PAH Studies

Actively Enrolling

INCREASE:  A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Subjects With Pulmonary Hypertension Due to Parenchymal Lung Disease

This is a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded, placebo-controlled trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 314 patients at approximately 120 clinical trial centers. The treatment phase of the study will last approximately 16 weeks.

Principal Investigator:  Hassan Alnuaimat, MD
Sub-Investigators: Ali Ataya, MD, Raju Reddy, MD

Clinicaltrials.gov link:  https://clinicaltrials.gov/ct2/show/NCT02630316?term=interstitial+lung+disease&cond=Pulmonary+Hypertension&draw=2&rank=15

If you are interested in participating in this study or would like more information, please contact Christina Eagan, DNP, APRN, FNP-BC at 352-273-8990.


OPUS: US-based, Observational, Drug Registry of Opsumit® (macitentan) New Users in Clinical Practice

This study is a multi-center observational registry study designed to observe newly patients who have been newly prescribed macitentan for pulmonary arterial hypertension.  It was designed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with maceitentan in the post-marketing setting.

Principal Investigator:  Hassan Alnuaimat, MD

Sub-Investigator: Ali Ataya, MD

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT02126943?term=registry+of+opsumit&rank=1

If you are interested in participating in this study or would like more information, please contact Christina Eagan, DNP, APRN, FNP-BC at 352-273-8990.


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)

This is a multicenter, randomized, double-blind, placebo-controlled, 30-week, adaptive cross-over study, with a Treatment Period of approximately 26 weeks under the Original Design or, if applicable, a 17-week parallel study, with a Treatment Period of approximately 14 weeks under the Contingent Design.

Principal Investigator:  Hassan Alnuaimat, MD

Sub-Investigators: Ali Ataya, MD, Raju Reddy, MD

Clinicaltrials.gov link:  https://clinicaltrials.gov/ct2/show/NCT03496623?term=COPD&cond=pulmonary+hypertension&draw=2&rank=18

If you are interested in participating in this study or would like more information, please contact Christina Eagan, DNP, APRN, FNP-BC at 352-273-8990.



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

This is a multi-center, randomized, double-blind, controlled, Phase 2 study to assess the safety, tolerability, and efficacy of PB1046 at the optimally titrated dose after 16 weeks of treatment. Subjects will be randomized in a 2:1 ratio to one of two parallel dose groups: a) high-dose group, or b) a low-dose group. The total treatment period will be comprised of 2 phases: 1) an initial 10 week dose titration phase in which weekly doses of PB1046 will be titrated (or sham titrated) up to a target dose level of at least 1.2 mg/kg or higher to the MTD, and 2) a maintenance of treatment phase that begins when subjects reach week 11 and continues for 6 weeks during which no further up-titration should occur.

Principal Investigator:  Hassan Alnuaimat, MD

Sub-Investigators: Ali Ataya, MD, Raju Reddy, MD

Clinicaltrials.gov link:  https://clinicaltrials.gov/ct2/show/NCT03556020?term=PhaseBio&cond=Pulmonary+Arterial+Hypertension&rank=2

If you are interested in participating in this study or would like more information, please contact Erin Silverman, PhD, CCRC at 352-273-5870 or Christina Eagan, DNP, APRN, FNP-BC at 352-273-8990.


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 Therapy in Subjects with World Health Organization (WHO) Group I PAH

Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.

Principal Investigator:  Hassan Alnuaimat, MD

Sub-Investigators: Ali Ataya, MD, Raju Reddy, MD

Clinicaltrials.gov link:  https://clinicaltrials.gov/ct2/show/NCT03626688?term=ralinepag&cond=Pulmonary+Arterial+Hypertension&rank=4

If you are interested in participating in this study or would like more information, please contact Erin Silverman, PhD, CCRC at 352-273-5870 or Christina Eagan, DNP, APRN, FNP-BC at 352-273-8990.


PRIMEx:  Phase 2 Multicenter, Double-Blind, Placebo Controlled, Efficacy, Safety, and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects with Pulmonary Arterial Hypertension (PAH)

This is a multicenter double-blind, placebo-controlled study to evaluate the safety, efficacy and pharmacokinetics of 2 doses of CXA-10 on stable background therapy in 96 subjects 18 to 80 years of age with PAH.

Principal Investigator:  Hassan Alnuaimat, MD

Sub-Investigators: Ali Ataya, MD, Raju Reddy, MD

Clinicaltrials.gov link:  https://clinicaltrials.gov/ct2/show/NCT03449524?term=complexa&cond=Pulmonary+Arterial+Hypertension&rank=2

If you are interested in participating in this study or would like more information, please contact Christina Eagan, DNP, APRN, FNP-BC at 352-273-8990.


Enrolling by Invitation:

INCREASE OLE: An Open-Label Extension study of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease

This is a multicenter, open-label trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 266 patients who completed all required assessments in the RIN-PH-201 study at approximately 100 clinical trial centers.

Principal Investigator:  Hassan Alnuaimat, MD

Sub-Investigators: Ali Ataya, MD, Raju Reddy, MD

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT02633293?term=interstitial+lung+disease&cond=Pulmonary+Hypertension&draw=2&rank=16

If you would like more information, please contact Christina Eagan, DNP, APRN, FNP-BC at 352-273-8990.


Uptravi® (SelexiPag): tHe usErs dRug rEgistry (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.

Principal Investigator:  Hassan Alnuaimat, MD

Clinicaltrials.gov link:  https://clinicaltrials.gov/ct2/show/NCT03278002?term=sphere&cond=Pulmonary+Arterial+Hypertension&rank=1

If you would like more information, please contact Erin Silverman, PhD, CCRC at 352-273-5870 or Christina Eagan, DNP, APRN, FNP-BC at 352-273-8990.


ADAPT – A Patient Registry of the Real-world Use of Orenitram®

This is a prospective, observational, multicenter, patient registry to observe and assess the real-world use and tolerability of Orenitram (treprostinil). Patients who are newly initiated on Orenitram for the treatment of pulmonary arterial hypertension (PAH) or who transition from another prostacyclin therapy will be evaluated for 52 weeks to observe dosing regimens, titration schedules, prostacyclin-related adverse events (AEs), and clinical outcomes of interest.

Principal Investigator:  Hassan Alnuaimat, MD

Sub-Investigator: Ali Ataya, MD

Clinicaltrials.gov link:  https://clinicaltrials.gov/ct2/show/NCT03045029?term=adapt+and+pah&rank=1

If you would like more information, please contact Christina Eagan, DNP, APRN, FNP-BC at 352-273-8990.


Closed to Enrollment:

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.

Principal Investigator:  Hassan Alnuaimat, MD

Sub-Investigators: Ali Ataya, MD, Raju Reddy, MD

Clinicaltrials.gov link:  http://clinicaltrials.gov/ct2/show/NCT01560637?term=TDE-PH-311&rank=2

If you would like more information, please contact Christina Eagan, DNP, APRN, FNP-BC at 352-273-8990.


A Phase 3 Open-label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861(Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients

The primary objective of this study is to evaluate the long-term safety and tolerability of LIQ861, a dry powder formulation of treprostinil, in patients with Pulmonary Arterial Hypertension (PAH). A secondary objective of this study is to evaluate the comparative bioavailability of treprostinil between two formulations of inhaled therapy.

Principal Investigator:  Hassan Alnuaimat, MD

Sub-Investigators: Ali Ataya, MD, Raju Reddy, MD

Clinicaltrials.gov link:  https://clinicaltrials.gov/ct2/show/NCT03399604?term=liquidia&cond=Pulmonary+Arterial+Hypertension&rank=3

If you would like more information, please contact Christina Eagan, DNP, APRN, FNP-BC at 352-273-8990.


Not Yet Enrolling:

A Global, Open-Label Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients

The primary objective of this study is to evaluate the long-term safety of LIQ861 in patients with pulmonary arterial hypertension (PAH).

Principal Investigator:  Hassan Alnuaimat, MD

Sub-Investigators: Ali Ataya, MD, Raju Reddy, MD

Clinicaltrials.gov link:  https://clinicaltrials.gov/ct2/show/NCT03992755?term=liquidia&cond=Pulmonary+Arterial+Hypertension&rank=2

If you would like more information, please contact Christina Eagan, DNP, APRN, FNP-BC at 352-273-8990.


ELEVATE1:  A Phase 2a, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of RVT-1201 in Patients with Pulmonary Arterial Hypertension

This is an exploratory Phase 2a, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of RVT-1201 in patients with pulmonary arterial hypertension (PAH).

Principal Investigator:  Ali Ataya, MD

Sub-Investigator: Raju Reddy, MD

Clinicaltrials.gov link:  https://clinicaltrials.gov/ct2/show/NCT03924154?term=rvt-1201&cond=Pulmonary+Arterial+Hypertension&rank=1

If you are interested in participating in this study or would like more information, please contact Erin Silverman, PhD, CCRC at 352-273-5870.

Closed Studies

PULSAR: A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)

Study A011-09 is designed to assess the efficacy and safety of sotatercept (ACE-011) relative to placebo in adults with pulmonary arterial hypertension (PAH). Eligible participants will receive study treatment for 6 months in the Placebo-Controlled Treatment Period, and then will be eligible to enroll into an 18- month Extension Period during which all participants will receive sotatercept.

Principal Investigator:  Hassan Alnuaimat, MD

Sub-Investigators: Ali Ataya, MD, Raju Reddy, MD

Clinicaltrials.gov link:  https://clinicaltrials.gov/ct2/show/NCT03496207?term=sotatercept&cond=Pulmonary+Arterial+Hypertension&rank=2

TRITON:  The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension

The objective of this clinical trial is to compare the efficacy and safety of an initial triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension.

Principal Investigator:  Hassan Alnuaimat, MD

Sub-Investigators: Ali Ataya, MD, Raju Reddy, MD

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT02558231?term=triton&cond=Pulmonary+Arterial+Hypertension&rank=1

BEAT OLE:  An Open-label Extension of BPS-314d-MR-PAH-302 in Pulmonary

Arterial Hypertension Patients

This is a multi-center, open-label study for eligible subjects who were actively participating in the BPS-314d-MR-PAH-302 study at the time the study was concluded. This OLE study will evaluate the safety, tolerability and efficacy of long-term treatment of the esuberaprost sodium tablets (Beraprost Sodium 314d Modified Release tablets) study drug.

Principal Investigator:  Hassan Alnuaimat, MD

Sub-Investigators: Ali Ataya, MD, Raju Reddy, MD

Clinicaltrials.gov link:  https://clinicaltrials.gov/ct2/show/NCT03657095?term=BEAT&cond=Pulmonary+Arterial+Hypertension&rank=1

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.

Principal Investigator:  Hassan Alnuaimat, MD

Sub-Investigators: Ali Ataya, MD, Raju Reddy, MD

Clinicaltrials.gov link: http://clinicaltrials.gov/ct2/show/NCT01908699?term=BEAT+PAH&rank=1

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).

Principal Investigator:  Hassan Alnuaimat, MD

Sub-Investigator: Ali Ataya, MD

Clinicaltrials.gov link:  http://clinicaltrials.gov/ct2/show/NCT01560624?term=TDE-PH-310&rank=2

United States CTEPH Registry

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.

Principal Investigator:  Hassan Alnuaimat, MD

Clinicaltrials.gov link:  https://clinicaltrials.gov/ct2/show/NCT02429284?term=cteph+registry&rank=1

LIBERTY: A Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1) (LIBERTY)

Ubenimex is being developed for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group 1) to improve exercise capacity and delay clinical worsening. This proof-of-concept study is designed as a Phase 2, multicenter, randomized, double-blind, placebo controlled study comparing ubenimex with placebo in patients with PAH (WHO Group 1) and have a WHO/New York Heart Association (NYHA) Functional Classification (WHO/NYHA-FC) of II or III.

The Primary Objectives for the study are:

  • To evaluate the efficacy of ubenimex in patients with PAH (WHO Group 1).
  • To evaluate the safety and tolerability of ubenimex in patients with WHO Group 1 PAH.

Principal Investigator:  Hassan Alnuaimat, MD

Sub-Investigator: Ali Ataya, MD

Clinicaltrials.gov link:  https://clinicaltrials.gov/ct2/show/NCT02664558?term=liberty&rank=13

LIBERTY2:  Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)

Ubenimex is being developed for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group 1) to improve exercise capacity and delay clinical worsening. This study is a Phase 2, open-label, multicenter, extension study to evaluate long-term safety and efficacy of ubenimex in patients with PAH (WHO Group 1) who complete Study EIG-UBX-001 (Study EIG-UBX-001 is a Phase 2, randomized, double-blind, placebo-controlled clinical trial) and meet the eligibility criteria for Study EIG-UBX-002.

The primary objective for this study is:

  • To obtain long-term safety and tolerability data for ubenimex (150 mg administered three times daily [TID]) in patients with PAH (WHO Group 1).

Principal Investigator:  Hassan Alnuaimat, MD

Sub-Investigator: Ali Ataya, MD

Clinicaltrials.gov link:  https://clinicaltrials.gov/ct2/show/NCT02736149?term=EIG-UBX-002&rank=1

A Randomized, Double-Blind, Placebo-Controlled, Prospective, Multicenter, Parallel Group Study to Assess the Safety and Efficacy of Macitentan in Patients with Portopulmonary Hypertension (PORTICO)

This study is a multi-site, international, double blind, placebo controlled 24-week study whose purpose is to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension. 

Principal Investigator:  Hassan Alnuaimat, MD

Sub-Investigator: Ibrahim Faruqi, MD

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT02382016?term=portico+and+macitentan&rank=1

Effects of Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Morbidity and Mortality in Symptomatic Patients With Pulmonary Arterial Hypertension – A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Prospective, Event Driven Phase IV Study

This study will investigate the effects of the combination of bosentan and sildenafil. Patients with symptomatic PAH treated with a stable dose of sildenafil equal to or greater than 20 mg t.i.d. for at least 12 weeks will be randomized to placebo or bosentan 125 mg b.i.d. All randomized patients will be treated with study drug until the predefined target number of morbidity/mortality events is reached.

Principal Investigator:  Hassan Alnuaimat, MD

ClinicalTrials.gov link: http://clinicaltrials.gov/ct2/show/NCT00303459

If you would like more information, please contact Christina Eagan, RN at 352-273-8990.

A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation Solution

This study is a surveillance of respiratory tract related adverse events in patients treated with Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies.

Principal Investigator:  Hassan Alnuaimat, MD

ClinicalTrials.gov link: http://clinicaltrials.gov/ct2/show/NCT01266265

SYMPHONY: A multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the PAH SYMPACT Instrument.

The purpose of this study is to assess and psychometrically validate a novel quality of life questionnaire for patients with pulmonary arterial hypertension in the setting of open label macitentan.  Secondary objectives are to evaluate the safety of macitentan and the effect of the drug on PAH symptoms and their impact as measured by the PAH SYMPACT Instrument.

Principal Investigator:  Hassan Alnuaimat, MD

Clinicaltrials.gov link:  http://clinicaltrials.gov/ct2/show/NCT01841762?term=SYMPHONY&rank=7

AMBITION: A Randomized, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

The purpose of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with Pulmonary Arterial Hypertension. This will be assessed by time to the first clinical failure event.

Principal Investigator:  Hassan Alnuaimat, MD

Sub-Investigator: Ibrahim Faruqi, MD

ClinicalTrials.gov link: http://clinicaltrials.gov/ct2/show/NCT01178073

REVEAL Registry™: Registry to Evaluate Early And Long-term PAH Disease Management

The REVEAL Registry™ is a multicenter, observational, U.S.-based study of the clinical course and disease management of pulmonary arterial hypertension (PAH) patients. All consecutive consenting patients diagnosed with WHO Group I PAH according to specific hemodynamic criteria at participating institutions will be enrolled. Participating patients will be followed for a minimum of five years from the time of enrollment.

Principal Investigator:  Hassan Alnuaimat, MD

ClinicalTrials.gov link: http://clinicaltrials.gov/ct2/show/NCT00370214