FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH) - Tabular View

Tracking Information
First Received Date ^ICMJE	May 11, 2006
Last Updated Date	September 25, 2008
Start Date ^ICMJE	May 2006
Current Primary Outcome Measures ^ICMJE (submitted: October 3, 2006)	Change in 6-minute walk distance from Baseline to Week 16
Original Primary Outcome Measures ^ICMJE (submitted: May 11, 2006)	Change in 6-minute walk distance from baseline to Week 16.
Change History	Complete list of historical versions of study NCT00325442 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 11, 2006)	Borg dyspnea score Clinical Worsening Assessment Dyspnea-Fatigue Index World Health Organization Functional Classification for PAH Symptoms of PAH Adverse events Clinical laboratory parameters Electrocardiogram findings
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)
Official Title ^ICMJE	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial Hypertension
Brief Summary	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). Study visits will occur at 4 week intervals for 16 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. One optional substudy is also a part of FREEDOM-C at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16. Patients who complete all assessments for 16-weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM - EXT).
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Pulmonary Hypertension
Intervention ^ICMJE	Drug: Oral treprostinil (UT-15C) Sustained Release Tablets
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	300
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Between 12 and 70 years of age, inclusive. Body weight at least 45 kg (approximately 100 pounds). PAH that is either idiopathic/familial; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular disease; associated with HIV. Currently receiving an approved endothelin receptor antagonist and/or an approved phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least the last 30 days. Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH. Reliable and cooperative with protocol requirements. Exclusion Criteria: Nursing or pregnant. Received a prostacyclin within the past 30 days. PAH due to conditions other than noted in the above inclusion criteria. History of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart disease, uncontrolled systemic hypertension, or parenchymal lung disease. Use of an investigational drug within 30 days of Baseline.
Gender	Both
Ages	12 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Australia, Austria, Belgium, Canada, France, Ireland, Israel, Italy, Netherlands, Poland, Spain, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00325442
Responsible Party
Study ID Numbers ^ICMJE	TDE-PH-301
Study Sponsor ^ICMJE	United Therapeutics
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	United Therapeutics
Verification Date	September 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP