Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets
Primary Purpose
Congenital Adrenal Hyperplasia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nifedipine
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Adrenal Hyperplasia
Eligibility 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
Sites / Locations
- Medical University of South Carolina
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000102
First Posted
November 3, 1999
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT00000102
Brief Title
Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets
Study Type
Interventional
2. Study Status
Record Verification Date
January 2004
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Adrenal Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nifedipine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
Country
United States
12. IPD Sharing Statement
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Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets
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