Phase 2
Completed N=18
An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients
Source: ClinicalTrials.gov NCT00792571 ↗Enrolled (actual)
18
Serious AEs
38.9%
Results posted
Dec 2019
Primary outcomePrimary: Number of Participants Reporting at Least One Treatment-Emergent Adverse Event (TEAE) — 18 Participants
Summary
This is an open-label extension study for patients who participated in the BPS-MR-PAH-201 study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting at Least One Treatment-Emergent Adverse Event (TEAE) |
18 | — |
| PRIMARY Number of Treatment Emergent Adverse Events Reported During The Study |
156 | — |
| SECONDARY Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at End of Study |
10.55 | — |
| SECONDARY Change From Baseline in Borg Dyspnea Score at End of Study |
-0.09 | — |
| SECONDARY Number of Participants That Experienced Clinical Worsening During the Study |
1; 6; 0; 0 | — |
| SECONDARY Number of Participants With a Change in WHO Functional Class |
1; 7; 4; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who remained on study drug and completed all assessments during the Treatment Phase of Study BPS-MR-PAH-201 are eligible for this study.
- Female patients must either be physiologically incapable of childbearing or be practicing an acceptable method of birth control (e.g. approved hormonal contraceptive, barrier method, such as condom or diaphragm, used with a spermicide, or an intrauterine device).
Exclusion Criteria
- Patients who discontinued study drug during the previous study (BPS-MR-PAH-201) for any reason (e.g. treatment related adverse events) are not eligible for entry into this study.
- Patients who are pregnant or lactating are excluded from participation in the open-label extension.
Data sourced from ClinicalTrials.gov (NCT00792571). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.