Trial · NCT01908699
Beraprost-314d Added-on to Tyvaso® (BEAT)
NCT01908699, Phase 3, Completed, Lung Biotechnology PBC; results first posted 2020-02-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Beraprost-314d Added-on to Tyvaso® (BEAT). Trials, record NCT01908699. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01908699
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Beraprost-314d Added-on to Tyvaso® (BEAT)
- NCT number
- NCT01908699
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 273 participants, actual
- Lead sponsor
- Lung Biotechnology PBC
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Beraprost Sodium 314d Modified Release Tablets, Placebo
- First posted
- 2013-07-26
- Last updated
- 2020-08-03
- Results first posted
- 2020-02-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants That Experienced Clinical Worsening | up to 144 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Change From Baseline in Borg Dyspnea Score at Week 24 | Baseline and Week 24 | Only participants with both a measurement at baseline and at the given visit are presented. | scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in NT-pro-BNP Levels at Week 24 | Baseline and Week 24 | Only participants with both a measurement at baseline and at the given visit are presented. | picomole per liter (pmol/L) | MEAN |
| SECONDARY | Change in WHO Functional Class From Baseline to Week 24 | Baseline and Week 24 | Only participants with both a measurement at baseline and at the given visit are presented. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24 | Baseline and Week 24 | Only participants with both a measurement at baseline and at the given visit are presented. | meters | MEAN |
| SECONDARY | Number of Participants With TEAEs, Serious TEAEs, Investigations SOC TEAEs, and Serious Investigations SOC TEAEs | up to 144 weeks | Safety analysis population included all randomized participants who received at least 1 dose of study drug and analyzed as per the actual treatment received. Participants who received both esuberaprost and placebo were assigned to the esuberaprost group. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants That Experienced Clinical Worsening | Esuberaprost | Death (all causes) | 8 | Participants | |
| Number of Participants That Experienced Clinical Worsening | Placebo | Death (all causes) | 13 | Participants | |
| Number of Participants That Experienced Clinical Worsening | Esuberaprost | Hospitalization due to worsening PAH | 23 | Participants | |
| Number of Participants That Experienced Clinical Worsening | Placebo | Hospitalization due to worsening PAH | 14 | Participants | |
| Number of Participants That Experienced Clinical Worsening | Esuberaprost | Initiation of a parenteral prostacyclin | 7 | Participants | |
| Number of Participants That Experienced Clinical Worsening | Placebo | Initiation of a parenteral prostacyclin | 13 | Participants | |
| Number of Participants That Experienced Clinical Worsening | Esuberaprost | Disease progression | 6 | Participants | |
| Number of Participants That Experienced Clinical Worsening | Placebo | Disease progression | 4 | Participants | |
| Number of Participants That Experienced Clinical Worsening | Esuberaprost | Unsatisfactory long-term clinical response | 5 | Participants | |
| Number of Participants That Experienced Clinical Worsening | Placebo | Unsatisfactory long-term clinical response | 7 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Esuberaprost | 137 | |
| Overall Study | STARTED | Placebo | 136 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Esuberaprost | 136 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo | 135 | |
| Overall Study | COMPLETED | Esuberaprost | 62 | |
| Overall Study | COMPLETED | Placebo | 58 | |
| Overall Study | NOT COMPLETED | Esuberaprost | 75 | |
| Overall Study | NOT COMPLETED | Placebo | 78 |
Source ClinicalTrials.gov
Adverse events430
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Esuberaprost | 10 | 137 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 7 | 136 | |
| other | Acute kidney injury | Renal and urinary disorders | Esuberaprost | 5 | 137 | |
| other | Acute kidney injury | Renal and urinary disorders | Placebo | 7 | 136 | |
| other | Anaemia | Blood and lymphatic system disorders | Esuberaprost | 12 | 137 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 8 | 136 | |
| other | Anxiety | Psychiatric disorders | Esuberaprost | 3 | 137 | |
| other | Anxiety | Psychiatric disorders | Placebo | 10 | 136 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Esuberaprost | 14 | 137 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 17 | 136 |
1 to 10 of 430Source ClinicalTrials.gov
See all 430 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Esuberaprost | 26 | 137 |
| Total, all-cause mortality | Placebo | 22 | 136 |
| Total, other adverse events | Esuberaprost | 135 | 137 |
| Total, other adverse events | Placebo | 132 | 136 |
| Total, serious adverse events | Esuberaprost | 75 | 137 |
| Total, serious adverse events | Placebo | 78 | 136 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Esuberaprost vs Placebo: deaths from any cause | Trial comparisons |
| Esuberaprost vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01908699
GET https://conductscience.org/api/trials/v1/NCT01908699/results?page=2