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Trial · NCT01865812

Registered outcomes56

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

ListOutcomeTime frameDescription
PrimaryAbsolute Change From Baseline In High-density Lipoprotein (HDL) Cholesterol ConcentrationBaseline, Week 8
PrimaryAbsolute Change From Baseline In HDL Particle SizeBaseline, Week 8
PrimaryAbsolute Change From Baseline In HDL Particle NumberBaseline, Week 8
SecondaryMedian Change From Baseline In HDL Cholesterol Concentration At Weeks 4, 8, and 12Baseline, Week 4, Week 8, Week 12
SecondaryMedian Change From Baseline In HDL Particle Size At Weeks 4, 8, and 12Baseline, Week 4, Week 8, Week 12
SecondaryMedian Change From Baseline In HDL Particle Number At Weeks 4, 8, and 12Baseline, Week 4, Week 8, Week 12
SecondaryMedian Change From Week 8 In HDL Cholesterol Concentration At Week 12Week 8, Week 12
SecondaryMedian Change From Week 8 In HDL Particle Size At Week 12Week 8, Week 12
SecondaryMedian Change From Week 8 In HDL Particle Number At Week 12Week 8, Week 12
SecondaryMaximum Plasma Concentration (Cmax) Of OCA And ConjugatesWeek 8Results are reported in nanograms per milliliter (ng/mL).
SecondaryTime To Reach Cmax (Tmax) For OCA And ConjugatesWeek 8Results are reported in hours (h).
SecondaryArea Under The Concentration-time Curve From Hour 0 To Last Sampling Time (Hour 6) (AUC0-6) For OCA And ConjugatesWeek 8Results are reported in hour\*nanograms per milliliter (h\*ng/mL).
SecondaryMedian Change From Baseline In Total CholesterolBaseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose
SecondaryMedian Change From Baseline In Total TriglyceridesBaseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose
SecondaryMedian Change From Baseline In Low-density Lipoprotein (LDL) Cholesterol (Direct)Baseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose
SecondaryMedian Change From Baseline In LDL Particle SizeBaseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose
SecondaryMedian Change From Baseline In Total LDL ParticlesBaseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last DoseResults are reported in nanomoles per liter (nmol/L).
SecondaryMedian Change From Baseline In Very Low-density Lipoprotein (VLDL) CholesterolBaseline, Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last DoseResults are reported in milligrams per deciliter (mg/dL).
SecondaryMedian Change From Baseline In VLDL Particle SizeBaseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose
SecondaryMedian Change From Baseline In VLDL ParticlesBaseline, Week 4, Week 8/End of Treatment (EOT), Week 12, Month 6, Month 12, Month 18, Month 24/EOT, Last Dose

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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