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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 is a Phase 3 study that has completed, run by Lung Biotechnology PBC. The registered enrollment target is 273 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01908699
The ClinicalTrials.gov registry entry for NCT01908699 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 273 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lung Biotechnology PBC, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01908699 reports 0 study locations.
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.
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