A Multicenter, Double-blind, Randomized, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of Oral BPS-314d-MR added-on to Treprostinil, Inhaled (Tyvaso®) in Subjects With Pulmonary Arterial Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 273
- 试验地点
- 75
- 主要终点
- Number of Participants That Experienced Clinical Worsening
研究概览
简要总结
This is a multicenter, double-blind, randomized, placebo-controlled Phase 3 study, to assess the efficacy and safety of BPS-314d-MR when added-on to inhaled treprostinil (Tyvaso®)in patients with pulmonary arterial hypertension.
Patients new to Tyvaso, will enter a run-in period on inhaled treprostinil until 90 days of experience is achieved to ensure drug tolerability before enrolling in the study.
Treatment groups consist of one active and one placebo group. Subjects will be randomly allocated in a 1:1 ratio to one of the two treatment groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Beraprost Sodium 314d Modified Release Tablets
Available as 15 μg tablets for oral, 1 or 2 tablets four times daily (QID) administration.
干预措施: Beraprost Sodium 314d Modified Release Tablets (Drug)
Placebo
Placebo tablets, which are identical in size and appearance to those containing BPS-314d-MR.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants That Experienced Clinical Worsening
时间窗: up to 144 weeks
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.
次要结局
- Mean Change From Baseline in Borg Dyspnea Score at Week 24(Baseline and Week 24)
- Mean Change From Baseline in NT-pro-BNP Levels at Week 24(Baseline and Week 24)
- Change in WHO Functional Class From Baseline to Week 24(Baseline and Week 24)
- Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24(Baseline and Week 24)
- Number of Participants With TEAEs, Serious TEAEs, Investigations SOC TEAEs, and Serious Investigations SOC TEAEs(up to 144 weeks)