Open-Label Study of Oral Treprostinil in Digital Ulcers

Summary

This open label extension trial will allow ongoing treatment of subjects who participated in the randomized controlled trials, and will provide long term information about the safety of treprostinil diethanolamine SR in subjects with SSc and digital ulcers.

Timeline

Start

2009-09

Primary completion

2011-09

Completion

2011-09

Outcome

Outcome not reported

Stopped: “The TDE-DU-202 extension study was discontinued after the randomized, placebo-controlled TDE-DU-201 study did not meet its primary efficacy objective.”

Drugs

Indications