NCT05699486 - A Study to Evaluate the Efficacy, Safety and Tolerability of PDNO Infusion in Patients With Pulmonary Hypertension After Cardiopulmonary Bypass Surgery | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 23, 2022

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2023

Conditions

Pulmonary Hypertension

Interventions

DRUG

PDNO

PDNO consists of propylene glycol (1,2-propanediol, PD) chemically combined with NO (to be donated). The drug substance is formulated as an inherent mixture of 4 structure analogues. The mixture consists of an equilibrium of the 2 regioisomers 1-(nitrosooxy) propan-2-ol and 2-(nitrosooxy) propan-1-ol. In addition, each regioisomer is a racemic mixture.

DRUG

Sodium chloride (placebo)

Placebo (NaCl, commercially available dilution solution for parenteral use, 9 mg/mL)

Trial Locations (2)

SE-413 45

RECRUITING

Sahlgrenska University Hospital, Anaesthesiology and Intensive Care, Gothenburg

SE-701 85

RECRUITING

Örebro University Hospital, Vascular and Thoracic Department (Kärl-Thoraxkliniken), Örebro