3 results
To provide, or continue to provide, UT-15C SR for eligible subjects who participated in protocols TDE-PH-301 or TDE-PH-302 or TDE-PH-308 or additional UC-15C SR clinical protocols.To assess the long-term safety of UT-15C SR in these subjects through…
The primary objective of this clinical investigation is to investigate the effect of the Provox Luna system on compliance of HME use. Compliant use is defined as daily use of an HME for at least 20 hours per day 86% (=24/28; each study period is 4…
Primary: To assess the effect of UT-15C sustained release (SR) on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 16) in subjects with PAH.Secondary: To assess the effect of UT-15C SR…