Trial · NCT03439514
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Six-Minute Walk Test (6 MWT) at Week 24 | Baseline, Week 24 | Efficacy analysis set (EAS): NYHA functional Class II / III randomized participants. 'Number of Participants Analyzed' = participants evaluable for the outcome measure. Five participants (ARRY-371797 \[n=3\], placebo \[n=2\]) discontinued the study before week 24 due to the sponsor's decision to terminate and were excluded from the primary analysis. All participants reported under 'Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. | Meter | MEDIAN |
| SECONDARY | Change From Baseline in 6 MWT at Weeks 4 and 12 | Baseline, Week 4, Week 12 | EAS included all NYHA functional Class II or III randomized participants. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Number Analyzed signifies number of participants evaluable for specified rows of respective arms. | Meter | MEDIAN |
| SECONDARY | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Physical Limitation (PL) and Total Symptom Score (TSS) Domain Scores at Weeks 12 and 24 | Baseline, Week 12, Week 24 | EAS included all NYHA functional Class II or III randomized participants. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, Number Analyzed signifies participants evaluable for specified rows. | Units on a scale | MEAN |
| SECONDARY | Number of Participants With Improvement From Baseline in Patient Global Impression of Severity (PGI-S) Score at Weeks 12 and 24 | Week 12, Week 24 | EAS included all NYHA functional Class II or III randomized participants. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Number Analyzed signifies number of participants evaluable for specified rows of respective arms. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Improvement From Baseline in Patient Global Impression of Change (PGI-C) Score at Weeks 12 and 24 | Week 12, Week 24 | EAS included all NYHA functional Class II or III randomized participants. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Number Analyzed signifies number of participants evaluable for specified rows of respective arms. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) at Weeks 4, 12, and 24 | Baseline, Week 4, Week 12, Week 24 | EAS included all NYHA functional Class II or III randomized participants. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Number Analyzed signifies number of participants evaluable for specified rows of respective arms. | picomoles per liter | MEAN |
| SECONDARY | Composite Time to First Occurrence of All-Cause Mortality or Worsening Heart Failure (WHF) | Maximum up to 212.28 weeks (maximum exposure was 208 weeks) | The safety analysis set (SAS) included all participants who received at least 1 dose of study intervention regardless of NYHA functional class. | Weeks | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization up to death due to any cause or censored date, maximum up to 212.28 weeks (maximum exposure was of 208 weeks) | The SAS included all participants who received at least 1 dose of study intervention regardless of NYHA functional class. | Weeks | MEDIAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs) and by Severity | Maximum up to 212.28 weeks (maximum exposure was of 208 weeks) | The SAS included all participants who received at least 1 dose of study intervention regardless of NYHA functional class. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Test Abnormalities | Maximum up to 212.28 weeks (maximum exposure was of 208 weeks) | The SAS included all participants who received at least 1 dose of study intervention regardless of NYHA functional class. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants According to Categorization of Abnormal Vital Signs | Maximum up to 212.28 weeks (maximum exposure was of 208 weeks) | The SAS included all participants who received at least 1 dose of study intervention regardless of NYHA functional class. Here, Number Analyzed signifies number of participants evaluable for specified rows of respective arms. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants According to Categorization of Electrocardiogram (ECG) Data | Maximum up to 212.28 weeks (maximum exposure was of 208 weeks) | The SAS included all participants who received at least 1 dose of study intervention regardless of NYHA functional class. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows of respective arms. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a New Clinically Significant Ventricular or Atrial Arrhythmias | Baseline, Week 12, Week 24 | The SAS included all participants who received at least 1 dose of study intervention regardless of NYHA functional class. Here, Number Analyzed signifies number of participants evaluable for specified rows of respective arms. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT03439514/outcomes