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BPS-MR Extension in PAH
NCT00792571Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2009
- Primary completion
- Nov 2013
- Countries
- 3
- Sponsor
- Lung Biotechnology PBC
- Modality
- Orthosteric Ligands
- Drugs
- beraprost
- Conditions
- pulmonary arterial hypertension (PAH)
01
Overview
Phase 2, open-label trial of beraprost in pulmonary arterial hypertension (PAH) (2 arms), sponsored by Lung Biotechnology PBC. Primary endpoints: Number of Participants Reporting at Least One Treatment-Emergent Adverse Event up to 56 months and Number of Treatment Emergent Adverse Events Reported During The Study up to 56 months. Started Feb 2009; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
B.I.D Dosing
Beraprost Sodium Modified Release 60mcg BID
Q.I.D Dosing
Beraprost Sodium Modified Release 60mcg QID (Optional Substudy)
03
Who it enrols
Patients who completed the BPS-MR-PAH-201 study and volunteered to continue treatment. Excludes pregnant/lactating women and those who discontinued the previous study.
04
Endpoints
Primary
Number of Participants Reporting at Least One Treatment-Emergent Adverse Event
Number of Treatment Emergent Adverse Events Reported During The Study
Secondary
Mean Change From Baseline in Six Minutes Walk Distance
Change From Baseline in Borg Dyspnea Score
Number of Participants That Experienced Clinical Worsening During the Study
Number of Participants With a Change in WHO Functional Class
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