Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00000102

First Posted: November 4, 1999

Last Update Posted: December 9, 2005

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

National Center for Research Resources (NCRR)

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 1 Phase 2


Study Type:	Interventional
Study Design:	Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: 17 alpha-hydroxylase/17,20-lyase deficiency 21-hydroxylase deficiency 3-beta-hydroxysteroid dehydrogenase deficiency congenital adrenal hyperplasia due to 11-beta-hydroxylase deficiency

Drug Information available for: Nifedipine

Genetic and Rare Diseases Information Center resources: 21-hydroxylase Deficiency Congenital Adrenal Hyperplasia Hyperadrenalism

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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


ClinicalTrials.gov Identifier:	NCT00000102 History of Changes
Other Study ID Numbers:	NCRR-M01RR01070-0506 M01RR001070 ( U.S. NIH Grant/Contract )
First Submitted:	November 3, 1999
First Posted:	November 4, 1999
Last Update Posted:	December 9, 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

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