular arrythmias myicardial infarction in the last 12 months acute pulmonary embolism in the last 6 months ongoing iv or sc Prostanoidtherapy for pulmonary arterial hypertension

Design outcomes

Primary

Measure	Time frame
Main Objective: to assess the change of pulmonary vascular resistance 2 hours after the application of 200mg benzbromaron;Secondary Objective: to assess the change of mean pulmonary arterial pressure, systemic blood pressure and oxygen saturation 2 hours after the application of 200mg benzbromaron;Primary end point(s): change in pulmonary vascular resistance;Timepoint(s) of evaluation of this end point: before the application of benzbromaron and two hours after benzbromaron	—

Measure

Time frame

Main Objective: to assess the change of pulmonary vascular resistance 2 hours after the application of 200mg benzbromaron;Secondary Objective: to assess the change of mean pulmonary arterial pressure, systemic blood pressure and oxygen saturation 2 hours after the application of 200mg benzbromaron;Primary end point(s): change in pulmonary vascular resistance;Timepoint(s) of evaluation of this end point: before the application of benzbromaron and two hours after benzbromaron

—

Secondary

Measure	Time frame
Secondary end point(s): mean pulmonary arterial pressure, systemic blood pressure and oxygen saturation ;Timepoint(s) of evaluation of this end point: before the application of benzbromaron and two hours after benzbromaron	—

Countries

Austria

Contacts

Public ContactDepartment for Pulmonology

Medical University of Graz

gabor.kovacs@klinikum-graz.at4331638512183

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026