Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets - Tabular View

Tracking Information
First Received Date ^ICMJE	November 3, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00000102 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets
Official Title ^ICMJE
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).
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 Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind, Placebo Control, Parallel Assignment
Condition ^ICMJE	Congenital Adrenal Hyperplasia
Intervention ^ICMJE	Drug: Nifedipine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	14 Years to 35 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00000102
Responsible Party
Study ID Numbers ^ICMJE	NCRR-M01RR01070-0506, M01RR01070
Study Sponsor ^ICMJE	National Center for Research Resources (NCRR)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Center for Research Resources (NCRR)
Verification Date	January 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP