The primary objective of this study is to assess the effect of early and rapid treprostinil
therapy for mean pulmonary artery pressure (mPAP) reduction to improve right ventricular (RV)
function and reverse RV remodeling in participants with pulmonary arterial hypertension
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Participants will receive parenteral treprostinil at an initial dose of 1.25 nanograms (ng)/kilogram (kg)/minute (min) (or 0.625 ng/kg/min, if initial dose is not tolerated) either intravenously (IV) or subcutaneously (SC).
Based on Month 6 mPAP assessment or earlier at Investigator's discretion and after a target dose is reached, participants may transition to oral treprostinil 3 times daily (TID) and continue up-titration in dose towards further reduction of mPAP or participants may continue up-titration of parenteral treprostinil until Month 12. Following completion of all Month 12 assessments, at Investigator's discretion, participants may transition from parenteral to oral treprostinil TID and continue up-titration for further reduction of mPAP. Treprostinil therapy (parenteral or oral) may continue, as tolerated, towards the goal of further reduction of mPAP until Month 36.
Drug: - Parenteral Treprostinil
Parenteral treprostinil will be administered per schedule specified in the arm description.
Drug: - Oral Treprostinil
Oral treprostinil will be administered per schedule specified in the arm description.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Henry Ford Health System
Detroit, Michigan, 48202
University of Nebraska Medical Center
Omaha, Nebraska, 68198