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NCT01588405 · ClinicalTrials.gov registry record · Phase 2
Remodulin® to Oral Treprostinil Transition
A Phase 2 study, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
NCT01588405 is a Phase 2 study that has completed, run by United Therapeutics. The registered enrollment target is 33 participants.
The verdict
NCT01588405, a Phase 2 study, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
Study Summary
This multi-center, open-label study will assess the tolerability and safety of transitioning subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous intravenous (IV) or subcutaneous (SC) Remodulin infusion to oral treprostinil (UT-15C sustained release (SR) tablets). This study will consist of an in-hospital transition phase, dose optimization/evaluation phase, and follow up phase.
Interventions
- DRUG UT-15C SR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01588405
The ClinicalTrials.gov registry entry for NCT01588405 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 33 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 SR is the first listed.
NCT01588405 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01588405 about?
NCT01588405 is a clinical study titled "Remodulin® to Oral Treprostinil Transition". This multi-center, open-label study will assess the tolerability and safety of transitioning subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous intravenous (IV) or subcutaneous (SC) Remodulin infusion to oral treprostinil (UT-15C sustained release (SR) tablets). This study w...
What is the current status of trial NCT01588405?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2012-04. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01588405?
The interventions under investigation include: UT-15C SR (DRUG).
Who is sponsoring clinical trial NCT01588405?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
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