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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
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Adrenal Hyperplasia

Eligibility Criteria

14 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 3, 1999
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
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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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