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Trial · NCT02642159

Registered outcomes23

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPercent Change From Baseline in Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) AnalysisFrom Baseline to Week 24
Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
PrimaryPercent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate StratumFrom Baseline to Week 24
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.
SecondaryPercent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall ITT AnalysisFrom Baseline to Week 24
Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.
SecondaryPercent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate StratumFrom Baseline to Week 24
Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.
SecondaryPercent Change From Baseline in Non-HDL-C at Week 12: Overall ITT AnalysisFrom Baseline to Week 24Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.
SecondaryPercent Change From Baseline in Non-HDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate StratumFrom Baseline to Week 24
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.
SecondaryPercent Change From Baseline in Measured LDL-C at Week 12: Overall ITT AnalysisFrom Baseline to Week 24
Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.
SecondaryPercent Change From Baseline in Measured LDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate StratumFrom Baseline to Week 24
Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.
SecondaryPercent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24: Overall ITT AnalysisFrom Baseline to Week 24Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.
SecondaryPercent Change From Baseline in Apo B at Week 24: ITT- Intent to Prescribe Fenofibrate StratumFrom Baseline to Week 24
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.
SecondaryPercent Change From Baseline in Total Cholesterol (Total-C) at Week 24 : Overall ITT AnalysisFrom Baseline to Week 24Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.
SecondaryPercent Change From Baseline in Total-C at Week 24: ITT- Intent to Prescribe Fenofibrate StratumFrom Baseline to Week 24
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.
SecondaryPercent Change From Baseline in Lipoprotein(a) at Week 24 : Overall ITT AnalysisFrom Baseline to Week 24
Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment were included in the imputation model.
SecondaryPercent Change From Baseline in Lipoprotein(a) at Week 24: ITT- Intent to Prescribe Fenofibrate StratumFrom Baseline to Week 24
Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.
SecondaryPercent Change From Baseline in Fasting Triglycerides at Week 24: Overall ITT AnalysisFrom Baseline to Week 24
Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.
SecondaryPercent Change From Baseline in Fasting Triglycerides at Week 24: ITT- Intent to Prescribe Fenofibrate StratumFrom Baseline to Week 24
Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.
SecondaryPercent Change From Baseline in HDL-C at Week 24 : Overall ITT AnalysisFrom Baseline to Week 24Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.
SecondaryPercent Change From Baseline in HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate StratumFrom Baseline to Week 24
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.
SecondaryPercent Change From Baseline in LDL-C Particle Number at Week 24: Overall ITT AnalysisFrom Baseline to Week 24
LDL-C particle number was calculated from lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.
SecondaryPercent Change From Baseline in LDL-C Particle Number at Week 24: ITT- Intent to Prescribe Fenofibrate StratumFrom Baseline to Week 24
LDL-C particle number was calculated from lipid subfractions by NMR spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

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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