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Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets
This study has been completed.
Study NCT00000102   Information provided by National Center for Research Resources (NCRR)
First Received: November 3, 1999   Last Updated: June 23, 2005   History of Changes

November 3, 1999
June 23, 2005
 
 
 
 
Complete list of historical versions of study NCT00000102 on ClinicalTrials.gov Archive Site
 
 
 
Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets
 

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).

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.

Phase I, Phase II
Interventional
Treatment, Double-Blind, Placebo Control, Parallel Assignment
Congenital Adrenal Hyperplasia
Drug: Nifedipine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
14 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000102
 
NCRR-M01RR01070-0506, M01RR01070
National Center for Research Resources (NCRR)
 
 
National Center for Research Resources (NCRR)
January 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP