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NCT02261883 · ClinicalTrials.gov registry record · Phase 2
Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn
A Phase 2 study, sponsored by United Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT02261883: Clinical Trial Phase 2 study, sponsored by United Therapeutics.
NCT02261883 is a Phase 2 study that was terminated before completion, run by United Therapeutics. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02261883, a Phase 2 study, was terminated before completion, sponsored by United Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
This study assessed the safety and treatment effect of intravenous (IV) Remodulin as an add-on therapy in neonates with persistent pulmonary hypertension of the newborn (PPHN).
Primary Outcome
Clinical worsening was a composite endpoint defined by the occurrence of 1 of the following: death, initiation of ECMO per institutional policies, or need for additional treatment (initiation of additional targeted pulmonary vasodilator therapy).
Interventions
- DRUG Placebo
- DRUG IV Remodulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2015-07-29 |
| Est. Completion | 2023-05-17 |
| Phase | Phase 2 |
Why NCT02261883 stopped before completion
NCT02261883 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02261883 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02261883 about?
NCT02261883 is a clinical study titled "Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn". This study assessed the safety and treatment effect of intravenous (IV) Remodulin as an add-on therapy in neonates with persistent pulmonary hypertension of the newborn (PPHN).
What is the current status of trial NCT02261883?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2015-07-29. Estimated completion is 2023-05-17.
What interventions are being tested in trial NCT02261883?
The interventions under investigation include: Placebo (DRUG), IV Remodulin (DRUG).
Who is sponsoring clinical trial NCT02261883?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02261883's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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