Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000102
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-03
Brief Title:
Congenital Adrenal Hyperplasia Calcium Channels as Therapeutic Targets
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| M01RR001070 | NIH | None | httpsreporternihgovquickSearchM01RR001070 |