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)

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).

Official Title

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

Conditions

Pulmonary Hypertension

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

• Primary Outcome Measures: Change in 6-minute walk distance from Baseline to Week 16
• Secondary Outcome Measures: 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

Study Start

May 2006

Eligibility & Criteria

• Ages Eligible for Study: 12 Years – 70 Years
• Genders Eligible for Study: Both

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.

Total Enrolment

300

Contact Details

Royal Perth Hospital, Perth, Australia; Recruiting

• Eli Gabbay, MD +61 8 9224 1977 eli.gabbay@health.wa.gov.au

The Alfred Hospital, Melbourne, Australia; Recruiting

• Trevor Williams, MD +61 3 9276 2489 t.williams@alfred.org.au
• Tania Dunne +61 3 3276 2743 T.Dunne@alfred.org.au

Prince Charles Hospital, Brisbane, Australia; Recruiting

• Keith McNeill, MD +61 7 3139 5811 Keith_Mcneil@health.qld.gov.au
• Donna Fry +61 7 3139 5076 Donna_Fry@health.qld.gov.au

St. Vincent’s Hospital, Sydney, New South Wales, Australia; Recruiting

• Anne Keogh, MD +61 2 83 82 3267 amkeogh@stvincents.com.au
• Karen Brown +61 2 83 82 3723 kmabrown@stvincents.com.au