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Corticosteroid
Hydrocortisone for Congenital Adrenal Hyperplasia
Phase 3
Waitlist Available
Led By Debbie Merke, MD
Research Sponsored by Diurnal Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with CAH who have successfully completed a clinical trial with the current formulation of Chronocort®.
Provision of signed written informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5.5 years
Awards & highlights
Study Summary
This trial is for people with Chronocort® therapy or glucocorticoid therapy to see if they want to continue with their current treatment or switch to Chronocort®.
Eligible Conditions
- Congenital Adrenal Hyperplasia
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability of Chronocort over time, as assessed by signs and symptoms of adrenal insufficiency.
Safety and tolerability of Chronocort, as assessed by change from pre-Chronocort® baseline in safety laboratory assessments.
Safety and tolerability of Chronocort, as assessed by change from pre-Chronocort® baseline in vital signs, weight, body mass index (BMI) and waist circumference.
+3 moreSecondary outcome measures
Long-term efficacy of Chronocort, as assessed by change from pre-Chronocort baseline in SDS of A4.
Long-term efficacy of Chronocort, as assessed by change from pre-Chronocort baseline in Standarad Deviation Score (SDS) of 17-OHP.
Long-term efficacy of Chronocort, as assessed by change from pre-Chronocort baseline in absolute values of 17-OHP.
+11 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Chronocort®Experimental Treatment1 Intervention
Chronocort® modified release hydrocortisone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydrocortisone
2005
Completed Phase 4
~1260
Find a Location
Who is running the clinical trial?
Diurnal LimitedLead Sponsor
18 Previous Clinical Trials
729 Total Patients Enrolled
Debbie Merke, MDPrincipal InvestigatorNational Institutes of Health (NIH)
1 Previous Clinical Trials
122 Total Patients Enrolled
Frequently Asked Questions
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