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Congenital adrenal hyperplasia: Calcium channels as therapeutic targets



Congenital adrenal hyperplasia: Calcium channels as therapeutic targets

For Condition: Congenital Adrenal Hyperplasia
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) ,
Synopsis: 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).
Details: 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:
Study Type:  Interventional, Treatment, Double-Blind, Placebo Control, Parallel Assignment
Minimum Age/Maximum Age: 14 Years/35 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Medical University of South Carolina
Charleston,  South Carolina, 
United States
 


Additional Information:
Study ID Numbers:  NCRR-M01RR01070-0506;  M01RR01070
Study Start Date: 
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000102

Other Congenital Adrenal Hyperplasia Studies:
1. Three Drug Combination Therapy versus Conventional Treatment of Children with Congenital Adrenal Hyperplasia

2. Catecholamine Reserve and Exercise Tolerance in Healthy Volunteers and Patients with Congenital Adrenal Hyperplasia

3. Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Children

4. Congenital adrenal hyperplasia: Calcium channels as therapeutic targets

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