Clinical Trials Logo

Clinical Trial Summary

To observe and assess drug administration activities, time spent on drug administration activities, and patient-reported outcomes (PROs) including quality of life, treatment satisfaction, and patient perception of devices related to use of United Therapeutics Corporation (UTC)-developed next-generation infusion pumps to administer Remodulin in patients with Pulmonary Arterial Hypertension (PAH).


Clinical Trial Description

This is a virtual, patient-centric, observational study that will follow approximately 60 participants for up to 8 weeks following initiation of Remodulin therapy via their UTC-developed next generation infusion pump and consists of remote and electronic assessments administered to patient via the uMotif® data capture platform at Study Enrollment, Day 1 (or Combined Study Enrollment/Day 1, if applicable), Week 2, Week 4, and Week 8 or Early Withdrawal (if applicable). The study population will consist of 2 cohorts of PAH patients: 1. De Novo Cohort: patients new to parenteral prostacyclin-class therapy. 2. Transition Cohort: patients who are currently receiving SC Remodulin therapy via a previous generation infusion pump. The De Novo Cohort will initiate subcutaneous (SC) Remodulin via a next generation infusion pump as prescribed by their healthcare professional. Participants will be followed from time of enrollment to up to 8 weeks after Day 1 (ie, start of infusion of Remodulin via a next generation infusion pump) or until discontinuation of Remodulin (early withdrawal), whichever comes first. The Transition Cohort will continue to receive Remodulin as prescribed by their healthcare professional via their current (ie, previous generation) infusion pump until transitioning to delivery of Remodulin via a next generation infusion pump. Participants will be followed from time of enrollment to up to 8 weeks after Day 1 (ie, first day patient transitions to delivery of Remodulin via a next generation infusion pump) or until discontinuation of Remodulin (early withdrawal), whichever comes first. Following the completion of study assessments at Week 8 or Early Withdrawal (if applicable), participants will continue Remodulin therapy via their infusion pump at their prescriber's discretion. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05060315
Study type Observational
Source United Therapeutics
Contact Kevin Maher
Phone (919) 425-8139
Email [email protected]
Status Not yet recruiting
Phase
Start date October 31, 2021
Completion date November 30, 2022

See also
  Status Clinical Trial Phase
Completed NCT04076241 - Effects of Adding Yoga Respiratory Training to Osteopathic Manipulative Treatment in Pulmonary Arterial Hypertension N/A
Recruiting NCT04930289 - Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs
Enrolling by invitation NCT04908397 - Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension Phase 1
Recruiting NCT03288025 - Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE) N/A
Recruiting NCT04266197 - Effects of RT234 on Exercise Parameters Accessed by CPET in Subjects With PAH Phase 2
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Completed NCT02060487 - Effects of Oral Sildenafil on Mortality in Adults With PAH Phase 4
Recruiting NCT03497689 - EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial Hypertension Phase 4
Not yet recruiting NCT04254289 - Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension N/A
Terminated NCT02253394 - The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study Phase 4
Withdrawn NCT02958358 - FDG Uptake and Lung Blood Flow in PAH Before and After Treatment With Ambrisentan N/A
Terminated NCT01953965 - Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI. Phase 2
Withdrawn NCT01723371 - Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children Phase 1/Phase 2
Unknown status NCT01712997 - Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients Phase 3
Not yet recruiting NCT01649739 - Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost Phase 4
Completed NCT01548950 - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension N/A
Completed NCT01165047 - Nitric Oxide, GeNO Nitrosyl Delivery System Phase 2
Completed NCT00942708 - Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension Phase 2
Completed NCT00963027 - Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil Phase 1
Completed NCT00963001 - Effect of Food on the Pharmacokinetics of Oral Treprostinil Phase 1