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NCT05063994 · ClinicalTrials.gov registry record · Phase 3
Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
A Phase 3 study, sponsored by Neurocrine UK Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 55
- Enrollment target
NCT05063994: Completed Phase 3 study, sponsored by Neurocrine UK Limited.
NCT05063994 is a Phase 3 study that has completed, run by Neurocrine UK Limited. The registered enrollment target is 55 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05063994, a Phase 3 study, has completed, sponsored by Neurocrine UK Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 55 participants
- Enrollment target
Study Summary
This study is a randomized, double-blind, active-controlled, phase III study of Chronocort® compared with immediate-release hydrocortisone replacement therapy in participants aged 16 years and over with Congenital Adrenal Hyperplasia.
Primary Outcome
Biochemical response was defined as a participant who a) was in biochemical control at the 08:00 assessment and b) was receiving a total daily dose of hydrocortisone of not more than 25 mg if the participant was in biochemical control at baseline or not more than 30 mg if the participant was not in biochemical control at baseline. Biochemical control was defined as both a 17-OHP concentration equal to or below the upper limit for optimal control (1200 ng/dL \[36.4 nmol/L\]) and an A4 concentrat
Interventions
- OTHER Placebo
- DRUG Chronocort
- DRUG Cortef
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2022-05-24 |
| Est. Completion | 2024-02-02 |
| Phase | Phase 3 |
What the finished NCT05063994 record still lists
NCT05063994 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05063994 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05063994 about?
NCT05063994 is a clinical study titled "Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia". This study is a randomized, double-blind, active-controlled, phase III study of Chronocort® compared with immediate-release hydrocortisone replacement therapy in participants aged 16 years and over with Congenital Adrenal Hyperplasia.
What is the current status of trial NCT05063994?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 55 participants. The study started on 2022-05-24. Estimated completion is 2024-02-02.
What interventions are being tested in trial NCT05063994?
The interventions under investigation include: Placebo (OTHER), Chronocort (DRUG), Cortef (DRUG).
Who is sponsoring clinical trial NCT05063994?
This trial is sponsored by Neurocrine UK Limited, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05063994's enrollment target sits among peer trials
55 1834th of 2000 higher than 163 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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