- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000102
Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets
June 23, 2005 updated by: National Center for Research Resources (NCRR)
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Carolina
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Charleston, South Carolina, United States
- Medical University of South Carolina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 35 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 3, 1999
First Submitted That Met QC Criteria
November 3, 1999
First Posted (Estimate)
November 4, 1999
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
January 1, 2004
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Endocrine System Diseases
- Gonadal Disorders
- Disorders of Sex Development
- Urogenital Abnormalities
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Metabolism, Inborn Errors
- Adrenal Gland Diseases
- Steroid Metabolism, Inborn Errors
- Hyperplasia
- Adrenal Hyperplasia, Congenital
- Adrenogenital Syndrome
- Adrenocortical Hyperfunction
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Nifedipine
Other Study ID Numbers
- NCRR-M01RR01070-0506
- M01RR001070 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Congenital Adrenal Hyperplasia
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National Institutes of Health Clinical Center (CC)Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedAdrenal Insufficiency | Congenital Adrenal Hyperplasia (CAH) | Excess AndrogenUnited States
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Neurocrine BiosciencesCompletedCAH - Congenital Adrenal HyperplasiaUnited States
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Spruce BiosciencesCompletedCongenital Adrenal Hyperplasia | CAH - Congenital Adrenal HyperplasiaUnited States
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Neurocrine BiosciencesCompletedCAH - Congenital Adrenal HyperplasiaUnited States
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Spruce BiosciencesCompletedCongenital Adrenal Hyperplasia | CAH - Congenital Adrenal Hyperplasia | CAH - 21-Hydroxylase DeficiencyUnited States
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Assistance Publique - Hôpitaux de ParisCompletedCongenital Adrenal Hyperplasia (CAH)France
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Crinetics Pharmaceuticals Inc.RecruitingCongenital Adrenal Hyperplasia | Classic Congenital Adrenal HyperplasiaBrazil, United States, Argentina, Italy, United Kingdom
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Eunice Kennedy Shriver National Institute of Child...Active, not recruitingCongenital Adrenal Hyperplasia (CAH)United States
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Hospices Civils de LyonCompletedClassic Congenital Adrenal HyperplasiaFrance
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Diurnal LimitedNational Institutes of Health (NIH)CompletedCongenital Adrenal Hyperplasia | Adrenal Insufficiency | Endocrine DiseaseUnited States
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