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Trial · NCT02692716

Outcomes18

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYTime From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE) Composite Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal StrokeMaximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARY
Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, UAP Requiring Hospitalisation or Hospitalisation for Heart Failure
Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.Overall number of participants analyzed = FAS which comprised all randomised participants.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYTime From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular EndpointMaximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.Overall number of participants analyzed = FAS which comprised all randomised participants.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYTime From Randomisation to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, Non-fatal Myocardial Infarction or Nonfatal StrokeMaximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.Overall number of participants analyzed = FAS which comprised all randomised participants.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYTime From Randomisation to First Occurrence of Fatal or Non-fatal Myocardial InfarctionMaximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.Overall number of participants analyzed = FAS which comprised all randomised participants.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYTime From Randomisation to First Occurrence of Fatal or Non-fatal StrokeMaximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.Overall number of participants analyzed = FAS which comprised all randomised participants.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYTime From Randomisation to All-cause DeathMaximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 5 weeks of follow-up period.Overall number of participants analyzed = FAS which comprised all randomised participants.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYTime to First AE Leading to Permanent Trial Product DiscontinuationMaximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window.Overall number of participants analyzed = FAS which comprised all randomised participants.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Serious Adverse EventsMaximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window.Overall number of participants analyzed = FAS which comprised all randomised participants.EventsNUMBER
SECONDARYChange in Eye Examination CategoryWeek -3, End of treatmentOverall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange in Pulse RateWeek 0, End of treatmentOverall number of participants analyzed = number of participants with available data.Beats/minuteMEAN
SECONDARYChange in Systolic and Diastolic Blood PressureWeek 0, End of treatmentOverall number of participants analyzed = number of participants with available data.mmHgMEAN
SECONDARYChange in Glycosylated Haemoglobin (HbA1c)Week 0, End of treatmentOverall number of participants analyzed = number of participants with available data.Percentage of HbA1cMEAN
SECONDARYChange in Body WeightWeek 0, End of treatmentOverall number of participants analyzed = number of participants with available data.KgMEAN
SECONDARYChange in Total Cholesterol - Ratio to BaselineWeek 0, End of treatmentOverall number of participants analyzed = number of participants with available data.Ratio of total cholesterolGEOMETRIC_MEAN
SECONDARYChange in LDL-cholesterol - Ratio to BaselineWeek 0, End of treatmentOverall number of participants analyzed = number of participants with available data.Ratio of LDL-cholesterolGEOMETRIC_MEAN
SECONDARYChange in HDL-cholesterol - Ratio to BaselineWeek 0, End of treatmentOverall number of participants analyzed = number of participants with available data.Ratio of HDL-cholesterolGEOMETRIC_MEAN
SECONDARYChange in Triglycerides - Ratio to BaselineWeek 0, End of treatmentOverall number of participants analyzed = number of participants with available data.Ratio of triglyceridesGEOMETRIC_MEAN

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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