110
Participants
Start Date
December 6, 2023
Primary Completion Date
June 30, 2027
Study Completion Date
June 30, 2027
Generic treprostinil sodium + Standard of Care (Double Oral)
Treprostinil (prostacyclin analogue) solution for continuous subcutaneous (SC) or intravenous (IV) infusion (1 mg/ml; 2.5 mg/ml; 5 mg/ml; 10 mg/ml in 10 mL glass vial) will be administered by an infusion pump system and up-titrated to ≥40 ng/kg/min or to the maximum tolerated dose within 24 weeks. Further up-titration shall be performed until trial completion according to the discretion of the investigator.
Standard of Care - Double Oral
All patients will receive standard of care double oral background treatment consisting of one Phosphodiesterase type 5 inhibitor (i.e., tadalafil or sildenafil) and one Endothelin Receptor Antagonist (i.e. ambrisentan, bosentan or macitentan)
RECRUITING
Ordensklinikum Linz, Linz
RECRUITING
Medical University Vienna, Vienna
NOT_YET_RECRUITING
Fakultní Nemocnice Olomouc, Olomouc
NOT_YET_RECRUITING
Všeobecná fakultní nemocnice v Praze, Prague
NOT_YET_RECRUITING
Hôpital Bicêtre-- Assistance Publique Hopitaux de Paris, Paris
NOT_YET_RECRUITING
Hôpitaux Universitaires de Strasbourg, Strasbourg
NOT_YET_RECRUITING
DRK Kliniken Berlin Westend, Berlin
NOT_YET_RECRUITING
University Hospital Carl Gustav Carus of Technical University Dresden, Dresden
NOT_YET_RECRUITING
Universitätsmedizin Greifswald, Greifswald
NOT_YET_RECRUITING
Gottsegen National Cardiovascular lnstitute, Budapest
NOT_YET_RECRUITING
Medical University of Szeged, Szeged
RECRUITING
Sapienza University of Rome, Rome
NOT_YET_RECRUITING
John Paul II Hospital Krakow, Krakow
NOT_YET_RECRUITING
Fryderyk Chopin Hospital in European Health Centre Otwock, Otwock
NOT_YET_RECRUITING
Centro Hospitalar Lisboa Norte - Santa Maria University Hospital, Lisbon
NOT_YET_RECRUITING
Emergency Institute for Cardiovascular Diseases Prof. Dr. C.C.Iliescu, Bucharest
NOT_YET_RECRUITING
Emergency Clinical County Hospital of Targu Mures, Târgu Mureş
NOT_YET_RECRUITING
Hospital Clinic of Barcelona, Barcelona
NOT_YET_RECRUITING
Hospital Ramon y Cajal, Madrid
Lead Sponsor
Collaborators (2)
ANOVA CRO s.r.o.
UNKNOWN
PharmaLex Belgium
UNKNOWN
Aixial s.r.o.
UNKNOWN
GCP-Service International Ltd. & Co. KG
INDUSTRY
AOP Orphan Pharmaceuticals AG
INDUSTRY