Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets

This study has been completed.

First Received: November 3, 1999 Last Updated: June 23, 2005 History of Changes

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: 21-hydroxylase deficiency

Drug Information available for: Nifedipine

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	NCRR-M01RR01070-0506, M01RR01070
Study First Received:	November 3, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000102 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Vasodilator Agents
Metabolic Diseases
Gonadal Disorders
Calcium Channel Blockers
Adrenogenital Syndrome
Adrenal Gland Diseases
Endocrine System Diseases
Cardiovascular Agents
Nifedipine
Adrenocortical Hyperfunction

Sex Differentiation Disorders
Calcium, Dietary
Metabolism, Inborn Errors
Hyperplasia
Genetic Diseases, Inborn
Adrenal Hyperplasia
Adrenal Hyperplasia, Congenital
Endocrinopathy
Epinephrine
Metabolic Disorder

Additional relevant MeSH terms:

Vasodilator Agents
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Physiological Effects of Drugs
Calcium Channel Blockers
Adrenogenital Syndrome
Adrenal Gland Diseases
Endocrine System Diseases
Reproductive Control Agents
Cardiovascular Agents
Nifedipine

Adrenocortical Hyperfunction
Sex Differentiation Disorders
Pharmacologic Actions
Membrane Transport Modulators
Metabolism, Inborn Errors
Hyperplasia
Pathologic Processes
Tocolytic Agents
Genetic Diseases, Inborn
Therapeutic Uses
Adrenal Hyperplasia, Congenital
Steroid Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on July 02, 2009