Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets



Sponsors


Source

National Center for Research Resources (NCRR)

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.

Overall Status

Completed

Start Date

N/A

Completion Date

N/A

Primary Completion Date

N/A

Phase

Phase 1/Phase 2

Study Type

Interventional


Condition


Intervention

Intervention Type

Drug

Intervention Name



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

Gender

All

Minimum Age

14 Years

Maximum Age

35 Years

Healthy Volunteers

No


Location

Facility

Medical University of South Carolina
Charleston South Carolina United States

Location Countries

Country

United States


Verification Date

2004-01-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Has Expanded Access

No

Condition Browse


Secondary Id

M01RR001070

Intervention Browse

Mesh Term

Nifedipine


Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

Double


Study First Submitted

November 3, 1999

Study First Submitted Qc

November 3, 1999

Study First Posted

November 4, 1999

Last Update Submitted

June 23, 2005

Last Update Submitted Qc

June 23, 2005

Last Update Posted

June 24, 2005


ClinicalTrials.gov processed this data on August 24, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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