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NCT02804750 · OUTCOME

Percentage of Participants With Hypertension Who Experience Improvement in Blood Pressure Following Treatment With CORT125134

Study to Evaluate CORT125134 in Participants With Cushing's Syndrome · Source last updated 2019-10-15

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Group 1: Week 12 or last observation; Group 2: Week 16 or last observation

What was measured

Improvement in blood pressure was defined as a participant who experiences at least a 5 mmHg decrease in mean diastolic or systolic BP from baseline who has not taken an additional antihypertensive medication during the treatment period or increased the dosage of a concurrent antihypertensive medication.

Analysis population: All enrolled participants with hypertension at Baseline who received at least one dose of study drug and had at least one post-baseline assessment.

Groups in this outcome

Group 1: Low-dose Group

100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.

Group 2: High-dose Group

250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. Period 4 was followed by a 4-week follow-up period.

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

Analysis denominator · Participants

GroupSource count
Group 1: Low-dose Group12
Group 2: High-dose Group11

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Group 1: Low-dose Group41.67Not reported15.1772.33Not reported
Group 2: High-dose Group63.64Not reported30.7989.07Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.17
        upper Limit
        72.33
        value
        41.67
      2. group Id
        OG001
        lower Limit
        30.79
        upper Limit
        89.07
        value
        63.64
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      11
    units
    Participants
description
Improvement in blood pressure was defined as a participant who experiences at least a 5 mmHg decrease in mean diastolic or systolic BP from baseline who has not taken an additional antihypertensive medication during the treatment period or increased the dosage of a concurrent antihypertensive medication.
dispersion Type
95% Confidence Interval
groups
  1. description
    100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
    id
    OG000
    title
    Group 1: Low-dose Group
  2. description
    250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. Period 4 was followed by a 4-week follow-up period.
    id
    OG001
    title
    Group 2: High-dose Group
param Type
NUMBER
population Description
All enrolled participants with hypertension at Baseline who received at least one dose of study drug and had at least one post-baseline assessment.
reporting Status
POSTED
time Frame
Group 1: Week 12 or last observation; Group 2: Week 16 or last observation
title
Percentage of Participants With Hypertension Who Experience Improvement in Blood Pressure Following Treatment With CORT125134
type
SECONDARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice