Pulmonary Arterial Hypertension (PAH)

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.

Principal Investigator: Hassan Alnuaimat, MD

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

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

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).

Principal Investigator: Hassan Alnuaimat, MD

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

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

Enrolling by Invitation:

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

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

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

Actively Enrolling:

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

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, RN at 352-273-8990.

Actively Enrolling:

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

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

Actively Enrolling:

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

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

If you are interested in participating in this study or would like more information, please contact Brooks Morgan, RN at 352-273-5870 or Christina Eagan, RN at 352-273-8990.

Closed:

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.

Closed:

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

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

Closed:

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

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

Closed:

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

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

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

Closed:

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

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