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NCT03794583 · ClinicalTrials.gov registry record · Phase 3
Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)
A Phase 3 study, sponsored by United Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 41
- Enrollment target
NCT03794583: Clinical Trial Phase 3 study, sponsored by United Therapeutics.
NCT03794583 is a Phase 3 study that was terminated before completion, run by United Therapeutics. The registered enrollment target is 41 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03794583, a Phase 3 study, was terminated before completion, sponsored by United Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 41 participants
- Enrollment target
Study Summary
This open-label study will evaluate the safety of continued therapy with inhaled treprostinil in participants who have completed Study RIN-PH-304 (NCT03496623). This study hypothesizes that long-term safety findings will be similar to those observed in the randomized, placebo-controlled, double-blind, adaptive study 'A Phase 3, Randomized, Placebo-controlled, Double-blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)(RIN-PH-304).
Primary Outcome
An adverse event (AE) can be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent was defined as any AE occurring/worsening at any time after a participant was exposed to study drug up until 7 days after the last dose of study drug. A summary of all Serious Adverse Events and Other Adverse
Interventions
- DRUG Inhaled treprostinil solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2018-12-21 |
| Est. Completion | 2022-11-29 |
| Phase | Phase 3 |
Why NCT03794583 stopped before completion
NCT03794583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Inhaled treprostinil solution is the first listed.
NCT03794583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03794583 about?
NCT03794583 is a clinical study titled "Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)". This open-label study will evaluate the safety of continued therapy with inhaled treprostinil in participants who have completed Study RIN-PH-304 (NCT03496623). This study hypothesizes that long-term safety findings will be similar to those observed in the randomized, placebo-controlled, double-blin...
What is the current status of trial NCT03794583?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 41 participants. The study started on 2018-12-21. Estimated completion is 2022-11-29.
What interventions are being tested in trial NCT03794583?
The interventions under investigation include: Inhaled treprostinil solution (DRUG).
Who is sponsoring clinical trial NCT03794583?
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 NCT03794583's enrollment target sits among peer trials
41 1877th of 2000 higher than 123 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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