Trial · NCT02468232
Outcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Had CEC (Clinical Endpoint Committee) Confirmed Composite Endpoints | up to 40 months | FAS consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Exposure-adjusted Incident Rate (EAIR) of CEC Confirmed Composite Endpoints | up to 40 months | FAS consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. | Events per 100 patient-years | NUMBER |
| SECONDARY | Key Secondary: Change From Baseline to the Pre-defined Time-points in Log-transformed Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) | Baseline, Weeks 4, 8 and Month 6 | FAS consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study.~This analysis is a longitudinal data analysis and all available data up to month 6 for each patient was used. Number of participants at each post-time point indicates the number of patients who have both baseline and post-time point values. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Key Secondary: Number of Participants With CEC-confirmed First Triple Composite Endpoint (Cardiovascular (CV) Death, Heart Failure (HF) Hospitalization, or Worsening of HF in Outpatients) | up to 40 months | FAS consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Key Secondary: EAIR of CEC-confirmed First Triple Composite Endpoint (Cardiovascular (CV) Death, Heart Failure (HF) Hospitalization, or Worsening of HF in Outpatients) | up to 40 months | FAS consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. | Events per 100 patient-years | NUMBER |
| SECONDARY | Key Secondary: Number of Participants by Changes in New York Heart Association (NYHA) Classification From Baseline at Predefined Timepoints | Baseline, Weeks 4, 8 and Month 6 | FAS consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. Number of participants at post-time point (i.e., n) indicates the number of patients who have post-time point values. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Key Secondary: Change From Baseline in Clinical Summary Score for Heart Failure Symptoms and Physical Limitations Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ). | Baseline, Week 8 and Month 6 | FAS consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. FAS included all patients with at least one KCCQ data. This is a longitudinal data analysis and all available data for each patient was used. Number of patients at each post-time point (n) indicates the number of patients who have both baseline and post-time point values. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Total Number of CEC Confirmed Composite of CV Death and Total (First and Recurrent) HF Hospitalizations for Heart Failure | up tp 40 months | The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. | Events per patient | NUMBER |
| SECONDARY | Number of Participants by Changes in Clinical Composite Score (as Assessed by NYHA Classification and Patient Global Assessment) at Predefined Timepoints | Baseline, Month 6 | The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. Overall Number of Participants Analyzed' indicates the number of patients who have post-time point values. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With All-cause Mortality | up to 40 months | The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | EAIR of All-cause Mortality | up to 40 months | The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. | Events per 100 patient-years | NUMBER |
| SECONDARY | Percentage of Participants Hospitalized | up to 40 months | The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Hospitalization Admissions Events Per-participant Per Year | up to 40 months | The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. | Hospitalization admissions per year | NUMBER |
| SECONDARY | Days in Intensive Care Unit (ICU) Per Participant Per Year | up to 40 months | The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. | Days per year | NUMBER |
| SECONDARY | Percentage of Re-hospitalizations | up to 40 months | The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Emergency Department/Urgent Care Facility Visits for HF Per Patient Per Year | up to 40 months | The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. | Visits per year | NUMBER |
| SECONDARY | Change in Blood NT-proBNP From Baseline | Baseline, Weeks 2, 4, 8 and Month 6 | The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. Number of participants at each post-time point (i.e., n) indicates the number of patients who have both baseline and post-time point values. | pg/mL | MEAN |
| SECONDARY | Change in Procollagen Type III N-Terminal Propeptide From Baseline | Baseline and Month 18 | The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. | ug/L | MEAN |
| SECONDARY | Changes in Urine Cyclic Guanosine 3',5'-Monophosphate (cGMP) From Baseline | Baseline, Weeks 4, 8 and Month 6 | The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. | nmol/L | MEAN |
| SECONDARY | Percentage of Participants Reaching Target Dose Level 3 at Week 8 and Maintained at Month 4 (Open Label Extension (OLE)) | Month 4 of OLE | FAS-Ext: The full analysis set for OLE epoch (FAS-Ext) included all subjects in the extension population who received at least one dose of the extension study drug. | 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/NCT02468232/outcomes