Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01908699 | Beraprost-314d Added-on to Tyvaso® (BEAT) | PHASE3 | COMPLETED | 273 | — | — | May 31, 2013 | Feb 19, 2019 | Aug 3, 2020 | 75 | United States, Israel |
The number of participants that experienced a Clinical Worsening event confirmed by Endpoint Adjudication Committee at First Maximum Severity. Clinical Worsening was defined as any of these events following the Baseline visit: Death (all causes); Hospitalization due to worsening PAH; Initiation of a parenteral (infusion or sub-cutaneous) prostacyclin, directly related to worsening PAH; Disease progression; Unsatisfactory long-term clinical response. The number of participants that experienced clinical worsening is presented; time to clinical worsening data was not measured. Given the rate of clinical worsening overall and the large number of censored observations at the end of the study, the mean survival time estimates were not available for this endpoint.
| Arm | Type | Description |
|---|---|---|
| Beraprost Sodium 314d Modified Release Tablets | EXPERIMENTAL | Available as 15 μg tablets for oral, 1 or 2 tablets four times daily (QID) administration. |
| Placebo | EXPERIMENTAL | Placebo tablets, which are identical in size and appearance to those containing BPS-314d-MR. |
| Name | Type | Description |
|---|---|---|
| Beraprost Sodium 314d Modified Release Tablets | DRUG | Available as 15 μg tablets for oral, 1 or 2 tablets four times daily (QID) administration |
| Placebo | DRUG | Placebo tablets, which are identical in size and appearance to those containing BPS-314d-MR |
Inclusion Criteria The following are inclusion criteria to be enrolled in this study: 1. Male or female, age 18 to 80 years (inclusive). 2. Established diagnosis of pulmonary arterial hypertension that is either idiopathic or familial PAH, collagen vascular disease associated PAH, PAH associated w...