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NCT03496623 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Participants With Pulmonary Hypertension (PH) Due to Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by United Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 188
- Enrollment target
NCT03496623: Clinical Trial Phase 3 study, sponsored by United Therapeutics.
NCT03496623 is a Phase 3 study that was terminated before completion, run by United Therapeutics. The registered enrollment target is 188 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03496623, a Phase 3 study, was terminated before completion, sponsored by United Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 188 participants
- Enrollment target
Study Summary
The primary objective of this study is to demonstrate the efficacy of inhaled treprostinil compared to placebo in improving exercise ability as measured by change from baseline in 6-Minute Walk Distance (6MWD) following 12 weeks of active treatment in participants with PH-COPD.
Primary Outcome
6 MWD was calculated at peak exposure (10 to 60 minutes after dosing). 6MWT was performed by standardized procedures for all participants. Participants were asked to walk a set course for 6 minutes (timed) and the distance walked (in meters) was recorded. Statistical analyses were not performed due to lack of appropriate sample size.
Interventions
- DRUG Placebo solution
- DRUG Inhaled treprostinil solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2018-05-08 |
| Est. Completion | 2022-10-13 |
| Phase | Phase 3 |
Why NCT03496623 stopped before completion
NCT03496623 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo solution is the first listed.
NCT03496623 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03496623 about?
NCT03496623 is a clinical study titled "A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Participants With Pulmonary Hypertension (PH) Due to Chronic Obstructive Pulmonary Disease (COPD)". The primary objective of this study is to demonstrate the efficacy of inhaled treprostinil compared to placebo in improving exercise ability as measured by change from baseline in 6-Minute Walk Distance (6MWD) following 12 weeks of active treatment in participants with PH-COPD.
What is the current status of trial NCT03496623?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 188 participants. The study started on 2018-05-08. Estimated completion is 2022-10-13.
What interventions are being tested in trial NCT03496623?
The interventions under investigation include: Placebo solution (DRUG), Inhaled treprostinil solution (DRUG).
Who is sponsoring clinical trial NCT03496623?
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 NCT03496623's enrollment target sits among peer trials
188 1408th of 2000 higher than 591 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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