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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 is a Phase 3 study that was terminated before completion, run by United Therapeutics. The registered enrollment target is 188 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03496623
The ClinicalTrials.gov registry entry for NCT03496623 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 188 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 Placebo solution is the first listed.
NCT03496623 reports 0 study locations.
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.
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