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Trial · NCT00093015

Outcomes11

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARY
Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)
Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred firstThe analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.ParticipantsNUMBER
PRIMARYTime to All-cause Mortality or End Stage Renal Disease (ESRD)Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred firstThe analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.ParticipantsNUMBER
SECONDARYTime to All-cause MortalityUntil a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred firstThe analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.ParticipantsNUMBER
SECONDARYTime to Cardiovascular MortalityUntil a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred firstThe analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.ParticipantsNUMBER
SECONDARYTime to Myocardial InfarctionUntil a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred firstThe analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.ParticipantsNUMBER
SECONDARYTime to Cerebrovascular AccidentUntil a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred firstThe analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.ParticipantsNUMBER
SECONDARYTime to Congestive Heart FailureUntil a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred firstThe analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.ParticipantsNUMBER
SECONDARYTime to End Stage Renal DiseaseUntil a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred firstThe analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.ParticipantsNUMBER
SECONDARYRate of Decline in Estimated Glomerular Filtration Rate (eGFR) Relative to BaselineUntil a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first
Subjects were analyzed as randomized using all available eGFR measurements, except eGFR measurements measured after subjects develop ESRD since creatinine measurements were no longer reliable or meaningful for eGFR calculation.
mL/min/1.73m^2MEAN
SECONDARYChange in Patient Reported Fatigue Relative to Baseline at Week 25Baseline and week 25
Subjects with both the baseline and at least post-baseline measurement at week 25 for FACT-fatigue were included in the analysis and were analyzed as randomized. Last observation carried forward (LOCF) using last non-missing post-baseline value was used for missing post-baseline data for subjects who were still on study.
Units on a scaleMEAN
SECONDARYTime to Hospitalization Due to Acute Myocardial IschemiaUntil a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred firstThe analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.ParticipantsNUMBER

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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