Effects of the drug Benzbromaron on the pulmonary vessels

• Register: EUCTR
• Last refreshed on: 5 September 2016
• Main ID: EUCTR2015-000709-38-AT
• Date of registration: 28/07/2015
• Prospective Registration: Yes
• Primary sponsor: Medical University of Graz
• Public title: Effects of the drug Benzbromaron on the pulmonary vessels
• Scientific title: Acute Effects of Benzbromaron on the pulmonary circulation
• Date of first enrolment: 20/10/2015
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000709-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria

Contacts

• Name: Department for Pulmonology
• Affiliation: Medical University of Graz

• Name: Department for Pulmonology
• Affiliation: Medical University of Graz

Key inclusion & exclusion 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:
known allergy against benzbromaron, gelborange S or another component of the drug or against a drug with similar chemical structure
decreased renal function (GFR<60ml/min/kg)
renal diathesis
severe lilver disease (Bilirubin >1.6 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

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)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: before the application of benzbromaron and two hours after benzbromaron

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

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: before the application of benzbromaron and two hours after benzbromaron

Secondary end point(s): mean pulmonary arterial pressure, systemic blood pressure and oxygen saturation

Secondary ID(s)

BBR

Source(s) of Monetary Support

Ludwig Boltzmann Institute for Lung Vascular Research

Medical University of Graz