Status:
COMPLETED
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)
Lead Sponsor:
United Therapeutics
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
12-70 years
Phase:
PHASE3
Brief Summary
This study was an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e., endothelin rec...
Eligibility Criteria
Inclusion
- Between 12 and 70 years of age, inclusive.
- Body weight at least 45 kg (approximately 100 pounds).
- PAH that is either idiopathic/heritable (including PAH associated with appetite suppressant/toxin use); PAH associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); PAH associated with collagen vascular disease; or PAH associated with HIV.
- Baseline 6-minute walk distance between 150 and 450 meters, inclusive.
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT00325442
Start Date
October 1 2006
End Date
December 1 2010
Last Update
August 2 2017
Active Locations (72)
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1
University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
2
Arizona Pulmonary Specialist
Phoenix, Arizona, United States, 85013
3
University of Arizona Health Science Center
Tucson, Arizona, United States, 85724
4
West Los Angeles VA Healthcare Center
Los Angeles, California, United States, 90073