An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 15 November 2021
• Main ID: NCT01560637
• Date of registration: 09/03/2012
• Prospective Registration: Yes
• Primary sponsor: United Therapeutics
• Public title: An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
• Scientific title: Open-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310
• Date of first enrolment: May 2012
• Target sample size: 471
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01560637
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Brazil, Canada, Chile, China, Denmark, France, Germany, Greece, India, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Singapore, Sweden, Taiwan, United Kingdom, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participated in United Therapeutics Study TDE-PH-310

Exclusion Criteria:

- Premature discontinuation of United Therapeutics Study TDE-PH-310 due to reasons other
than clinical worsening



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: UT-15C (treprostinil diethanolamine)

Primary Outcome(s)

Safety (e.g.number and frequency of adverse events, changes in laboratory parameters from Baseline) [Time Frame: participants will be followed every 12 weeks, at minimum, until they discontinue the study or the study is discontinued by the sponsor or for a period up to 2.5 years]

Secondary ID(s)

TDE-PH-311

Source(s) of Monetary Support

Please refer to primary and secondary sponsors