Ignite Creation Date:
2024-05-06 @ 1:48 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01908699
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2013-07-16
Brief Title:
Beraprost-314d Added-on to Tyvaso BEAT
Sponsor:
Lung Biotechnology PBC
Organization:
Lung Biotechnology PBC
Study Overview
Official Title:
A Multicenter Double-blind Randomized Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Oral BPS-314d-MR added-on to Treprostinil Inhaled Tyvaso in Subjects With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEAT
Brief 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 Tyvasoin 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 11 ratio to one of the two treatment groups
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 11 ratio to one of the two treatment groups
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None