Phase 2
Completed N=31
Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients
Source: ClinicalTrials.gov NCT00990314 ↗Enrolled (actual)
31
Serious AEs
35.5%
Results posted
Sep 2019
Primary outcomePrimary: Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) — 27 Participants
Summary
This is an open-label study for patients who participated in the BPS-MR-PAH-203 study and have volunteered to continue treatment for PAH with Beraprost Sodium Modified Release (BPS-MR) tablets.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) |
27 | — |
| PRIMARY Number of Reported Treatment-Emergent Adverse Events |
230 | — |
| SECONDARY Change in Six-Minute-Walk Distance (6MWD) |
24.09 | — |
| SECONDARY Change in Borg Dyspnea Score |
0.86 | — |
| SECONDARY Number of Participants That Experienced Clinical Worsening |
1; 2; 4; 0 | — |
| SECONDARY Number of Participants With a Change in WHO Functional Class |
2; 7; 5; 1; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who remained on study drug and completed all assessments during the Treatment Phase of Study BPS MR PAH 203 are eligible for this study.
- Women of child-bearing potential (defined as less than 1 year post-menopausal or not surgically sterile) must be using an acceptable method of birth control or practicing abstinence. If sexually active, female patients must use a double barrier method of birth control, such as a condom and spermicidal.
Exclusion Criteria
- Patients who discontinued study drug during the previous study (BPS MR PAH 203) 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 (NCT00990314). 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.