Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets
Information source: National Center for Research Resources (NCRR)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Congenital Adrenal Hyperplasia
Intervention: Nifedipine (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: National Center for Research Resources (NCRR)
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).
Clinical Details
Study design: Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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.
Eligibility
Minimum age: 14 Years.
Maximum age: 35 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Medical University of South Carolina, Charleston, South Carolina, United States
Additional Information
Last updated: June 23, 2005
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