6 results
1. To explore the pharmacokinetics (PK) of intra-vaginal delivery of gonadorelin and oxybutynin. 2. To assess the safety and tolerability of gonadorelin and oxybutynin delivery with a prototype intra-vaginal ring.
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…
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 12) in subjects with PAH who are not currently receiving ERA, PDE-5…
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…
To determine the safety, feasibility and efficacy of targeted left ventricular lead placement with CRT procedures, using the CARTBox software.
To establish the efficacy of targeted LV lead delivery in a sufficiently powered randomized, multicentre study. Efficacy is determined based on the distance of the LV-lead to the targeted cardiac segment, as determined pre-implantation by CARTBox.