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NCT01560637 · ClinicalTrials.gov registry record · Phase 3
An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
A Phase 3 study, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 471
- Enrollment target
NCT01560637 is a Phase 3 study that has completed, run by United Therapeutics. The registered enrollment target is 471 participants.
The verdict
NCT01560637, a Phase 3 study, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 471 participants
- Enrollment target
Study Summary
This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.
Interventions
- DRUG UT-15C (treprostinil diolamine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 471 participants |
| Start Date | 2013-09-11 |
| Est. Completion | 2021-08-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01560637
The ClinicalTrials.gov registry entry for NCT01560637 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 471 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United Therapeutics, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which UT-15C (treprostinil diolamine) is the first listed.
NCT01560637 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01560637 about?
NCT01560637 is a clinical study titled "An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension". This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the eff...
What is the current status of trial NCT01560637?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 471 participants. The study started on 2013-09-11. Estimated completion is 2021-08-12.
What interventions are being tested in trial NCT01560637?
The interventions under investigation include: UT-15C (treprostinil diolamine) (DRUG).
Who is sponsoring clinical trial NCT01560637?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
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