Trial · NCT00915343
Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency
NCT00915343, Phase 2, Phase 3, Completed, Shire; results first posted 2015-07-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency. Trials, record NCT00915343. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00915343
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency
- NCT number
- NCT00915343
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 64 participants, actual
- Lead sponsor
- Shire
- Conditions
- Adrenal Insufficiency
- Interventions
- hydrocortisone (modified release), oral tablet 20 and 5 mg, Hydrocortisone, oral tablet, 10 mg
- First posted
- 2009-06-08
- Last updated
- 2020-11-24
- Other registries' IDs
- eudract:2006-007084-89
- Results first posted
- 2015-07-20
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Concentration Time Curve From Zero to 24 Hours (AUC0-24h) of Total S-cortisol in Plasma After Multiple Doses During Part A | Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days | AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The data for combined arm 1+2 after multiple doses were reported. |
| Secondary | Maximal Concentration (Cmax1) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. Cmax1 is the Cmax after first dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. |
| Secondary | Maximal Concentration (Cmax2) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. Cmax2 is the Cmax after second dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. |
| Secondary | Average Concentration of S-cortisol During the Dosing Interval at Steady State (Css,av) in Plasma After Single and Multiple Dosing During Part A | Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days | Css,av was calculated as the area under the S-cortisol concentration versus time curve during a dosing interval at steady state (AUCtau) divided by dosing interval (tau). Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. |
| Secondary | First Detectable Concentration (Cfirst) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days | Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. |
| Secondary | Concentration at 6 Hours (C6h) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days | Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. |
| Secondary | Concentration at 7 Hours (C7h) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days | Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. |
| Secondary | Time to Peak Plasma Concentration (Tmax1) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days | Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. Tmax1 is the Tmax after first dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. |
| Secondary | Time to Peak Plasma Concentration (Tmax2) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days | Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. Tmax2 is the Tmax after second dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. |
| Secondary | Time to First Detectable Concentration (Tfirst) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days | Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Concentration Time Curve From Zero to 24 Hours (AUC0-24h) of Total S-cortisol in Plasma After Multiple Doses During Part A | Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days | Part A: Intention-To-Treat (ITT) set included all randomised participants who took at least 1 dose of study drug with primary efficacy assessments including all pharmacokinetic (PK) samplings during either treatment period. Here number of participants analysed signifies those who were evaluable for the outcome measure. | hour*nanomole per liter | MEAN |
| SECONDARY | Maximal Concentration (Cmax1) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days | Part A ITT population with participants evaluable for this outcome. | nanomoles per liter | MEAN |
| SECONDARY | Maximal Concentration (Cmax2) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days | Part A ITT population with participants evaluable for this outcome. | nanomoles per liter | MEAN |
| SECONDARY | Average Concentration of S-cortisol During the Dosing Interval at Steady State (Css,av) in Plasma After Single and Multiple Dosing During Part A | Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days | Part A ITT population with participants evaluable for this outcome. | nanomoles per liter | MEAN |
| SECONDARY | First Detectable Concentration (Cfirst) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days | Part A ITT population with participants evaluable for this outcome. | nanomoles per liter | MEAN |
| SECONDARY | Concentration at 6 Hours (C6h) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days | Part A ITT population with participants evaluable for this outcome. | nanomoles per liter | MEAN |
| SECONDARY | Concentration at 7 Hours (C7h) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days | Part A ITT population with participants evaluable for this outcome. | nanomoles per liter | MEAN |
| SECONDARY | Time to Peak Plasma Concentration (Tmax1) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days | Part A ITT population with participants evaluable for this outcome. | hours | MEDIAN |
| SECONDARY | Time to Peak Plasma Concentration (Tmax2) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days | Part A ITT population with participants evaluable for this outcome. | hours | MEDIAN |
| SECONDARY | Time to First Detectable Concentration (Tfirst) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days | Part A ITT population with participants evaluable for this outcome. | hours | MEDIAN |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group114
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Concentration Time Curve From Zero to 24 Hours (AUC0-24h) of Total S-cortisol in Plasma After Multiple Doses During Part A | Hydrocortisone MR Tablet OD - Part A | 3962.0 | Standard Deviation 1079.6 | hour*nanomole per liter | |
| Area Under the Concentration Time Curve From Zero to 24 Hours (AUC0-24h) of Total S-cortisol in Plasma After Multiple Doses During Part A | Hydrocortisone Tablet TID - Part A | 4879.6 | Standard Deviation 1194.4 | hour*nanomole per liter | |
| Maximal Concentration (Cmax1) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Hydrocortisone MR Tablet OD - Part A | 690.7 | Standard Deviation 109.2 | nanomoles per liter | |
| Maximal Concentration (Cmax1) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Hydrocortisone Tablet TID - Part A | 802.8 | Standard Deviation 136.2 | nanomoles per liter | |
| Maximal Concentration (Cmax2) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Hydrocortisone MR Tablet OD - Part A | 553.8 | Standard Deviation 170.8 | nanomoles per liter | |
| Maximal Concentration (Cmax2) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Hydrocortisone Tablet TID - Part A | 446.9 | Standard Deviation 129.3 | nanomoles per liter | |
| Average Concentration of S-cortisol During the Dosing Interval at Steady State (Css,av) in Plasma After Single and Multiple Dosing During Part A | Hydrocortisone MR Tablet OD - Part A | 165.1 | Standard Deviation 45.0 | nanomoles per liter | |
| Average Concentration of S-cortisol During the Dosing Interval at Steady State (Css,av) in Plasma After Single and Multiple Dosing During Part A | Hydrocortisone Tablet TID - Part A | 203.3 | Standard Deviation 49.8 | nanomoles per liter | |
| First Detectable Concentration (Cfirst) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Hydrocortisone MR Tablet OD - Part A | 229.0 | Standard Deviation 169.8 | nanomoles per liter | |
| First Detectable Concentration (Cfirst) of S-cortisol in Plasma After Single and Multiple Dosing During Part A | Hydrocortisone Tablet TID - Part A | 295.1 | Standard Deviation 203.2 | nanomoles per liter |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A - First Intervention Period | STARTED | Hydrocortisone MR OD Then Hydrocortisone TID - Part A | 32 | |
| Part A - First Intervention Period | STARTED | Hydrocortisone TID Then Hydrocortisone MR OD - Part A | 32 | |
| Part A - First Intervention Period | STARTED | Hydrocortisone MR Tablet OD - Part B (All 6 Months) | 0 | |
| Part A - First Intervention Period | COMPLETED | Hydrocortisone MR OD Then Hydrocortisone TID - Part A | 32 | |
| Part A - First Intervention Period | COMPLETED | Hydrocortisone TID Then Hydrocortisone MR OD - Part A | 32 | |
| Part A - First Intervention Period | COMPLETED | Hydrocortisone MR Tablet OD - Part B (All 6 Months) | 0 | |
| Part A - First Intervention Period | NOT COMPLETED | Hydrocortisone MR OD Then Hydrocortisone TID - Part A | 0 | |
| Part A - First Intervention Period | NOT COMPLETED | Hydrocortisone TID Then Hydrocortisone MR OD - Part A | 0 | |
| Part A - First Intervention Period | NOT COMPLETED | Hydrocortisone MR Tablet OD - Part B (All 6 Months) | 0 | |
| Part A - Second Intervention Period | STARTED | Hydrocortisone MR OD Then Hydrocortisone TID - Part A | 32 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events75
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Hydrocortisone MR Tablet OD - Part A | 1 | 64 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Hydrocortisone Tablet TID - Part A | 0 | 64 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Hydrocortisone MR Tablet OD - Part B (First 3 Months) | 0 | 59 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Hydrocortisone MR Tablet OD - Part B (Second 3 Months) | 4 | 57 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Hydrocortisone MR Tablet OD - Part B (All 6 Months) | 4 | 59 | 5 |
| other | Fatigue | General disorders | Hydrocortisone MR Tablet OD - Part A | 8 | 64 | 10 |
| other | Fatigue | General disorders | Hydrocortisone Tablet TID - Part A | 3 | 64 | 3 |
| other | Fatigue | General disorders | Hydrocortisone MR Tablet OD - Part B (First 3 Months) | 4 | 59 | 4 |
| other | Fatigue | General disorders | Hydrocortisone MR Tablet OD - Part B (Second 3 Months) | 2 | 57 | 2 |
| other | Fatigue | General disorders | Hydrocortisone MR Tablet OD - Part B (All 6 Months) | 6 | 59 | 6 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hydrocortisone MR Tablet OD - Part A | ||
| Total, all-cause mortality | Hydrocortisone Tablet TID - Part A | ||
| Total, all-cause mortality | Hydrocortisone MR Tablet OD - Part B (First 3 Months) | ||
| Total, all-cause mortality | Hydrocortisone MR Tablet OD - Part B (Second 3 Months) | ||
| Total, all-cause mortality | Hydrocortisone MR Tablet OD - Part B (All 6 Months) | ||
| Total, other adverse events | Hydrocortisone MR Tablet OD - Part A | 29 | 64 |
| Total, other adverse events | Hydrocortisone Tablet TID - Part A | 25 | 64 |
| Total, other adverse events | Hydrocortisone MR Tablet OD - Part B (First 3 Months) | 12 | 59 |
| Total, other adverse events | Hydrocortisone MR Tablet OD - Part B (Second 3 Months) | 16 | 57 |
| Total, other adverse events | Hydrocortisone MR Tablet OD - Part B (All 6 Months) | 23 | 59 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers14
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT00915343/registered?page=2