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NCT00000102 Clinical Trial

Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets

Congenital Adrenal Hyperplasia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000102
Other study ID # NCRR-M01RR01070-0506
Secondary ID M01RR001070
Status Completed
Phase Phase 1/Phase 2
First received November 3, 1999
Last updated June 23, 2005

Study information
Verified date January 2004
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 14 Years to 35 Years
Eligibility 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 Design

Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Nifedipine

Locations
Country Name City State
United States Medical University of South Carolina Charleston South Carolina

Sponsors (1)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
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Active, not recruiting NCT04544410 - A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAH Phase 2
Not yet recruiting NCT04087148 - Linear Growth of Children With Congenital Adrenal Hyperplasia
Completed NCT03162159 - Adult Height Prediction in Congenital Adrenal Hyperplasia
Recruiting NCT05687474 - Baby Detect : Genomic Newborn Screening
Enrolling by invitation NCT05162950 - Effects and Importance of Epinephrine/Adrenalin Deficiency in CAH
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Recruiting NCT04903587 - Gonadal Changes In Congenital Adrenal Hyperplasia Patients
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Active, not recruiting NCT04490915 - Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia Phase 3
Completed NCT01807364 - Cardiovascular Risk Profile in Patients With Congenital Adrenal Hyperplasia N/A
Completed NCT02804178 - A Study of ATR-101 for the Treatment of Congenital Adrenal Hyperplasia Phase 2
Completed NCT03019614 - An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone Phase 1
Not yet recruiting NCT04293133 - Final Height in Patients With CAH
Recruiting NCT03897504 - Surgical Evaluation of Using the Prepuce in Feminizing Genitoplasty N/A
Recruiting NCT05663320 - A Study of a Virtual Education-Based Transition Intervention to Improve Transition Readiness in Adolescent and Young Adults With Congenital Adrenal Hyperplasia N/A
Active, not recruiting NCT04806451 - Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study) Phase 3