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| Sponsored by: |
National Center for Research Resources (NCRR) |
| Information provided by: | National Center for Research Resources (NCRR) |
| ClinicalTrials.gov Identifier: | NCT00000102 |
Purpose
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).
| Condition | Intervention | Phase |
|
Congenital Adrenal Hyperplasia |
Drug: Nifedipine |
Phase I Phase II |
| Genetics Home Reference related topics: | 21-hydroxylase deficiency |
| Drug Information available for: | Nifedipine Calcium gluconate Epinephrine Epinephrine bitartrate |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Placebo Control, Parallel Assignment |
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
| Ages Eligible for Study: | 14 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | NCRR-M01RR01070-0506, M01RR01070 |
| First Received: | November 3, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000102 |
| Health Authority: | United States: Federal Government |
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