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Clinical Trials​
 

  • UNISUS: A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg. (Awaiting site initiation)
     

  • A DUE: Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy. (Awaiting site initiation)

 

  • CATALYST: Clinical Study Protocol RTA 402-C-1504, A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (Closed for enrollment)
     

  • RANGER: An Extended Access Program to Assess Long-Term Safety of Bardoxolone Methyl in Patients with Pulmonary Hypertension (Closed for enrollment)
     

  • TORREY STUDY: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH). (Enrolling)
     

  • ALIS INS 415 and 416: A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC). (Awaiting site initiation)
     

  • ASPEN: A global, randomized, double-blind, placebo-controlled Phase 3 study to assess the efficacy, safety, and tolerability of brensocatib in patients with non-CF bronchiectasis. (Awaiting site initiation)

  • OPUS: AC-055-503, US-based, observational, drug registry of Opsumit® (macitentan) new users in clinical practice (Closed for enrollment)
     

  • PERFECT: A Phase 3, Randomized, Placebo-controlled, Double-blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD) (Enrolling)
     

  • BEAT: A Multicenter, Double-blind, Randomized, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of Oral BPS-314d-MR added-on to Treprostinil, Inhaled (Tyvaso®) in Subjects With Pulmonary Arterial Hypertension (Closed for enrollment)

 

 

  • PHAR: The PHAR is a multicenter, prospective registry of newly evaluated patients at PHCCs in the United States who have either PAH or CTEPH. Baseline information will be collected at the time of initial evaluation at the PHCC with follow-up data collected at approximately 6-month intervals (Enrolling)

 

  • PHASEBIO: A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension (Enrolling)

 

  • PHASEBIO OLE: A Long-Term, Open label Extension Study of PB1046 Subcutaneous Injections in Pulmonary Arterial Hypertension Subjects Following Completion of Study PB1046-PT-CL-0004 (Enrolling)

 

  • INTEGRIS IPF: A randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosis (IPF) (Enrolling)

 

  • ADVANCE Outcomes: A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH--specific background oral therapy in subjects with World Health Organization (WHO) Group 1 pulmonary hypertension (Enrolling)

 

  • ADVANCE Extension: A Phase 3 open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in subjects with World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) (Enrolling)

 

  • SPHERE: This is a US multi-center, prospective, real world, observational drug registry enrolling patients actively treated with Uptravi. Participating patients will be followed prospectively for a maximum of 18 months from the date of enrollment into the registry (Closed for enrollment)

 

  • SOUTHPAW: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects with Pulmonary Hypertension (PH) in Heart Failure with Preserved Ejection Fraction (HFpEF) (Closed for enrollment)

 

  • ADAPT: A Patient Registry of the Real-world Use of Orenitram (Enrolling)

 

     Publications

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