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NCT03657095 · ClinicalTrials.gov registry record · Phase 3
A Study With BPS-314d-MR-PAH-303 in Participants With Pulmonary Arterial Hypertension
A Phase 3 study, sponsored by Lung Biotechnology PBC.
- Terminated
- Registry status
- Phase 3
- Development phase
- 112
- Enrollment target
NCT03657095: Clinical Trial Phase 3 study, sponsored by Lung Biotechnology PBC.
NCT03657095 is a Phase 3 study that was terminated before completion, run by Lung Biotechnology PBC. The registered enrollment target is 112 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03657095, a Phase 3 study, was terminated before completion, sponsored by Lung Biotechnology PBC.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 112 participants
- Enrollment target
Study Summary
This is a multi-center, open-label study for eligible participants who were actively participating in the BPS-314d-MR-PAH-302 double-blind study (NCT01908699) at the time the study was concluded. This open-label extension (OLE) study will evaluate the safety, tolerability, and efficacy of long-term treatment with esuberaprost sodium tablets (Beraprost Sodium 314d Modified Release tablets).
Primary Outcome
A TEAE is any untoward medical occurrence or undesirable event(s) experienced in a participant that begins or worsens following administration of study drug, whether or not considered related to study drug by Investigator. A serious adverse event (SAE) is an adverse event (AE) resulting in any of the following outcomes or deemed significant for any other reason, death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), or persistent or signific
Interventions
- DRUG Placebo
- DRUG Esuberaprost
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2018-12-10 |
| Est. Completion | 2019-07-20 |
| Phase | Phase 3 |
Why NCT03657095 stopped before completion
NCT03657095 is an interventional study that assigns participants to a tested intervention. The registered 112 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 (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03657095 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03657095 about?
NCT03657095 is a clinical study titled "A Study With BPS-314d-MR-PAH-303 in Participants With Pulmonary Arterial Hypertension". This is a multi-center, open-label study for eligible participants who were actively participating in the BPS-314d-MR-PAH-302 double-blind study (NCT01908699) at the time the study was concluded. This open-label extension (OLE) study will evaluate the safety, tolerability, and efficacy of long-term ...
What is the current status of trial NCT03657095?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 112 participants. The study started on 2018-12-10. Estimated completion is 2019-07-20.
What interventions are being tested in trial NCT03657095?
The interventions under investigation include: Placebo (DRUG), Esuberaprost (DRUG).
Who is sponsoring clinical trial NCT03657095?
This trial is sponsored by Lung Biotechnology PBC, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03657095's enrollment target sits among peer trials
112 1652nd of 2000 higher than 346 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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