Pulmonary Arterial Hypertension MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Lung LLC
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the safety of long-term treatment with BPS-MR tablets in eligible patients who participated in the BPS MR PAH 203 study. ;Secondary Objective: The secondary objectives are to describe the efficacy of BPS-MR tablets on an unencouraged 6-Minute Walk Test (6MWT), the Borg Dyspnea Scale and Clinical Worsening in eligible patients who participated in the BPS MR PAH 203 study. ;Primary end point(s): The primary objective is to assess the safety of long-term treatment with BPS-MR tablets in eligible patients who participated in the BPS-MR-PAH-203 study.;Timepoint(s) of evaluation of this end point: Endpoint will be assessed at all study visits: Baseline, 3,6 and 12 months and annual visits and during Month 9 and quarterly phone calls. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objectives are to describe the efficacy of BPS-MR tablets on an unencouraged 6-Minute Walk Test (6MWT), the Borg Dyspnea Scale and Clinical Worsening in eligible patients who participated in the BPS-MR-PAH-203 study.;Timepoint(s) of evaluation of this end point: Endpoint will be assessed at all study visits: Baseline, 3,6 and 12 months and annual visits | — |
Countries
Belgium, Czech Republic, Germany, Ireland, Romania, United States
Contacts
Public ContactRené Mignolet
RLM Consulting
Outcome results
None listed