Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Congenital Adrenal Hyperplasia	Drug: Nifedipine	Phase 1; Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	14 Years to 35 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States

Sponsors and Collaborators

National Center for Research Resources (NCRR)

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00000102 History of Changes
Other Study ID Numbers:	NCRR-M01RR01070-0506; M01RR001070 ( U.S. NIH Grant/Contract )
First Posted:	November 4, 1999
Last Update Posted:	June 24, 2005
Last Verified:	January 2004

Additional relevant MeSH terms:

Hyperplasia; Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Adrenocortical Hyperfunction; Pathologic Processes; Disorders of Sex Development; Urogenital Abnormalities; Congenital Abnormalities; Genetic Diseases, Inborn; Steroid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases	Adrenal Gland Diseases; Endocrine System Diseases; Gonadal Disorders; Nifedipine; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Tocolytic Agents; Reproductive Control Agents; Physiological Effects of Drugs