E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pulmonary arterial hypertension |
Pulmonal arterielle Hypertonie |
|
E.1.1.1 | Medical condition in easily understood language |
elevated pulmonary blood pressure |
Lungenhochdruck |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10064911 |
E.1.2 | Term | Pulmonary arterial hypertension |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
|
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to assess the change of pulmonary vascular resistance 2 hours after the application of 200mg benzbromaron |
Messung der Änderung des pulmonalen Gefäßwiderstandes 2 Stunden nach der einmaligen Gabe von Benzbromaron 200mg per os |
|
E.2.2 | Secondary objectives of the trial |
to assess the change of mean pulmonary arterial pressure, systemic blood pressure and oxygen saturation 2 hours after the application of 200mg benzbromaron |
Messung der Änderung des mittleren pulmonalen Drucks, des systemischen Drucks sowie der Oxygenierung nach der einmaligen Gabe von Benzbromaron 200mg per os |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
informed consent diagnosis of pulmonary arterial hypertension age: 18-90 years Medically indicated right heart catheterization |
• Schriftliche Einwilligung • PatientInnen mit gesicherter pulmonal arterieller Hypertonie • Alter: 18 – 90 Jahre • Medizinisch indizierte Rechtsherzkatheter Untersuchung
|
|
E.4 | Principal 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 |
• Überempfindlichkeit gegenüber Benzbromaron, Gelborange S oder einem der sonstigen Bestandteile oder gegenüber Medikamenten mit ähnlicher chemischer Struktur • eingeschränkte Nierenfunktion (GFR<60ml/min/kg) • Nierensteindiathese. • vorbestehende schwere Lebererkrankungen (Bilirubin >1.6 mg% oder AST oder ALT > 3x über Norm) • Schwangerschaft (anamnestisch erhoben) • Unkontrollierte systemisch arterielle Hypertonie (Ruhe >150 mmHg systolisch oder 95 mmHg diastolisch) • Unkontrollierte ventrikuläre Herzrhythmusstörungen • Unkontrollierte bradykarde oder tachykarde supraventrikuläre Rhythmusstörungen • Myokardinfarkt in den letzten 12 Monaten • Lungenarterienembolie in den letzten 6 Monaten • laufende iv. oder sc. Prostanoidtherapie für die PAH
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E.5 End points |
E.5.1 | Primary end point(s) |
change in pulmonary vascular resistance |
Pulmonale Gefäßwiderstandsänderung |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
before the application of benzbromaron and two hours after benzbromaron |
vor und 2 Stunden nach Benzbromarongabe |
|
E.5.2 | Secondary end point(s) |
mean pulmonary arterial pressure, systemic blood pressure and oxygen saturation |
mittlerer pulmonaler Druck, systemischer Druck, Oxygenierung |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
before the application of benzbromaron and two hours after benzbromaron |
vor und 2 Stunden nach Benzbromarongabe |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Letzter Besuch des letzten Teilnehmers |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |