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Study stopped prior to subject enrollment.
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This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor)or as a monotherapy treatment. Study visits will occur at 4 week intervals for 12 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. At the end of the first 12-weeks, the patient will be un-blinded. Patients will continue with another 12-Week open label portion with visits occuring at 4-week intervals.
Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM - EXT).
This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor)or as a monotherapy treatment. Study visits will occur at 4 week intervals for 12 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. At the end of the first 12-weeks, the patient will be un-blinded. Patients will continue with another 12-Week open label portion with visits occuring at 4-week intervals.
Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM - EXT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | placebo |
|
| UT-15C 0.25 mg | Active Comparator | UT-15C 0.25 mg |
|
| UT-15C 1 mg | Active Comparator | UT-15C 1 mg |
|
| UT-15C 5 mg | Active Comparator | UT-15C 5 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UT-15C 1 mg | Drug | UT-15C 1 mg |
| |
| UT-15C 0.25 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Change in six-minute walk distance from Baseline to Week 12 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Borg Dyspnea Score | 12 weeks | |
| Clinical Worsening Assessment | 12 weeks | |
| Dyspnea Fatigue Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Laliberte, PharmD | United Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35294 | United States | ||
| West Los Angeles VA Healthcare Center |
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| Drug |
UT-15C 0.25 mg |
|
| UT-15C 5 mg | Drug | UT-15C 5 mg |
|
| Placebo | Drug | Placebo |
|
| 12 weeks |
| Symptoms of PAH | 12 weeks |
| World Health Organization (WHO) Functional Class | 12 weeks |
| Trough 6-Minute Walk Distance | 12 weeks |
| Trough Borg Dyspnea Score | 12 weeks |
| Pro-B-type natriuretic peptide (Pro-BNP) | 12 weeks |
| Optional hemodynamic parameters | 12 weeks |
| Adverse events | 12 weeks |
| Clinical Laboratory parameters | 12 weeks |
| Electrocardiogram findings | 12 weeks |
| Los Angeles |
| California |
| 90073 |
| United States |
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| Pulmonary Hypertension Clinic | Aurora | Colorado | 80045 | United States |
| University of Iowa Health Care | Iowa City | Iowa | 52242 | United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| Washington University Hospital | St Louis | Missouri | 63110 | United States |
| Weill Cornell Medical Center | New York | New York | 10021 | United States |
| Columbia Presbyterian Medical Center | New York | New York | 10032 | United States |
| Mary M Parkes Center for Asthma, Allergy and Pulmonary Care - University of Rochester | Rochester | New York | 14643 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Lagacy Clinic Northwest | Portland | Oregon | 97210 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Texas Southwestern | Dallas | Texas | 75235 | United States |
| Intermountain Medical Center | Murray | Utah | 84157-7000 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| St. Vincent's Hospital | Sydney | New South Wales | Australia |
| Prince Charles Hospital | Brisbane | Australia |
| The Alfred Hospital | Melbourne | Australia |
| Instituto Nacional de Cardiologia | Mexico City | Mexico City | 14080 | Mexico |
| Unidad de Investigacion Clinica en Medicina (UDICEM) | Monterrey | Mexico |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C427248 | treprostinil |
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