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NCT03697109 · BASELINE

Baseline characteristics

A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome · Source last updated 2025-07-16

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      152
    units
    Participants
groups
  1. description
    Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.
    id
    BG000
    title
    Relacorilant (OL Phase)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.23
          value
          50.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          127
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          25
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          123
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          18
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          121
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          6
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          6
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          24.660
          value
          93.77
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body weight
    unit Of Measure
    kg
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          32.675
          value
          34.738
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index (BMI)
    unit Of Measure
    kg/m^2
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          18.0355
          value
          114.85
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Waist circumference
    unit Of Measure
    cm
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          31
    description
    HTN is defined as mean systolic blood pressure (SBP) ≥135 or ≤170 mm Hg and/or mean diastolic blood pressure (DBP) ≥85 to ≤110 mm Hg.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hypertension (HTN) only
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          50
    description
    DM is defined as fasting plasma glucose ≥126 mg/dL and/or oral glucose tolerance test plasma glucose ≥200 mg/dL or hemoglobin A1c (HbA1c) ≥6.5%. IGT is defined as plasma glucose ≥140 mg/dL and \<200 mg/dL on a 2-hour oral glucose tolerance test.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Diabetes mellitus (DM) or impaired glucose tolerance (IGT) only
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          71
    description
    HTN and DM/IGT as previously defined.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    HTN and DM/IGT
    unit Of Measure
    Participants
population Description
The analysis population was patients in the Intent-to-Treat (ITT) Population which included all enrolled patients who received at least 1 dose of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      152
    units
    Participants
groups
  1. description
    Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.
    id
    BG000
    title
    Relacorilant (OL Phase)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.23
          value
          50.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          127
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          25
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          123
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          18
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          121
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          6
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          6
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          24.660
          value
          93.77
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body weight
    unit Of Measure
    kg
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          32.675
          value
          34.738
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index (BMI)
    unit Of Measure
    kg/m^2
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          18.0355
          value
          114.85
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Waist circumference
    unit Of Measure
    cm
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          31
    description
    HTN is defined as mean systolic blood pressure (SBP) ≥135 or ≤170 mm Hg and/or mean diastolic blood pressure (DBP) ≥85 to ≤110 mm Hg.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hypertension (HTN) only
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          50
    description
    DM is defined as fasting plasma glucose ≥126 mg/dL and/or oral glucose tolerance test plasma glucose ≥200 mg/dL or hemoglobin A1c (HbA1c) ≥6.5%. IGT is defined as plasma glucose ≥140 mg/dL and \<200 mg/dL on a 2-hour oral glucose tolerance test.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Diabetes mellitus (DM) or impaired glucose tolerance (IGT) only
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          71
    description
    HTN and DM/IGT as previously defined.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    HTN and DM/IGT
    unit Of Measure
    Participants
population Description
The analysis population was patients in the Intent-to-Treat (ITT) Population which included all enrolled patients who received at least 1 dose of study drug.

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Preserved source evidence · Not medical advice