MedTrace Logo

Open-Label Study of Oral Treprostinil in Digital Ulcers

NCT00848107 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2024-06-18

Study results available
· View outcomes & findings →

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

DRUG

treprostinil diethanolamine

sustained release tablet; BID dosing; up to 16 mg BID

Sponsors & Collaborators

  • United Therapeutics

    lead INDUSTRY

Principal Investigators

  • James Seibold, MD · Scleroderma Research Consultants LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States
  • Canada
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00848107 on ClinicalTrials.gov