Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129402
Status:
COMPLETED
Last Update Posted:
2022-02-08
First Post:
2005-08-09
Brief Title:
Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With HeFH Study P02579
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
Efficacy Safety and Tolerability of Ezetimibe in Coadministration With Simvastatin in the Therapy of Adolescents With Heterozygous Familial Hypercholesterolemia
Status:
COMPLETED
Status Verified Date:
2022-02
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 is a randomized double-blind controlled parallel-group multicenter Phase-3 study to evaluate the efficacy and safety of ezetimibe with simvastatin taken alone in subjects ages 10-17 years with Heterozygous Familial Hypercholesterolemia
Detailed Description:
This study consisted of 3 distinct periods In Period 1 subjects received daily treatment for 6 weeks as part of either the ezetimibe with simvastatin group or part of the simvastatin monotherapy group Subjects in the ezetimibe with simvastatin group received one of three treatments coadministration of ezetimibe 10 mgday plus simvastatin 10 mgday 20 mgday or 40 mgday Subjects in the simvastatin monotherapy group received one of three treatments ezetimibe placebo plus simvastatin 10 mgday 20 mgday or 40 mgday The primary and key secondary efficacy analysis were based on the evaluations performed during Period 1 and were presented as data for subjects pooled from either the ezetimibe with simvastatin treatment groups compared with data for subjects pooled from the simvastatin monotherapy treatment groups
In Period 2 subjects received ezetimibe 10 mgday plus simvastatin 40 mgday or ezetimibe placebo plus simvastatin 40 mgday for 27 additional weeks maintaining the same treatment assignment coadministration vs monotherapy as in Period 1
In Period 3 all subjects received ezetimibe 10 mgday plus open-label simvastatin daily for 20 weeks
In Period 2 subjects received ezetimibe 10 mgday plus simvastatin 40 mgday or ezetimibe placebo plus simvastatin 40 mgday for 27 additional weeks maintaining the same treatment assignment coadministration vs monotherapy as in Period 1
In Period 3 all subjects received ezetimibe 10 mgday plus open-label simvastatin daily for 20 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DOC ID 2526810 | None | None | None |
| EUDRACT NUMBER2004-002627-40 | None | None | None |
| SCH 58235 | None | None | None |