Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080275
Status:
COMPLETED
Last Update Posted:
2006-11-01
First Post:
2004-03-25
Brief Title:
Evaluation of the Safety Efficacy of a Combination of Niacin ER Simvastatin in Patients With Dyslipidemia OCEANS
Sponsor:
Kos Pharmaceuticals
Organization:
Kos Pharmaceuticals
Study Overview
Official Title:
An Open-Label Evaluation of the Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients With Dyslipidemia OCEANS
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this 24 week study is to compare the effectiveness and safety of different doses of Niacin ERSimvastatin NS in subjects with elevated fat levels in their blood dyslipidemia
At least 600 subjects with a similar medical condition will take part in this study
At least 600 subjects with a similar medical condition will take part in this study
Detailed Description:
Objectives
To evaluate the safety and efficacy of the combination product niacin ER and simvastatin NS in patients with primary type II dyslipidemia and to descriptively compare flushing rates between two Titration Schedules for NS
To evaluate the safety and efficacy of the combination product niacin ER and simvastatin NS in patients with primary type II dyslipidemia and to descriptively compare flushing rates between two Titration Schedules for NS
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 |
|---|---|---|---|
| OCEANS | None | None | None |