United Therapeutics: Pulmonary Arterial Hypertension trials

The registry lists 52 Pulmonary Arterial Hypertension studies with United Therapeutics as lead sponsor. 1 are open to participants now and 29 have results posted.

Phase 1 8Phase 2 9Phase 3 18Phase 4 11No phase 6(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label ExtensionEnrolling by invitationNCT03683186Phase 3
• Study of Ralinepag on Exercise Capacity by Cardiopulmonary Exercise Testing (CPET) in WHO Group 1 PH SubjectsTerminatedNCT04084678Phase 3Results posted
• Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using TyvasoCompletedNCT03950739Phase 1Results posted
• Patient Global Impression Questions for Activity-Induced Symptoms in Participants With PAHCompletedNCT03888365Results posted
• A Study With BPS-314d-MR-PAH-303 in Participants With Pulmonary Arterial HypertensionTerminatedNCT03657095Phase 3Results posted
• EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial HypertensionCompletedNCT03497689Phase 4Results posted
• TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)CompletedNCT03055221Phase 4Results posted
• Safety and Tolerability of Rapid Dose Titration of Subcutaneous Remodulin® Therapy in PAH Subjects (RAPID)CompletedNCT02847260Phase 4Results posted
• Long-term Safety and Efficacy of Ralinepag in Pulmonary Arterial HypertensionCompletedNCT02279745Phase 2Results posted
• Safety and Efficacy of APD811 in Pulmonary Arterial HypertensionCompletedNCT02279160Phase 2Results posted
• A Pharmacokinetic Substudy of the TDE-PH-304 ProtocolCompletedNCT01934582Phase 3Results posted
• Beraprost-314d Added-on to Tyvaso® (BEAT)CompletedNCT01908699Phase 3Results posted
• Remodulin® to Oral Treprostinil TransitionCompletedNCT01588405Phase 2Results posted
• An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial HypertensionCompletedNCT01560637Phase 3Results posted
• Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral MonotherapyCompletedNCT01560624Phase 3Results posted
• Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®CompletedNCT01477333Phase 2Results posted
• Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH TherapiesCompletedNCT01266265Results posted
• A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary HypertensionCompletedNCT01028651Results posted
• An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial HypertensionCompletedNCT01027949Phase 3Results posted
• Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) PatientsCompletedNCT00990314Phase 2Results posted
• Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH)CompletedNCT00989963Phase 2Results posted
• Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial HypertensionCompletedNCT00887978Phase 3Results posted
• An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) PatientsCompletedNCT00792571Phase 2Results posted
• A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH PatientsCompletedNCT00781885Phase 2Results posted
• Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) SubjectsCompletedNCT00741819Phase 4Results posted
• Rapid Switch From Flolan to Remodulin in the Outpatient ClinicTerminatedNCT00643604Phase 4Results posted
• Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAHTerminatedNCT00439946Phase 4Results posted
• FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)CompletedNCT00325442Phase 3Results posted
• FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)CompletedNCT00325403Phase 3Results posted
• Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)CompletedNCT00147199Phase 3Results posted
• A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Participants With Pulmonary Arterial HypertensionActive, not recruitingNCT05203510Phase 4
• Evaluate Real-World Use of Next Generation Infusion Pumps to Administer RemodulinTerminatedNCT05060315
• A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH PatientsCompletedNCT03626688Phase 3
• ADAPT - A Patient Registry of the Real-world Use of Orenitram®Active, not recruitingNCT03045029
• Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Adult PAHWithdrawnNCT03016468Phase 2
• Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial HypertensionWithdrawnNCT02999906Phase 3
• Safety, Tolerability, Pharmacokinetics and Efficacy of Two Different Rates of Subcutanous Remodulin® Dose Titration in Pulmonary Arterial HypertensionWithdrawnNCT02893995Phase 4
• An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial HypertensionWithdrawnNCT02882126Phase 4
• Tyvaso Dosing and Titration Evaluation: TyTRATE RegistryCompletedNCT01799473
• Safety Study of PLX-PAD Cells to Treat Pulmonary Arterial Hypertension (PAH)TerminatedNCT01795950Phase 1
• Inhaled Treprostinil for PAH: Open-label ExtensionWithdrawnNCT01557660Phase 3
• Safety and Efficacy of Inhaled Treprostinil in Patients With PAHWithdrawnNCT01557647Phase 3
• A Multinational, Multicenter, Study to Assess the Efficacy and Safety of BPS-314d-MR in Subjects With Pulmonary Arterial Hypertension Currently Receiving Treatment With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 InhibitorWithdrawnNCT01458236Phase 3
• A Bioavailability Study Comparing Treprostinil Diethanolamine Oral Tablets and Oral Solution in Healthy VolunteersCompletedNCT01172496Phase 1
• Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent FacilitiesCompletedNCT01165476Phase 1
• Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil DiethanolamineCompletedNCT01153386Phase 1
• The Effect of Renal Impairment on the Pharmacokinetics of Oral TreprostinilCompletedNCT01131845Phase 1
• Effect of Esomeprazole on the Pharmacokinetics of Oral TreprostinilCompletedNCT00963027Phase 1
• Effect of Food on the Pharmacokinetics of Oral TreprostinilCompletedNCT00963001Phase 1
• FREEDOM DR: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor or as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)WithdrawnNCT00760916Phase 3
• Study of Intravenous Remodulin in Patients in India With Pulmonary Arterial HypertensionTerminatedNCT00494533Phase 4
• A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial HypertensionCompletedNCT00058929Phase 4