Clinical Trials Directory

Trials / Terminated

TerminatedNCT00848107

Open-Label Study of Oral Treprostinil in Digital Ulcers

Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: An Open-label Multicenter Extension Study

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
115 (actual)
Sponsor
United Therapeutics · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGtreprostinil diethanolaminesustained release tablet; BID dosing; up to 16 mg BID

Timeline

Start date
2009-09-01
Primary completion
2011-09-01
Completion
2011-09-01
First posted
2009-02-20
Last updated
2024-06-18
Results posted
2014-02-07

Locations

26 sites across 3 countries: United States, Canada, United Kingdom

Source: ClinicalTrials.gov record NCT00848107. Inclusion in this directory is not an endorsement.