Trial Outcomes & Findings for Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAH (NCT NCT01735617)
NCT ID: NCT01735617
Last Updated: 2017-05-17
Results Overview
The maximum plasma concentration (Cmax) of chronocort
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
24 hours
Results posted on
2017-05-17
Participant Flow
Participant milestones
| Measure |
Hydrocortisone Modified Release Capsules
Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response
Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment
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|---|---|
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Overall Study
STARTED
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16
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Overall Study
COMPLETED
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16
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAH
Baseline characteristics by cohort
| Measure |
Hydrocortisone Modified Release Capsules
n=16 Participants
Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response
Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment
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Age, Continuous
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28.7 years
STANDARD_DEVIATION 12.97 • n=5 Participants
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Sex: Female, Male
Female
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8 Participants
n=5 Participants
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Sex: Female, Male
Male
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8 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
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Race (NIH/OMB)
White
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13 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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Region of Enrollment
United States
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16 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 24 hoursPopulation: All treated subjects
The maximum plasma concentration (Cmax) of chronocort
Outcome measures
| Measure |
Chronocort
n=16 Participants
Chronocort Modified Release Capsules 10 mg twice-daily.
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|---|---|
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Pharmacokinetic Profile (Cmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia
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601.213 nmol/L
Standard Deviation 114.5987
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PRIMARY outcome
Timeframe: 24 hours (at 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)Population: All treated subjects
Area under the curve (AUC) from 0 to 24 hours (sampling occurs at the following timepoints: 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)
Outcome measures
| Measure |
Chronocort
n=16 Participants
Chronocort Modified Release Capsules 10 mg twice-daily.
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|---|---|
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Pharmacokinetic Profile (AUC0-24) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia
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5027.641 h*nmol/L
Standard Deviation 1247.8425
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PRIMARY outcome
Timeframe: 24 hoursPopulation: All treated subjects
Time to maximum plasma concentration (tmax)
Outcome measures
| Measure |
Chronocort
n=16 Participants
Chronocort Modified Release Capsules 10 mg twice-daily.
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|---|---|
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Pharmacokinetic Profile (Tmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia
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7.9 Hours
Standard Deviation 2.9
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SECONDARY outcome
Timeframe: Specific time point (0700hrs)Proposed optimal ranges of 17-OHP: 300-1200ng/dl Proposed optimal ranges of androstenedione: 40-150ng.dl for males and 30-200ng/dl for females
Outcome measures
| Measure |
Chronocort
n=16 Participants
Chronocort Modified Release Capsules 10 mg twice-daily.
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|---|---|
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The Percentage of Patients With 17-OHP and Androstenedione Levels at 0700h Within Proposed Optimal Ranges Whilst on Chronocort and Whilst on Standard Therapy (at Baseline)
17-OHP (baseline)
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0 percentage of participants
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The Percentage of Patients With 17-OHP and Androstenedione Levels at 0700h Within Proposed Optimal Ranges Whilst on Chronocort and Whilst on Standard Therapy (at Baseline)
17-OHP (final visit)
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12.5 percentage of participants
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The Percentage of Patients With 17-OHP and Androstenedione Levels at 0700h Within Proposed Optimal Ranges Whilst on Chronocort and Whilst on Standard Therapy (at Baseline)
Androstenedione (baseline)
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56.3 percentage of participants
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The Percentage of Patients With 17-OHP and Androstenedione Levels at 0700h Within Proposed Optimal Ranges Whilst on Chronocort and Whilst on Standard Therapy (at Baseline)
Androstenedione (final visit)
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81.3 percentage of participants
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SECONDARY outcome
Timeframe: Specified time points (0700h, 1700h and 2300h)17-OHP levels at 0700h, 1700h and 2300h
Outcome measures
| Measure |
Chronocort
n=16 Participants
Chronocort Modified Release Capsules 10 mg twice-daily.
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|---|---|
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17-OHP Levels at 0700h, 1700h and 2300h
17-OHP: Part A, Days 1-2 (0700h)
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76.97 nmol/L
Standard Deviation 91.986
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17-OHP Levels at 0700h, 1700h and 2300h
17-OHP: Part A, Days 1-2 (1700h)
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70.99 nmol/L
Standard Deviation 104.106
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17-OHP Levels at 0700h, 1700h and 2300h
17-OHP: Part A, Days 1-2 (2300h)
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55.35 nmol/L
Standard Deviation 93.632
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17-OHP Levels at 0700h, 1700h and 2300h
17-OHP: Part A, Days 4-5 (0700h)
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7.72 nmol/L
Standard Deviation 8.231
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17-OHP Levels at 0700h, 1700h and 2300h
17-OHP: Part A, Days 4-5 (1700h)
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23.55 nmol/L
Standard Deviation 66.046
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17-OHP Levels at 0700h, 1700h and 2300h
17-OHP: Part A, Days 4-5 (2300h)
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27.27 nmol/L
Standard Deviation 55.140
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17-OHP Levels at 0700h, 1700h and 2300h
17-OHP: Part B, Visit 2 (0700h)
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24.86 nmol/L
Standard Deviation 54.086
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17-OHP Levels at 0700h, 1700h and 2300h
17-OHP: Part B, Visit 2 (1700h)
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15.17 nmol/L
Standard Deviation 20.400
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17-OHP Levels at 0700h, 1700h and 2300h
17-OHP: Part B, Visit 2 (2300h)
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26.65 nmol/L
Standard Deviation 51.185
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17-OHP Levels at 0700h, 1700h and 2300h
17-OHP: Part B, Visit 3 (0700h)
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34.87 nmol/L
Standard Deviation 49.072
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17-OHP Levels at 0700h, 1700h and 2300h
17-OHP: Part B, Visit 3 (1700h)
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13.81 nmol/L
Standard Deviation 20.700
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17-OHP Levels at 0700h, 1700h and 2300h
17-OHP: Part B, Visit 3 (2300h)
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18.95 nmol/L
Standard Deviation 28.276
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17-OHP Levels at 0700h, 1700h and 2300h
17-OHP: Part B, Visit 4 (0700h)
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13.67 nmol/L
Standard Deviation 19.091
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17-OHP Levels at 0700h, 1700h and 2300h
17-OHP: Part B, Visit 4 (1700h)
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34.70 nmol/L
Standard Deviation 69.876
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17-OHP Levels at 0700h, 1700h and 2300h
17-OHP: Part B, Visit 4 (2300h)
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22.19 nmol/L
Standard Deviation 46.826
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SECONDARY outcome
Timeframe: Specified time points (0700h, 1700h and 2300h)Androstenedione levels at 0700h, 1700h and 2300h
Outcome measures
| Measure |
Chronocort
n=16 Participants
Chronocort Modified Release Capsules 10 mg twice-daily.
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|---|---|
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Androstenedione Levels at 0700h, 1700h and 2300h
Androstenedione: Part A, Days 1-2 (0700h)
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7.92 nmol/L
Standard Deviation 8.474
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Androstenedione Levels at 0700h, 1700h and 2300h
Androstenedione: Part A, Days 1-2 (1700h)
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7.54 nmol/L
Standard Deviation 7.966
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Androstenedione Levels at 0700h, 1700h and 2300h
Androstenedione: Part A, Days 1-2 (2300h)
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7.43 nmol/L
Standard Deviation 9.388
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Androstenedione Levels at 0700h, 1700h and 2300h
Androstenedione: Part A, Days 4-5 (0700h)
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3.11 nmol/L
Standard Deviation 2.178
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Androstenedione Levels at 0700h, 1700h and 2300h
Androstenedione: Part A, Days 4-5 (1700h)
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4.62 nmol/L
Standard Deviation 8.005
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Androstenedione Levels at 0700h, 1700h and 2300h
Androstenedione: Part A, Days 4-5 (2300h)
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5.37 nmol/L
Standard Deviation 8.340
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Androstenedione Levels at 0700h, 1700h and 2300h
Androstenedione: Part B, Visit 2 (0700h)
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4.96 nmol/L
Standard Deviation 6.731
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Androstenedione Levels at 0700h, 1700h and 2300h
Androstenedione: Part B, Visit 2 (1700h)
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3.47 nmol/L
Standard Deviation 3.094
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Androstenedione Levels at 0700h, 1700h and 2300h
Androstenedione: Part B, Visit 2 (2300h)
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3.79 nmol/L
Standard Deviation 3.748
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Androstenedione Levels at 0700h, 1700h and 2300h
Androstenedione: Part B, Visit 3 (0700h)
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4.57 nmol/L
Standard Deviation 3.561
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Androstenedione Levels at 0700h, 1700h and 2300h
Androstenedione: Part B, Visit 3 (1700h)
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3.61 nmol/L
Standard Deviation 2.713
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Androstenedione Levels at 0700h, 1700h and 2300h
Androstenedione: Part B, Visit 3 (2300h)
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3.91 nmol/L
Standard Deviation 3.103
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Androstenedione Levels at 0700h, 1700h and 2300h
Androstenedione: Part B, Visit 4 (0700h)
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3.40 nmol/L
Standard Deviation 1.973
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Androstenedione Levels at 0700h, 1700h and 2300h
Androstenedione: Part B, Visit 4 (1700h)
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4.19 nmol/L
Standard Deviation 4.602
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Androstenedione Levels at 0700h, 1700h and 2300h
Androstenedione: Part B, Visit 4 (2300h)
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3.37 nmol/L
Standard Deviation 2.655
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SECONDARY outcome
Timeframe: Specified time points (0700h, 1700h and 2300h)ACTH levels at 0700h, 1700h and 2300h
Outcome measures
| Measure |
Chronocort
n=16 Participants
Chronocort Modified Release Capsules 10 mg twice-daily.
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|---|---|
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ACTH Levels at 0700h, 1700h and 2300h
ACTH: Part A, Days 1-2 (0700h)
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21.06 pmol/L
Standard Deviation 29.767
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ACTH Levels at 0700h, 1700h and 2300h
ACTH: Part A, Days 1-2 (1700h)
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20.93 pmol/L
Standard Deviation 30.121
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ACTH Levels at 0700h, 1700h and 2300h
ACTH: Part A, Days 1-2 (2300h)
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7.75 pmol/L
Standard Deviation 9.873
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ACTH Levels at 0700h, 1700h and 2300h
ACTH: Part A, Days 4-5 (0700h)
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4.16 pmol/L
Standard Deviation 9.190
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ACTH Levels at 0700h, 1700h and 2300h
ACTH: Part A, Days 4-5 (1700h)
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4.71 pmol/L
Standard Deviation 7.382
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ACTH Levels at 0700h, 1700h and 2300h
ACTH: Part A, Days 4-5 (2300h)
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7.37 pmol/L
Standard Deviation 7.990
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ACTH Levels at 0700h, 1700h and 2300h
ACTH: Part B, Visit 2 (0700h)
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7.02 pmol/L
Standard Deviation 12.159
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ACTH Levels at 0700h, 1700h and 2300h
ACTH: Part B, Visit 2 (1700h)
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5.57 pmol/L
Standard Deviation 6.769
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ACTH Levels at 0700h, 1700h and 2300h
ACTH: Part B, Visit 2 (2300h)
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8.66 pmol/L
Standard Deviation 14.637
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ACTH Levels at 0700h, 1700h and 2300h
ACTH: Part B, Visit 3 (0700h)
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9.66 pmol/L
Standard Deviation 12.418
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ACTH Levels at 0700h, 1700h and 2300h
ACTH: Part B, Visit 3 (1700h)
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4.71 pmol/L
Standard Deviation 6.331
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ACTH Levels at 0700h, 1700h and 2300h
ACTH: Part B, Visit 3 (2300h)
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6.04 pmol/L
Standard Deviation 7.997
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ACTH Levels at 0700h, 1700h and 2300h
ACTH: Part B, Visit 4 (0700h)
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12.18 pmol/L
Standard Deviation 29.911
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ACTH Levels at 0700h, 1700h and 2300h
ACTH: Part B, Visit 4 (1700h)
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13.66 pmol/L
Standard Deviation 22.851
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ACTH Levels at 0700h, 1700h and 2300h
ACTH: Part B, Visit 4 (2300h)
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9.44 pmol/L
Standard Deviation 17.474
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SECONDARY outcome
Timeframe: Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)AUC values (nmol\*h/L) for Androstenedione for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h
Outcome measures
| Measure |
Chronocort
n=16 Participants
Chronocort Modified Release Capsules 10 mg twice-daily.
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|---|---|
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AUC Values (Nmol*h/L) for Androstenedione
Androstenedione: Part A, Days 1-2 AUC (2300-2300h)
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166.19 nmol*h/L
Standard Deviation 171.969
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AUC Values (Nmol*h/L) for Androstenedione
Androstenedione: Part A, Days 1-2 AUC (2300-0700h)
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41.42 nmol*h/L
Standard Deviation 34.133
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AUC Values (Nmol*h/L) for Androstenedione
Androstenedione: Part A, Days 1-2 AUC (0700-1500h)
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65.33 nmol*h/L
Standard Deviation 76.337
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AUC Values (Nmol*h/L) for Androstenedione
Androstenedione: Part A, Days 1-2 AUC (1500-2300h)
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59.44 nmol*h/L
Standard Deviation 65.995
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AUC Values (Nmol*h/L) for Androstenedione
Androstenedione: Part A, Days 4-5 AUC (2300-2300h)
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104.37 nmol*h/L
Standard Deviation 128.725
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AUC Values (Nmol*h/L) for Androstenedione
Androstenedione: Part A, Days 4-5 AUC (2300-0700h)
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36.02 nmol*h/L
Standard Deviation 40.225
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AUC Values (Nmol*h/L) for Androstenedione
Androstenedione: Part A, Days 4-5 AUC (0700-1500h)
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32.01 nmol*h/L
Standard Deviation 31.503
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AUC Values (Nmol*h/L) for Androstenedione
Androstenedione: Part A, Days 4-5 AUC (1500-2300h)
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37.91 nmol*h/L
Standard Deviation 58.394
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AUC Values (Nmol*h/L) for Androstenedione
Androstenedione: Part B, Visit 2 AUC (2300-2300h)
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88.58 nmol*h/L
Standard Deviation 86.364
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AUC Values (Nmol*h/L) for Androstenedione
Androstenedione: Part B, Visit 2 AUC (2300-0700h)
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35.12 nmol*h/L
Standard Deviation 43.580
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AUC Values (Nmol*h/L) for Androstenedione
Androstenedione: Part B, Visit 2 AUC (0700-1500h)
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26.07 nmol*h/L
Standard Deviation 22.298
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AUC Values (Nmol*h/L) for Androstenedione
Androstenedione: Part B, Visit 2 AUC (1500-2300h)
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27.39 nmol*h/L
Standard Deviation 23.989
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AUC Values (Nmol*h/L) for Androstenedione
Androstenedione: Part B, Visit 3 AUC (2300-2300h)
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91.46 nmol*h/L
Standard Deviation 65.295
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AUC Values (Nmol*h/L) for Androstenedione
Androstenedione: Part B, Visit 3 AUC (2300-0700h)
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33.25 nmol*h/L
Standard Deviation 26.255
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AUC Values (Nmol*h/L) for Androstenedione
Androstenedione: Part B, Visit 3 AUC (0700-1500h)
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27.92 nmol*h/L
Standard Deviation 16.297
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AUC Values (Nmol*h/L) for Androstenedione
Androstenedione: Part B, Visit 3 AUC (1500-2300h)
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30.30 nmol*h/L
Standard Deviation 26.188
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AUC Values (Nmol*h/L) for Androstenedione
Androstenedione: Part B, Visit 4 AUC (2300-2300h)
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86.27 nmol*h/L
Standard Deviation 70.892
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AUC Values (Nmol*h/L) for Androstenedione
Androstenedione: Part B, Visit 4 AUC (2300-0700h)
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29.09 nmol*h/L
Standard Deviation 23.314
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AUC Values (Nmol*h/L) for Androstenedione
Androstenedione: Part B, Visit 4 AUC (0700-1500h)
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27.03 nmol*h/L
Standard Deviation 20.009
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AUC Values (Nmol*h/L) for Androstenedione
Androstenedione: Part B, Visit 4 AUC (1500-2300h)
|
30.13 nmol*h/L
Standard Deviation 28.797
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SECONDARY outcome
Timeframe: Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)AUC values (nmol\*h/L) for 17-OHP for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h
Outcome measures
| Measure |
Chronocort
n=16 Participants
Chronocort Modified Release Capsules 10 mg twice-daily.
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|---|---|
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AUC Values (Nmol*h/L) for 17-OHP
17-OHP: Part A, Days 1-2 AUC 2300-2300h
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1407.83 nmol*h/L
Standard Deviation 1829.291
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AUC Values (Nmol*h/L) for 17-OHP
17-OHP: Part A, Days 1-2 AUC 2300-0700h
|
243.99 nmol*h/L
Standard Deviation 339.580
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AUC Values (Nmol*h/L) for 17-OHP
17-OHP: Part A, Days 1-2 AUC 0700-1500h
|
607.74 nmol*h/L
Standard Deviation 805.822
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AUC Values (Nmol*h/L) for 17-OHP
17-OHP: Part A, Days 1-2 AUC 1500-2300h
|
556.11 nmol*h/L
Standard Deviation 769.492
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AUC Values (Nmol*h/L) for 17-OHP
17-OHP: Part A, Days 4-5 AUC 2300-2300h
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446.90 nmol*h/L
Standard Deviation 817.074
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AUC Values (Nmol*h/L) for 17-OHP
17-OHP: Part A, Days 4-5 AUC 2300-0700h
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169.83 nmol*h/L
Standard Deviation 268.178
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AUC Values (Nmol*h/L) for 17-OHP
17-OHP: Part A, Days 4-5 AUC 0700-1500h
|
91.53 nmol*h/L
Standard Deviation 147.801
|
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AUC Values (Nmol*h/L) for 17-OHP
17-OHP: Part A, Days 4-5 AUC 1500-2300h
|
190.73 nmol*h/L
Standard Deviation 425.505
|
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AUC Values (Nmol*h/L) for 17-OHP
17-OHP: Part B, Visit 2 AUC 2300-2300h
|
395.65 nmol*h/L
Standard Deviation 587.533
|
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AUC Values (Nmol*h/L) for 17-OHP
17-OHP: Part B, Visit 2 AUC 2300-0700h
|
168.01 nmol*h/L
Standard Deviation 337.666
|
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AUC Values (Nmol*h/L) for 17-OHP
17-OHP: Part B, Visit 2 AUC 0700-1500h
|
82.41 nmol*h/L
Standard Deviation 91.708
|
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AUC Values (Nmol*h/L) for 17-OHP
17-OHP: Part B, Visit 2 AUC 1500-2300h
|
145.24 nmol*h/L
Standard Deviation 215.115
|
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AUC Values (Nmol*h/L) for 17-OHP
17-OHP: Part B, Visit 3 AUC 2300-2300h
|
432.02 nmol*h/L
Standard Deviation 393.897
|
|
AUC Values (Nmol*h/L) for 17-OHP
17-OHP: Part B, Visit 3 AUC 2300-0700h
|
152.63 nmol*h/L
Standard Deviation 144.576
|
|
AUC Values (Nmol*h/L) for 17-OHP
17-OHP: Part B, Visit 3 AUC 0700-1500h
|
139.21 nmol*h/L
Standard Deviation 147.353
|
|
AUC Values (Nmol*h/L) for 17-OHP
17-OHP: Part B, Visit 3 AUC 1500-2300h
|
140.18 nmol*h/L
Standard Deviation 182.786
|
|
AUC Values (Nmol*h/L) for 17-OHP
17-OHP: Part B, Visit 4 AUC 2300-2300h
|
436.54 nmol*h/L
Standard Deviation 678.052
|
|
AUC Values (Nmol*h/L) for 17-OHP
17-OHP: Part B, Visit 4 AUC 2300-0700h
|
101.33 nmol*h/L
Standard Deviation 148.003
|
|
AUC Values (Nmol*h/L) for 17-OHP
17-OHP: Part B, Visit 4 AUC 0700-1500h
|
120.32 nmol*h/L
Standard Deviation 172.134
|
|
AUC Values (Nmol*h/L) for 17-OHP
17-OHP: Part B, Visit 4 AUC 1500-2300h
|
214.89 nmol*h/L
Standard Deviation 364.641
|
SECONDARY outcome
Timeframe: Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)AUC values (pmol\*h/L) for ACTH for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h
Outcome measures
| Measure |
Chronocort
n=16 Participants
Chronocort Modified Release Capsules 10 mg twice-daily.
|
|---|---|
|
AUC Values (Pmol*h/L) for ACTH
ACTH: Part A, Days 1-2 AUC (2300-2300h)
|
356.25 pmol*h/L
Standard Deviation 415.949
|
|
AUC Values (Pmol*h/L) for ACTH
ACTH: Part A, Days 1-2 AUC (2300-0700h)
|
54.72 pmol*h/L
Standard Deviation 70.267
|
|
AUC Values (Pmol*h/L) for ACTH
ACTH: Part A, Days 1-2 AUC (0700-1500h)
|
166.18 pmol*h/L
Standard Deviation 206.294
|
|
AUC Values (Pmol*h/L) for ACTH
ACTH: Part A, Days 1-2 AUC (1500-2300h)
|
135.35 pmol*h/L
Standard Deviation 169.002
|
|
AUC Values (Pmol*h/L) for ACTH
ACTH: Part A, Days 4-5 AUC (2300-2300h)
|
120.00 pmol*h/L
Standard Deviation 121.454
|
|
AUC Values (Pmol*h/L) for ACTH
ACTH: Part A, Days 4-5 AUC (2300-0700h)
|
52.22 pmol*h/L
Standard Deviation 62.067
|
|
AUC Values (Pmol*h/L) for ACTH
ACTH: Part A, Days 4-5 AUC (0700-1500h)
|
21.29 pmol*h/L
Standard Deviation 19.824
|
|
AUC Values (Pmol*h/L) for ACTH
ACTH: Part A, Days 4-5 AUC (1500-2300h)
|
47.13 pmol*h/L
Standard Deviation 57.145
|
|
AUC Values (Pmol*h/L) for ACTH
ACTH: Part B, Visit 2 AUC (2300-2300h)
|
125.45 pmol*h/L
Standard Deviation 118.081
|
|
AUC Values (Pmol*h/L) for ACTH
ACTH: Part B, Visit 2 AUC (2300-0700h)
|
43.09 pmol*h/L
Standard Deviation 46.711
|
|
AUC Values (Pmol*h/L) for ACTH
ACTH: Part B, Visit 2 AUC (0700-1500h)
|
34.14 pmol*h/L
Standard Deviation 48.423
|
|
AUC Values (Pmol*h/L) for ACTH
ACTH: Part B, Visit 2 AUC (1500-2300h)
|
48.22 pmol*h/L
Standard Deviation 49.078
|
|
AUC Values (Pmol*h/L) for ACTH
ACTH: Part B, Visit 3 AUC (2300-2300h)
|
154.10 pmol*h/L
Standard Deviation 172.474
|
|
AUC Values (Pmol*h/L) for ACTH
ACTH: Part B, Visit 3 AUC (2300-0700h)
|
50.02 pmol*h/L
Standard Deviation 57.268
|
|
AUC Values (Pmol*h/L) for ACTH
ACTH: Part B, Visit 3 AUC (0700-1500h)
|
52.46 pmol*h/L
Standard Deviation 64.571
|
|
AUC Values (Pmol*h/L) for ACTH
ACTH: Part B, Visit 3 AUC (1500-2300h)
|
51.63 pmol*h/L
Standard Deviation 70.735
|
|
AUC Values (Pmol*h/L) for ACTH
ACTH: Part B, Visit 4 AUC (2300-2300h)
|
252.30 pmol*h/L
Standard Deviation 420.220
|
|
AUC Values (Pmol*h/L) for ACTH
ACTH: Part B, Visit 4 AUC (2300-0700h)
|
58.80 pmol*h/L
Standard Deviation 107.955
|
|
AUC Values (Pmol*h/L) for ACTH
ACTH: Part B, Visit 4 AUC (0700-1500h)
|
110.58 pmol*h/L
Standard Deviation 329.386
|
|
AUC Values (Pmol*h/L) for ACTH
ACTH: Part B, Visit 4 AUC (1500-2300h)
|
82.92 pmol*h/L
Standard Deviation 120.287
|
Adverse Events
Hydrocortisone Modified Release Capsules
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hydrocortisone Modified Release Capsules
n=16 participants at risk
Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response
Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment
|
|---|---|
|
Nervous system disorders
Headache
|
81.2%
13/16 • Number of events 13 • Approximately 7 months
|
|
General disorders
Fatigue
|
81.2%
13/16 • Number of events 13 • Approximately 7 months
|
|
Blood and lymphatic system disorders
Anaemia
|
43.8%
7/16 • Number of events 9 • Approximately 7 months
|
|
Nervous system disorders
Dizziness
|
50.0%
8/16 • Number of events 8 • Approximately 7 months
|
|
Investigations
Weight increase
|
43.8%
7/16 • Number of events 7 • Approximately 7 months
|
|
Metabolism and nutrition disorders
Appetite decrease
|
43.8%
7/16 • Number of events 7 • Approximately 7 months
|
|
Metabolism and nutrition disorders
Appetite increase
|
37.5%
6/16 • Number of events 6 • Approximately 7 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
31.2%
5/16 • Number of events 5 • Approximately 7 months
|
|
Psychiatric disorders
Insomnia
|
31.2%
5/16 • Number of events 5 • Approximately 7 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
31.2%
5/16 • Number of events 5 • Approximately 7 months
|
|
General disorders
Asthenia
|
31.2%
5/16 • Number of events 5 • Approximately 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place