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NCT03697109 · OUTCOME

Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase.

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)

What was measured

Loss of response with respect to HTN was measured using 6 criteria: 1) an increase in SBP of at least 5 mm Hg, 2) an increase in DBP of at least 5 mm Hg, 3) an increase in SBP and/or DBP of at least 5 mm Hg, 4) use of HTN rescue medication, 5) treatment discontinuation, and 6) missing 24-hour ambulatory blood pressure monitoring (ABPM) measurement at the end of the RW Phase. Blood pressure was measured using ABPM. Use of rescue medication was defined as any increase, modification, or addition of antihypertensive medication due to worsening HTN. Treatment discontinuation reports the number of patients who discontinued study treatment in the RW Phase for any reason.

Analysis population: The analysis population was patients in the Intent-to-Treat (ITT-RW) Population who met the HTN response criteria at conclusion of the OL Phase. The ITT-RW Population included all patients who were randomized in the RW Phase and received at least 1 dose of study drug post randomization.

Groups in this outcome

Relacorilant (RW Phase)

Patients who meet any of the response criteria will advance to the RW Phase of the study and receive the same dose of relacorilant as the last dose administered in the OL Phase. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.

Placebo (RW Phase)

Patients who meet any of the response criteria will advance to the RW Phase of the study and receive placebo matched to study drug. Placebo: Placebo matched to study drug.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Relacorilant (RW Phase)21
Placebo (RW Phase)22

Reported measurements

SBP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Relacorilant (RW Phase)3Not reportedNot reportedNot reportedNot reported
Placebo (RW Phase)1Not reportedNot reportedNot reportedNot reported
DBP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Relacorilant (RW Phase)1Not reportedNot reportedNot reportedNot reported
Placebo (RW Phase)1Not reportedNot reportedNot reportedNot reported
SBP and/or DBP
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Relacorilant (RW Phase)3Not reportedNot reportedNot reportedNot reported
Placebo (RW Phase)4Not reportedNot reportedNot reportedNot reported
Use of rescue medication
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Relacorilant (RW Phase)0Not reportedNot reportedNot reportedNot reported
Placebo (RW Phase)7Not reportedNot reportedNot reportedNot reported
Treatment discontinuation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Relacorilant (RW Phase)2Not reportedNot reportedNot reportedNot reported
Placebo (RW Phase)3Not reportedNot reportedNot reportedNot reported
Missing ABPM at end of RW Phase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Relacorilant (RW Phase)2Not reportedNot reportedNot reportedNot reported
Placebo (RW Phase)3Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.04
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.77
    estimate Comment
    An odds ratio (OR) \<1 represents lower odds of loss of response under treatment with relacorilant compared with treatment with placebo.
    group Description
    A logistic regression model with logit link function was used in order to detect if there was a significant difference in total number of patients with a loss of response with respect to HTN under treatment with relacorilant compared with treatment with placebo in the RW Phase.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Log odds is equal to 0 (null hypothesis) vs log odds not equal to 0 (alternative hypothesis).
    non Inferiority Type
    EQUIVALENCE
    p Value
    0.0215
    param Type
    Odds Ratio (OR)
    param Value
    0.17
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. ci Lower Limit
    0.04
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.77
    estimate Comment
    An odds ratio (OR) \<1 represents lower odds of loss of response under treatment with relacorilant compared with treatment with placebo.
    group Description
    A logistic regression model with logit link function was used in order to detect if there was a significant difference in total number of patients with a loss of response with respect to HTN under treatment with relacorilant compared with treatment with placebo in the RW Phase.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Log odds is equal to 0 (null hypothesis) vs log odds not equal to 0 (alternative hypothesis).
    non Inferiority Type
    EQUIVALENCE
    p Value
    0.0215
    param Type
    Odds Ratio (OR)
    param Value
    0.17
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
    title
    SBP
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    DBP
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
    title
    SBP and/or DBP
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        7
    title
    Use of rescue medication
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
    title
    Treatment discontinuation
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
    title
    Missing ABPM at end of RW Phase
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      22
    units
    Participants
description
Loss of response with respect to HTN was measured using 6 criteria: 1) an increase in SBP of at least 5 mm Hg, 2) an increase in DBP of at least 5 mm Hg, 3) an increase in SBP and/or DBP of at least 5 mm Hg, 4) use of HTN rescue medication, 5) treatment discontinuation, and 6) missing 24-hour ambulatory blood pressure monitoring (ABPM) measurement at the end of the RW Phase. Blood pressure was measured using ABPM. Use of rescue medication was defined as any increase, modification, or addition of antihypertensive medication due to worsening HTN. Treatment discontinuation reports the number of patients who discontinued study treatment in the RW Phase for any reason.
groups
  1. description
    Patients who meet any of the response criteria will advance to the RW Phase of the study and receive the same dose of relacorilant as the last dose administered in the OL Phase. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.
    id
    OG000
    title
    Relacorilant (RW Phase)
  2. description
    Patients who meet any of the response criteria will advance to the RW Phase of the study and receive placebo matched to study drug. Placebo: Placebo matched to study drug.
    id
    OG001
    title
    Placebo (RW Phase)
param Type
COUNT_OF_PARTICIPANTS
population Description
The analysis population was patients in the Intent-to-Treat (ITT-RW) Population who met the HTN response criteria at conclusion of the OL Phase. The ITT-RW Population included all patients who were randomized in the RW Phase and received at least 1 dose of study drug post randomization.
reporting Status
POSTED
time Frame
Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
title
Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase.
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice