Overview

Assess Efficacy of of Oral Treprostinil in Patients With Symptomatic Primary or Secondary Raynaud's Phenomenon

Status:
Recruiting
Trial end date:
2021-07-01
Target enrollment:
Participant gender:
Summary
This study represents the first trial to assess the efficacy of oral treprostinil therapy in patients with symptomatic primary or secondary Raynaud's Phenomenon (RP) resistant to vasodilatory therapy. The study will be randomized 1:1 UT-15C to placebo. The design is a crossover study and all subjects will be randomized to receive oral treprostinil sustained release tablets or matching placebo for 12 weeks and then crossover for 12 weeks. All subjects will be exposed for 12 weeks of treatment with oral UT-15C during the study.
Phase:
Early Phase 1
Details
Lead Sponsor:
Brigham and Women's Hospital
Collaborator:
United Therapeutics
Treatments:
Treprostinil