Congenital Adrenal Hyperplasia
Conditions
Brief summary
This study will test the ability of extended release nifedipine (Procardia XL), a blood pressure medication, to permit a decrease in the dose of glucocorticoid medication children take to treat congenital adrenal hyperplasia (CAH).
Detailed description
This protocol is designed to assess both acute and chronic effects of the calcium channel antagonist, nifedipine, on the hypothalamic-pituitary-adrenal axis in patients with congenital adrenal hyperplasia. The multicenter trial is composed of two phases and will involve a double-blind, placebo-controlled parallel design. The goal of Phase I is to examine the ability of nifedipine vs. placebo to decrease adrenocorticotropic hormone (ACTH) levels, as well as to begin to assess the dose-dependency of nifedipine effects. The goal of Phase II is to evaluate the long-term effects of nifedipine; that is, can attenuation of ACTH release by nifedipine permit a decrease in the dosage of glucocorticoid needed to suppress the HPA axis? Such a decrease would, in turn, reduce the deleterious effects of glucocorticoid treatment in CAH.
Interventions
DRUGNifedipine
Sponsors
National Center for Research Resources (NCRR)
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
14 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed with Congenital Adrenal Hyperplasia (CAH) * normal ECG during baseline evaluation
Exclusion criteria
* history of liver disease, or elevated liver function tests * history of cardiovascular disease
Countries
United States
Outcome results
None listed