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An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension

NCT01027949 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 894

Last updated 2021-05-10

Study results available
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Summary

This study provided/continued to provide oral treprostinil (UT-15C SR; treprostinil diethanolamine) to eligible subjects who participated in Studies TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, and TDE-PH-308. The study assessed the long term safety of oral treprostinil and the effect of continued treatment with oral treprostinil on exercise capacity after 1 year of treatment.

Conditions

Interventions

DRUG

Oral Treprostinil

Oral sustained release tablet, twice or thrice daily. Open label study with active drug, no other intervention arms.

Sponsors & Collaborators

  • United Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-16
Primary Completion
2020-02-12
Completion
2020-02-12

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • China
  • France
  • Germany
  • India
  • Ireland
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • Puerto Rico
  • Spain
  • Sweden
  • 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 NCT01027949 on ClinicalTrials.gov