Effects of the drug Benzbromaron on the pulmonary vessels

Phase 1

• Conditions: Pulmonary arterial hypertension; MedDRA version: 18.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-000709-38-AT
• Lead Sponsor: Medical University of Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-28
• Last Update Posted: 5 September 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified