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Trial · NCT01760187

Outcomes27

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYCmax for Lomitapide1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7All subjects with evaluable concentrationsng/mLMEAN
PRIMARYTmax for Lomitapide1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7All subjects with evaluable concentrationshrMEDIAN
PRIMARYAUC0-t for Lomitapide1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7All subjects with evaluable concentrationsng*hr/mLMEAN
PRIMARYAUC0-∞ for Lomitapide1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7AUC0-∞ and t1/2 were not calculated for 3 subjects in the Japanese 10mg arm because the estimated t1/2 was being much longer than half of the total sampling time.ng*hr/mLMEAN
PRIMARYt1/2 for Lomitapide1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7AUC0-∞ and t1/2 were not calculated for 3 subjects in the Japanese 10mg arm because the estimated t1/2 was being much longer than half of the total sampling time.hrMEAN
PRIMARYCmax for Lomitapide1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27All subjects with evaluable concentrationsng/mLMEAN
PRIMARYTmax for Lomitapide1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27All subjects with evaluable concentrationshrMEDIAN
PRIMARYAUC0-t for Lomitapide1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27All subjects with evaluable concentrationsng*hr/mLMEAN
PRIMARYt1/2 for Lomitapide1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27All subjects with evaluable concentrationshrMEAN
SECONDARYCmax for M11, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7All subjects with evaluable concentrationsng/mLMEAN
SECONDARYTmax for M11, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7All subjects with evaluable concentrationshrMEDIAN
SECONDARYAUC0-t for M11, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7All subjects with evaluable concentrationsng*hr/mLMEAN
SECONDARYAUC0-∞ for M11, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7All subjects with evaluable concentrationsng*hr/mLMEAN
SECONDARYt1/2 for M11, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7All subjects with evaluable concentrationshrMEAN
SECONDARYCmax for M31, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7All subjects with evaluable concentrationsng/mLMEAN
SECONDARYTmax for M31, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7All subjects with evaluable concentrationshrMEDIAN
SECONDARYAUC0-t for M31, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7All subjects with evaluable concentrationsng*hr/mLMEAN
SECONDARYAUC0-∞ for M31, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7All subjects with evaluable concentrationsng*hr/mLMEAN
SECONDARYt1/2 for M31, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7All subjects with evaluable concentrationshrMEAN
SECONDARYCmax for M11, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27All subjects with evaluable concentrationsng/mLMEAN

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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