Status:
TERMINATED
Open-Label Study of Oral Treprostinil in Digital Ulcers
Lead Sponsor:
United Therapeutics
Conditions:
Systemic Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 d...
Eligibility Criteria
Inclusion
- Eligible subjects who completed assessments for the final visit of the previous TDE-DU-201 controlled trial and who signed appropriate informed consent were eligible to enroll in this extension study.
- If a female of childbearing potential, the subject must have agreed to continue practicing an acceptable method of birth control (i.e., surgical sterilization, approved hormonal contraceptives, barrier methods \[such as a condom or diaphragm\] used with a spermicide, or an intrauterine device).
Exclusion
- Have had any change in clinical status that, in the opinion of the Investigator, would pose a safety risk for participation in this extension study;
- Have been found to be unable to complete study assessments in the previous controlled trial;
- Have prematurely discontinued study drug during the previous study due to clinical worsening or treatment related adverse events.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00848107
Start Date
September 1 2009
End Date
September 1 2011
Last Update
June 18 2024
Active Locations (26)
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1
University of Alabama - Birmingham - Arthritis Clinical Intervention Program
Birmingham, Alabama, United States, 35294-7201
2
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
3
UCLA
Los Angeles, California, United States, 90095-1670
4
Barbara Davis Centre
Aurora, Colorado, United States, 80045