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History of Changes for Study: NCT00000102
Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets
Latest version (submitted June 23, 2005) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 23, 2005 None (earliest Version on record)
Comparison Format:

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Study NCT00000102
Submitted Date:  June 23, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: NCRR-M01RR01070-0506
Brief Title: Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets
Official Title:
Secondary IDs: M01RR001070 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: January 2004
Overall Status: Completed
Study Start:
Primary Completion:
Study Completion:
First Submitted: November 3, 1999
First Submitted that
Met QC Criteria:
November 3, 1999
First Posted: November 4, 1999 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 23, 2005
Last Update Posted: June 24, 2005 [Estimate]
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Sponsor: National Center for Research Resources (NCRR)
Responsible Party:
Collaborators:
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U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module 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.
Open or close this module Conditions
Conditions: Congenital Adrenal Hyperplasia
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Double (masked roles unspecified)
Enrollment:
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Intervention Details:
Drug: Nifedipine
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 14 Years
Maximum Age: 35 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Locations: United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States
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Plan to Share IPD:
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Citations:
Links:
Available IPD/Information:

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