View Clinical Trial (Medical Research Study)

A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Event Driven Study to Compare the Time to First Clinical Worsening in Subjects With Pulmonary Arterial Hypertension Receiving UT-15C in Combination With a PDE5-I or E

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Conditions:		Pulmonary Arterial Hypertension
Purpose:		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 31 to 90 days 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).
Study Summary:
Criteria:		Inclusion Criteria: 1. Between 18 and 75 years of age, inclusive 2. PAH that is idiopathic / heritable, PAH associated with connective tissue disease, HIV infection, repaired congenital systemic-to-pulmonary shunts (repaired > 1 year), or appetite suppressant / toxin use 3. Receiving a PDE-5 inhibitor or ERA at an appropriate dose 4. Previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of PAH Exclusion Criteria: 1. Nursing or pregnant 2. PAH due to conditions other than noted in the above inclusion criteria 3. History of uncontrolled sleep apnea, severe liver disease, left sided heart disease, uncontrolled systemic hypertension 4. Use of an investigational drug within 30 days of Baseline
NCT ID:		NCT01560624
Primary Contact:		N/A
Backup Contact:		N/A
Location Contact:		Norfolk, Virginia 23507 United States Melinda Bullivant Email: mmbulliv@sentara.com Site Status: Recruiting

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