Status:
COMPLETED
FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)
Lead Sponsor:
United Therapeutics
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
Brief 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 P...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
349 Patients enrolled
Trial Details
Trial ID
NCT00325403
Start Date
October 1 2006
End Date
April 1 2011
Last Update
January 3 2024
Active Locations (77)
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1
University of Alabama-Birmingham
Birmingham, Alabama, United States
2
Arizona Pulmonary Specialist
Phoenix, Arizona, United States
3
Mayo Clinic Arizona
Phoenix, Arizona, United States
4
University of California, San Francisco-Fresno
Fresno, California, United States