81. Congenital adrenal hyperplasia Clinical trials / Disease details


Clinical trials : 88 Drugs : 90 - (DrugBank : 23) / Drug target genes : 12 - Drug target pathways : 68

  
1 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-000711-40-DE
(EUCTR)
23/05/201606/10/2015Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness.A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Chronocort® 5 mg
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Product Name: Hydrocortisone 10mg Tablet
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Product Name: Dexamethasone 0.5mg Tablet
INN or Proposed INN: DEXAMETHASONE
Product Name: Prednisolone 5mg Tablet
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE
Product Name: Chronocort® 10 mg
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Product Name: Chronocort® 20 mg
Diurnal LtdNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden