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Research | Pulmonary Hypertension Clinical Trials

Clinical Trials

Actively 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.

The primary objective of this study is to compare the effect of BPS-314d-MR versus placebo added to treprostinil, inhaled (Tyvaso®) on the composite endpoint of time-to-clinical-worsening (TtCW) in patients with Pulmonary Arterial Hypertension. A secondary objective is to evaluate the safety of BPS-314d-MR based on adverse events, clinical laboratory parameters, electrocardiogram (ECG) findings, physical examination and vital signs.

Actively Enrolling:

FREEDOM Main Study:  A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy

This study is an international, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are currently receiving PDE-5 inhibitor or ERA for at least 30 days but not more than one year prior to randomization for their PAH. Study visits will occur in four week intervals for the first 12 weeks, then every 12 weeks thereafter with key measures of efficacy being time to first clinical worsening event and the 6-minute walk test at Week 24. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Patients who complete all required assessments will also be eligible to enter a long-term, open-label, extension study (TDE-PH-311).

Actively Enrolling:

FREEDOM Extension Study:  An Open-Label, Long-Term Study of Oral Treprostinil in Subjects with Pulmonary Arterial Hypertension

This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.

Actively Enrolling:

OPUS REGISTRY (OPsumit USers Registry) US-based, observational, drug registry of Opsumit® (macitentan) new users in clinical practice

Prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.

Actively Enrolling:

CTEPH Registry Study

The U.S. CTEPH Registry is a multicenter, observational, U.S.-based study of the clinical course and treatment of patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH), WHO Group IV Classification for Pulmonary Hypertension. The mission of the Registry will be to promote a greater understanding of the prevalence, pathophysiology, evaluation, and treatment of patients with CTEPH through shared information, education, and collaborative investigation among pulmonary hypertension (PH) centers of excellence throughout the U.S.

Actively Enrolling:

PORTICO: A randomized, double-blind, placebo-controlled, prospective, multicenter, parallel group study to assess the safety and efficacy of macitentan in patients with portopulmonary hypertension