BPS-314d-MR-PAH-303 (BEAT OLE) (BEAT OLE)
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|ClinicalTrials.gov Identifier: NCT03657095|
Recruitment Status : Completed
First Posted : September 4, 2018
Last Update Posted : November 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Drug: Beraprost Sodium 314d Modified Release tablets||Phase 3|
Subjects will sign an informed consent to continue treatment for PAH with esuberaprost sodium tablets in this open-label extension (OLE) study. At the Enrollment Visit for this study, subjects will begin a blinded transition from the BPS-314d-MR-PAH-302 study to the OLE study over a 4-week period. The first dose for all subjects in this OLE study will be 2 tablets. During this blinded transition period, those subjects on active study drug in the BPS-314d-MR-PAH-302 study will continue with blinded active study drug 4-times daily (QID); those subjects on placebo study drug will receive one active tablet and one placebo tablet QID (blinded) during the first 2 weeks and increase to 2 active tablets QID (blinded) thereafter. After the first dose, the investigator may adjust the dose as medically warranted. The maximum dose for this study is 30 μg QID with a minimum accepted dose as 15 μg QID. For the first 4 weeks, contact with the subject should occur weekly to ensure up-titration to the fixed dose is tolerated and assess adverse events (AEs).
Subjects will return to the clinic at Week 4 to be supplied open-label esuberaprost sodium tablets and complete protocol specified procedures. At the Week 4 Visit, subjects will be dosed with two 15 μg tablets (30 μg total), administered orally QID (provided the target dose is tolerated) or follow the Investigator's (or designee's) directions if adjustment is needed. Following the Week 4 Visit, each subject will return to the clinic at Months 3, 6, 9, and 12, and quarterly thereafter for assessments.
At the conclusion of the study or if a subject discontinues the study prematurely, subjects will return to the clinic for an End-of-Study (EOS) Visit. Subjects will be provided instructions about down titration off esuberaprost sodium tablets by the investigator.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||112 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Treatment during the first 4 weeks of this study is double-blind. The investigator and study staff, the subjects, the monitors, and the sponsor will remain blinded to the treatment group allocation from BPS-314d-MR-PAH-302 study and to study drug during the first 4 weeks of the OLE study. After the 4 weeks, the study will continue as unblinded and open label.|
|Official Title:||An Open-label Extension of BPS-314d-MR-PAH-302 in Pulmonary Arterial Hypertension Patients|
|Actual Study Start Date :||December 10, 2018|
|Actual Primary Completion Date :||July 20, 2019|
|Actual Study Completion Date :||July 20, 2019|
Experimental: Beraprost Sodium 314d Modified Release tablets
15 μg esuberaprost sodium tablets (Beraprost Sodium 314d Modified Release tablets) for oral administration as 1 or 2 tablets four times a day (QID).
Drug: Beraprost Sodium 314d Modified Release tablets
15 μg esuberaprost sodium tablets (Beraprost Sodium 314d Modified Release tablets) for oral administration as 1 or 2 tablets four times a day (QID)
- Incidence of treatment-related adverse events [ Time Frame: Change in incidence from baseline to end of study, estimated up to 2 years. ]Descriptive analyses of all adverse events will be performed. Incidence will be described by the number of subjects analyzed and the percentage of those subjects who experienced an adverse event until study completion.
- Severity of treatment-related adverse events [ Time Frame: Change in incidence from baseline to end of study, estimated up to 2 years. ]
- 6 Minute Walk Distance (6MWD) [ Time Frame: Assessed at Week 4 and then every 12 weeks through study completion, estimated up to 2 years. ]Subjects will be instructed to walk down a corridor at a comfortable speed as far as they can manage for six minutes. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.
- Borg Dyspnea Score [ Time Frame: Assessed at Week 4 and then every 12 weeks through study completion, estimated up to 2 years. ]The modified 0-10 category-ratio Borg scale is one in which the subjects rate the maximum level of dyspnea they experienced during the Six-Minute Walk Test (6MWT). Scores range from 0 (for the best condition) and 10 (for the worst condition).
- World Health Organization (WHO) Functional Class (FC) [ Time Frame: Assessed at Week 4 and then every 12 weeks through study completion, estimated up to 2 years. ]The WHO Functional Class of pulmonary hypertension is a physical activity rating scale as follows: Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.
- N-terminal pro-brain natriuretic peptide (NT-pro-BNP) [ Time Frame: Assessed at Week 4 and then every 12 weeks through study completion, estimated up to 2 years. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657095