Trial record 21 of 107 for: "21-hydroxylase deficiency"
Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia
|ClinicalTrials.gov Identifier: NCT02716818|
Recruitment Status : Completed
First Posted : March 23, 2016
Results First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Information provided by (Responsible Party):
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment|
Congenital Adrenal Hyperplasia
Drug: standard glucocorticoid therapy
|Recruitment Details||This study was conducted at 11 study sites in 7 countries: Denmark 1, France 2, Germany 1,Netherlands 1, Sweden 1, UK 4, and USA 1.|
|Pre-assignment Details||Following written informed consent and screening tests (Visit 0), eligible participants were called back for the baseline visit. As part of the baseline assessment, participants were admitted overnight for a 24- hour endocrine profile whilst remaining on their standard therapy. Participants were then randomised to Chronocort or standard therapy.|
A limitation of the pre-defined primary endpoint was that it included an unsigned SDS score over a 24-hour period.