Beraprost-314d Added-on to Tyvaso® (BEAT)

Phase 3

Completed

Conditions: Pulmonary Arterial Hypertension

Interventions: Drug: Beraprost Sodium 314d Modified Release Tablets
Drug: Placebo

Registration Number: NCT01908699

Lead Sponsor: Lung Biotechnology PBC

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 273

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beraprost Sodium 314d Modified Release Tablets	Beraprost Sodium 314d Modified Release Tablets	Available as 15 μg tablets for oral, 1 or 2 tablets four times daily (QID) administration.
Placebo	Placebo	Placebo tablets, which are identical in size and appearance to those containing BPS-314d-MR.

Primary Outcome Measures

Name	Time	Method
Number of Participants That Experienced Clinical Worsening	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.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24	Baseline and Week 24	Area used for the Six Minute Walk Test (6MWT) was pre-measured at 30 meters in length. Rest periods were allowed if patient could no longer continue. If patient needed to rest, he/she could stand or sit and then begin again when rested but the clock continued to run. At the end of 6 minutes, the tester called "stop" while stopping the watch and then measured the distance walked. For purposes of the 6MWT, if patient was assessed at Baseline using oxygen therapy, all future 6MWT were conducted in the same manner.
Number of Participants With TEAEs, Serious TEAEs, Investigations SOC TEAEs, and Serious Investigations SOC TEAEs	up to 144 weeks	The number of participants experiencing overall Treatment-Emergent Adverse Adverse Events (TEAEs), serious TEAEs, Investigations SOC TEAEs, and serious Investigations SOC TEAEs were reported.Investigations SOC TEAEs were any event categorized within the Investigations System Order Class (SOC) and include adverse events due to physical examinations, vital signs, clinical laboratory parameters, and electrocardiogram findings.
Mean Change From Baseline in Borg Dyspnea Score at Week 24	Baseline and Week 24	The Borg dyspnea score was assessed prior to and following the completion of the 6MWT at Week 24. The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6MWT. Scores range from 0 (for the best condition) to 10 (for the worst condition).
Mean Change From Baseline in NT-pro-BNP Levels at Week 24	Baseline and Week 24	Plasma NT-proBNP concentration is a useful biomarker for PAH as it is associated with changes in right heart morphology and function.
Change in WHO Functional Class From Baseline to Week 24	Baseline and Week 24	Change from Baseline in participant clinical status was recorded according to the World Health Organization (WHO) Functional Class. A change from lower to higher functional class (i.e. 'III to IV' or 'II to III') was considered as a deterioration. A change from higher to lower functional class (i.e. 'III to II' or 'II to I') was considered as an improvement. All efficacy results are descriptive; no statistical analysis was conducted.

Trial Locations

Locations (75): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Cedars-Sinai Medical Center Heart Institute
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Beverly Hills, California, United States
Allianz Research Institute Inc.
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Fountain Valley, California, United States
University of California San Francisco - Fresno
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Fresno, California, United States
University of California - San Diego
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La Jolla, California, United States
University of California Los Angeles
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Los Angeles, California, United States
Keck Medical Center of USC
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Los Angeles, California, United States
Veterans Affairs Greater Los Angeles Healthcare System
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Los Angeles, California, United States
Center for Advanced Pulmonary Medicine
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Rancho Mirage, California, United States
University of California - San Francisco
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San Francisco, California, United States
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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States