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Trial · NCT04788511

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)From baseline (week 0) to end of treatment (week 52)FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52.Score on a scaleMEAN
PRIMARYChange in Body WeightFrom baseline (week 0) to end of treatment (week 52)FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52.Percentage of body weightMEAN
SECONDARYChange in Six-minute Walking Distance (6MWD)From baseline (week 0) to end of treatment (week 52)FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52.MetersMEAN
SECONDARYThe Hierarchical Composite Endpoint: Percentage of Wins of Participant PairsFrom baseline (week 0) to end of study (week 57)FAS included all the randomized participants for this trial.Percentages of wins of participant pairsNUMBER
SECONDARYChange in C-Reactive Protein (CRP): Ratio to BaselineFrom baseline (week -2) to end of treatment (week 52)FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52.Ratio of C-reactive proteinGEOMETRIC_MEAN
SECONDARYPercentage of Participants Achieving 10 Percent (%) Weight Loss (Yes/No)From baseline (week 0) to end of treatment (week 52)FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52.Percentage of participantsNUMBER
SECONDARYPercentage of Participants Achieving 15% Weight Loss (Yes/No)From baseline (week 0) to end of treatment (week 52)FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52.Percentage of participantsNUMBER
SECONDARYPercentage of Participants Achieving 20% Weight Loss (Yes/No)From baseline (week 0) to end of treatment (week 52)FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52.Percentage of participantsNUMBER
SECONDARYPercentage of Participants Improving 5 Points or More in KCCQ Clinical Summary Score (Yes/No)From baseline (week 0) to end of treatment (week 52)FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52.Percentage of participantsNUMBER
SECONDARYPercentage of Participants Improving 10 Points or More in KCCQ Clinical Summary Score (Yes/No)From baseline (week 0) to end of treatment (week 52)FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52.Percentage of participantsNUMBER
SECONDARYChange in KCCQ Overall Summary Score (KCCQ-OSS)From baseline (week 0) to end of treatment (week 52)FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52.Score on a scaleMEAN
SECONDARYPercentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in KCCQ-CSS (PGI-S)From baseline (week 0) to end of treatment (week 52)FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52.Percentage of ParticipantsNUMBER
SECONDARYPercentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in 6MWD (PGI-S)From baseline (week 0) to end of treatment (week 52)FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52.Percentage of ParticipantsNUMBER
SECONDARYChange in Systolic Blood Pressure (SBP)From baseline (week -2) to end of treatment (week 52)FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52.millimetre of mercury (mmHg)MEAN
SECONDARYChange in Waist CircumferenceFrom baseline (week 0) to end of treatment (visit 52)FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed signifies those participants who had an observed value at week 52.CentimeterMEAN

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.

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