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Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets

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ClinicalTrials.gov Identifier: NCT00000102
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)

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

Resource links provided by the National Library of Medicine

Drug Information available for: Nifedipine

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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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
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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
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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    Key Record Dates
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