Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets - Full Text View

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Placebo Control, Parallel Assignment

Further study details as provided by National Center for Research Resources (NCRR):

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

Ages Eligible for Study:	14 Years to 35 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000102

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

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

Study placed in the following topic categories:

Metabolic Diseases

Gonadal Disorders

Adrenogenital Syndrome

Adrenal Gland Diseases

Endocrine System Diseases

Nifedipine

Metabolism, Inborn Errors

Hyperplasia

Adrenal hyperplasia

Genetic Diseases, Inborn

Adrenal Hyperplasia, Congenital

Endocrinopathy

Epinephrine

Metabolic disorder

Additional relevant MeSH terms:

Vasodilator Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Calcium Channel Blockers

Cardiovascular Agents

Reproductive Control Agents

Sex Differentiation Disorders

Pharmacologic Actions

Membrane Transport Modulators

Pathologic Processes

Tocolytic Agents

Therapeutic Uses

Steroid Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on December 03, 2008

Sponsored by:	National Center for Research Resources (NCRR)
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00000102