Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures
Terminated
United Therapeutics
Phase 3
2003-02-01
The purpose of this study is to assess and compare the safety of continuous and daily
subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned
vascular interventional procedures; and to determine the effect of Remodulin on wound healing
and treadmill walk distance.
Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)
Completed
United Therapeutics
Phase 3
2005-06-01
This is a double-blind placebo-controlled clinical investigation into the efficacy and
tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.
The primary outcome is the change in 6-minute walk distance from baseline to week 12.
FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)
Completed
United Therapeutics
Phase 3
2006-10-01
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).
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