An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 6
- 主要终点
- Number of Participants Reporting at Least One Treatment-Emergent Adverse Event (TEAE)
研究概览
简要总结
This is an open-label extension study for patients who participated in the BPS-MR-PAH-201 study.
详细描述
This is an open-label study for patients who participated in the BPS-MR-PAH-201 study and have volunteered to continue treatment for PAH with BPS-MR tablets. Each patient will return to the clinic following enrollment in the study at 3, 6, and 12 months, and annually thereafter for assessment.
Currently enrolled patients may be invited to participate in an optional four times daily (QID) dosing substudy of BPS-MR with total daily dose of BPS-MR achieved previously in the main study. Patients will return to the clinic for baseline visit, week 12, and then will follow the visit schedule provided to them in BPS-MR-PAH-202 main study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who remained on study drug and completed all assessments during the Treatment Phase of Study BPS-MR-PAH-201 are eligible for this study.
- •Female patients must either be physiologically incapable of childbearing or be practicing an acceptable method of birth control (e.g. approved hormonal contraceptive, barrier method, such as condom or diaphragm, used with a spermicide, or an intrauterine device).
排除标准
- •Patients who discontinued study drug during the previous study (BPS-MR-PAH-201) 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.
研究组 & 干预措施
B.I.D
Beraprost Sodium Modified Release Tablets, 60mcg, b.i.d (twice a day dosing)
干预措施: Beraprost Sodium Modified Release (Drug)
Q.I.D
Beraprost Sodium Modified Release Tablets, 60mcg, q.i.d (four times a day dosing)
干预措施: Beraprost Sodium Modified Release (Drug)
结局指标
主要结局
Number of Participants Reporting at Least One Treatment-Emergent Adverse Event (TEAE)
时间窗: Up to 56 months
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.
Number of Treatment Emergent Adverse Events Reported During The Study
时间窗: Up to 56 months
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.
次要结局
- Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at End of Study(Baseline and 56 months)
- Change From Baseline in Borg Dyspnea Score at End of Study(Baseline and 56 months)
- Number of Participants That Experienced Clinical Worsening During the Study(Up to 56 months)
- Number of Participants With a Change in WHO Functional Class(Baseline and 56 months)