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

Sponsor:	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:	Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: 21-hydroxylase deficiency 3-beta-hydroxysteroid dehydrogenase deficiency congenital adrenal hyperplasia due to 11-beta-hydroxylase deficiency persistent Müllerian duct syndrome

MedlinePlus related topics: Calcium

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

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

Additional relevant MeSH terms:

Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Adrenocortical Hyperfunction
Hyperplasia
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
Pathologic Processes
Nifedipine
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on February 13, 2012