Remodulin® to Oral Treprostinil Transition
Completed · Phase 2
Conditions studied: Pulmonary Arterial Hypertension
In brief
This multi-center, open-label study will assess the tolerability and safety of transitioning subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous intravenous (IV) or subcutaneous (SC) Remodulin infusion to oral treprostinil (UT-15C sustained release (SR) tablets). This study will consist of an in-hospital transition phase, dose optimization/evaluation phase, and follow up phase.
Key facts
- Study ID
- NCT01588405
- Run by
- United Therapeutics
- People needed
- 33
- Starts
- 2012-04-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2016-05-16
Who can join
Age: 15 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Between 15 and 80 years of age, inclusive, weigh at least 40 kg and have a diagnosis of PAH
- Have stable disease as confirmed by recent right heart catheterization and a Baseline 6MWD of at least 250 meters
- Have been receiving Remodulin for at least 90 days and at a stable dose for at least 30 days prior to the Baseline visit; the dose of Remodulin must be between 25-75 ng/kg/min, inclusive
- Must be also receiving an endothelin receptor antagonist (ERA) and/or a phosphodiesterase-5 inhibitor (PDE-5i) for at least 90 days and have been at a stable dose for at least 30 days prior to Baseline
You may not qualify if…
- WHO functional class III and IV subjects will be excluded
Where it is running
- Arizona Pulmonary Specialists — Phoenix, Arizona, United States
- University of Arizona Clinical and Translational Science (CATS) Research Center — Tucson, Arizona, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- University of Rochester — Rochester, New York, United States
- The Ohio State University — Columbus, Ohio, United States
- University of Pittsburgh Medical Center (UPMC) — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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