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NCT01477333 · ClinicalTrials.gov registry record · Phase 2
Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®
A Phase 2 study, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT01477333 is a Phase 2 study that has completed, run by United Therapeutics. The registered enrollment target is 18 participants.
The verdict
NCT01477333, a Phase 2 study, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
The purpose of this multi-center, open-label, safety and tolerability study was to assess the addition of oral treprostinil (UT-15C sustained release \[SR\] tablets) to subjects currently receiving Tyvaso (treprostinil) inhalation solution. During the 24-week evaluation period, the study evaluated the changes in the following assessments: hemodynamics, 6-minute walk test (6MWT), Borg dyspnea score, N-Terminal pro-brain natriuretic peptide (NT-proBNP), World Health Organization (WHO) Functional Class, and safety assessments. Eligible subjects had a diagnosis of pulmonary arterial hypertension (PAH), currently were receiving Tyvaso, and may have been receiving other approved PAH specific oral therapies (endothelin receptor antagonists \[ERAs\] and/or phosphodiesterase type 5 inhibitor \[PDE5-I\], if at a stable dose for ≥30 days). At Baseline, subjects received the first dose of 0.125 mg UT-15C SR.
Interventions
- DRUG UT-15C SR
- DRUG Tyvaso Inhalation Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01477333
The ClinicalTrials.gov registry entry for NCT01477333 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 18 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 2 interventions - of which UT-15C SR is the first listed.
NCT01477333 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01477333 about?
NCT01477333 is a clinical study titled "Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®". The purpose of this multi-center, open-label, safety and tolerability study was to assess the addition of oral treprostinil (UT-15C sustained release \[SR\] tablets) to subjects currently receiving Tyvaso (treprostinil) inhalation solution. During the 24-week evaluation period, the study evaluated t...
What is the current status of trial NCT01477333?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2011-10. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01477333?
The interventions under investigation include: UT-15C SR (DRUG), Tyvaso Inhalation Solution (DRUG).
Who is sponsoring clinical trial NCT01477333?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
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