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NCT01908699 · ClinicalTrials.gov registry record · Phase 3
Beraprost-314d Added-on to Tyvaso® (BEAT)
A Phase 3 study, sponsored by Lung Biotechnology PBC.
- Completed
- Registry status
- Phase 3
- Development phase
- 273
- Enrollment target
NCT01908699: Completed Phase 3 study, sponsored by Lung Biotechnology PBC.
NCT01908699 is a Phase 3 study that has completed, run by Lung Biotechnology PBC. The registered enrollment target is 273 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01908699, a Phase 3 study, has completed, sponsored by Lung Biotechnology PBC.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 273 participants
- Enrollment target
Study Summary
This is a multicenter, double-blind, randomized, placebo-controlled Phase 3 study, to assess the efficacy and safety of BPS-314d-MR when added-on to inhaled treprostinil (Tyvaso®)in patients with pulmonary arterial hypertension. Patients new to Tyvaso, will enter a run-in period on inhaled treprostinil until 90 days of experience is achieved to ensure drug tolerability before enrolling in the study. Treatment groups consist of one active and one placebo group. Subjects will be randomly allocated in a 1:1 ratio to one of the two treatment groups.
Primary Outcome
The number of participants that experienced a Clinical Worsening event confirmed by Endpoint Adjudication Committee at First Maximum Severity. Clinical Worsening was defined as any of these events following the Baseline visit: Death (all causes); Hospitalization due to worsening PAH; Initiation of a parenteral (infusion or sub-cutaneous) prostacyclin, directly related to worsening PAH; Disease progression; Unsatisfactory long-term clinical response. The number of participants that experienced c
Interventions
- DRUG Placebo
- DRUG Beraprost Sodium 314d Modified Release Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 273 participants |
| Start Date | 2013-05-31 |
| Est. Completion | 2019-02-19 |
| Phase | Phase 3 |
What the finished NCT01908699 record still lists
NCT01908699 is an interventional study that assigns participants to a tested intervention. The registered 273 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 (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01908699 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01908699 about?
NCT01908699 is a clinical study titled "Beraprost-314d Added-on to Tyvaso® (BEAT)". This is a multicenter, double-blind, randomized, placebo-controlled Phase 3 study, to assess the efficacy and safety of BPS-314d-MR when added-on to inhaled treprostinil (Tyvaso®)in patients with pulmonary arterial hypertension. Patients new to Tyvaso, will enter a run-in period on inhaled treprost...
What is the current status of trial NCT01908699?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 273 participants. The study started on 2013-05-31. Estimated completion is 2019-02-19.
What interventions are being tested in trial NCT01908699?
The interventions under investigation include: Placebo (DRUG), Beraprost Sodium 314d Modified Release Tablets (DRUG).
Who is sponsoring clinical trial NCT01908699?
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 NCT01908699's enrollment target sits among peer trials
273 1213th of 2000 higher than 787 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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