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Trial NCT00000102

Resource URI: http://static.linkedct.org/resource/trials/NCT00000102
linkedct:brief_title Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets
linkedct:condition <http://static.linkedct.org/resource/condition/3196>
linkedct: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
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 35 Years
linkedct:eligibility_minimum_age 14 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date November 3, 1999
linkedct:id NCT00000102
rdfs:label Trial NCT00000102
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Center for Research Resources (NCRR)
linkedct:location <http://static.linkedct.org/resource/location/144395>
linkedct:nct_id NCT00000102
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id NCRR-M01RR01070-0506
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000102>
linkedct:phase Phase 1/Phase 2
linkedct:secondary_id M01RR01070
linkedct:source National Center for Research Resources (NCRR)
linkedct:study_design Treatment, Double-Blind, Placebo Control, Parallel Assignment
linkedct:study_type Interventional
linkedct: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).
rdf:type linkedct:trials
linkedct:verification_date January 2004