| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00989963 | Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH) | PHASE2 | COMPLETED | 36 | — | — | Feb 1, 2010 | Sep 13, 2011 | Sep 30, 2020 | 17 | United States, Belgium +4 |
| NCT00990314 | Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients | PHASE2 | COMPLETED | 31 | — | — | Nov 30, 2009 | Nov 30, 2013 | Sep 16, 2019 | 17 | United States, Belgium +4 |
| NCT00792571 | An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients | PHASE2 | COMPLETED | 18 | — | — | Feb 28, 2009 | Nov 30, 2013 | Dec 26, 2019 | 6 | United States, Belgium +1 |
| NCT00781885 | A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH Patients | PHASE2 | COMPLETED | 19 | — | — | Jan 31, 2009 | Sep 30, 2010 | Jun 9, 2020 | 6 | United States, Belgium +1 |
The change in Pulmonary Vascular Resistance (PVR) was evaluated from Baseline to Week 12. PVR is expressed in Wood Units or millimeters of Mercury per Liter per minute (mmHG/L/min)
The change in Cardiac Output was evaluated from Baseline to Week 12.
The change in mean Pulmonary Arterial Pressure (mPAP) was evaluated from Baseline to Week 12.
A treatment-emergent adverse event (TEAE) is defined as an event not present prior to the initiation of the treatment or any event already present that worsens in either intensity or frequency following exposure to the treatment. AEs occurring more than 3 days after the last day study drug was taken in the study was not included in the statistical analyses or summaries (except for subjects with adverse events leading to study drug withdrawn). Only TEAEs that occurred during the treatment period of the BPS-MR-PAH-204 study were summarized. Any adverse event starting prior to the first dose of study drug was excluded from the summary analyses and only presented in the data listings. All efficacy results are descriptive; no statistical analysis was conducted
A treatment-emergent adverse event (TEAE) is defined as an event not present prior to the initiation of the treatment or any event already present that worsens in either intensity or frequency following exposure to the treatment. AEs occurring more than 3 days after the last day study drug was taken in the study was not included in the statistical analyses or summaries (except for subjects with adverse events leading to study drug withdrawn). Only TEAEs that occurred during the treatment period of the BPS-MR-PAH-204 study were summarized. Any adverse event starting prior to the first dose of study drug was excluded from the summary analyses and only presented in the data listings. All efficacy results are descriptive; no statistical analysis was conducted.
A treatment-emergent adverse event (TEAEs) is defined as an event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. AEs occurring more than 3 days after the last day study drug is taken in the study will not be included in the statistical analyses or summaries (except for subjects with adverse events leading to study drug withdrawn). Only treatment-emergent adverse events occurring during the treatment period of the BPS-MR-PAH-202 study will be summarized. Any adverse event starting prior to the first dose of study drug will be excluded from the summary analyses and only presented in the data listings. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
A treatment-emergent adverse event (TEAE) is defined as an event not present prior to the initiation of the treatment or any event already present that worsens in either intensity or frequency following exposure to the treatment. AEs occurring more than 3 days after the last day study drug was taken in the study was not included in the statistical analyses or summaries (except for participants with adverse events leading to study drug withdrawn). Only TEAEs that occurred during the treatment period of the BPS-MR-PAH-202 study were summarized. Any adverse event starting prior to the first dose of study drug was excluded from the summary analyses and only presented in the data listings. All efficacy results are descriptive; no statistical analysis was conducted. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) | EXPERIMENTAL | Patients in the MTD treatment group will dose escalate weekly by 60µg b.i.d. until they reach the maximum dose of 600µg b.i.d. or they reach an intolerable dose which requires them to down-titrate by 60µg b.i.d. In these instances and at the Investigator's discretion, further attempts at dose escalation may be made. |
| Low Fixed Dose | EXPERIMENTAL | The low dose group will receive 60µg twice a day(b.i.d.) |
| High Fixed Dose | EXPERIMENTAL | Patients in the high dose group will dose escalate weekly by 60µg twice a day (b.i.d.) until they reach the fixed dose of 240µg b.i.d. Once patients in these treatment groups have reached their assigned maximum dose of active drug, |
| B.I.D | EXPERIMENTAL | Beraprost Sodium Modified Release Tablet, 60mcg, B.I.D (twice a day dosing) |
| Q.I.D | EXPERIMENTAL | Beraprost Sodium Modified Release Tablet, 60mcg, q.i.d (four times a day dosing) |
| Name | Type | Description |
|---|---|---|
| Beraprost Sodium Modified Release | DRUG | 60µg Tablets, twice a day for 12 weeks |
Inclusion Criteria: 1. IRB approved written informed consent has been obtained. 2. Male or female, age 18 to 75 years (inclusive). 3. Established diagnosis of pulmonary arterial hypertension that is either idiopathic or familial PAH, collagen vascular disease associated PAH, PAH induced by anorexig...