Overview

FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)

Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
0
Participant gender:
All
Summary
This study was an international, multicenter, randomized (2:1 active:placebo), double-blind, placebo-controlled study in subjects with PAH who were NOT currently receiving approved therapy for their PAH. Study visits occurred at 4 week intervals for 12 weeks (with an additional visit at Week 11) with the key measure of efficacy being the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Two optional substudies were also a part of FREEDOM-M at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and Week 12. Patients who completed all assessments for 12 weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
United Therapeutics
Treatments:
Treprostinil
Criteria
Inclusion Criteria:

- Between 12 and 75 years of age, inclusive.

- Body weight at least 40 kg with a Body Mass Index < 45

- PAH that is either idiopathic/heritable; associated with repaired congenital
systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular
disease; associated with HIV.

- Previous testing (e.g., right heart catheterization, echocardiography) consistent with
the diagnosis of PAH.

- Baseline 6-minute walk distance between 200 and 425 meters, inclusive.

- Reliable and cooperative with protocol requirements.

Exclusion Criteria:

- Nursing or pregnant.

- Currently receiving an endothelin receptor antagonist, a phosphodiesterase-5
inhibitor, or prostacyclin within 30 days of Baseline.

- 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.