Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079638
Status:
COMPLETED
Last Update Posted:
2006-11-01
First Post:
2004-03-10
Brief Title:
Comparative Efficacy Evaluation of Lipids When Treated With Niaspan Statin or Other Lipid-Modifying Therapies-COMPELL
Sponsor:
Kos Pharmaceuticals
Organization:
Kos Pharmaceuticals
Study Overview
Official Title:
Comparative Efficacy Evaluation of Lipid Levels When Treated With Niaspan and Statin or Other Lipid-Modifying Therapies
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 study is to evaluate the effectiveness of first-line treatment using Niaspan an extended release version of niacin and statins versus other drugs that lower lipid levels in subjects with elevated fat levels in their blood dyslipidemia Statins are a class of medication that is often prescribed to patients who need to lower their cholesterol levels
Detailed Description:
Name of Drugs Niaspan niacin extended-release tablets Lipitor atorvastatin Zocor simvastatin Zetia ezetimibe and Crestor rosuvastatin
Study Treatment Four open-label parallel treatment groups for 12 weeks of observation
Niaspan and atorvastatin combination treatment titrated to 2000 mg and 40 mg respectively
combination treatment of simvastatin titrated to 40 mg and ezetimibe maintained at 10 mg
rosuvastatin monotherapy treatment titrated to 40 mg and
Niaspan and rosuvastatin combination treatment titrated to 1000 mg and 20 mg respectively
Objective To evaluate the relative efficacy of first-line therapy using the combination of Niaspan and atorvastatin versus the combination of simvastatin and ezetimibe versus rosuvastatin monotherapy versus the combination of Niaspan and rosuvastatin in patients with dyslipidemia
Population
Male or female patients 21 years of age or older
Patients who are eligible for treatment based upon National Cholesterol Education Program Adult Treatment Panel III NCEP-ATP III recommendations at the end of the Qualification period
All patients must have mean triglycerides TG 300 mgdL
Design A Phase IV 12-week randomized multi-center open-label four-arm parallel-group study evaluating the efficacy of Niaspan and statin therapy versus other lipid-modifying therapies preceded by a four-week washout of any previous lipid-lowering therapy
Study Treatment Four open-label parallel treatment groups for 12 weeks of observation
Niaspan and atorvastatin combination treatment titrated to 2000 mg and 40 mg respectively
combination treatment of simvastatin titrated to 40 mg and ezetimibe maintained at 10 mg
rosuvastatin monotherapy treatment titrated to 40 mg and
Niaspan and rosuvastatin combination treatment titrated to 1000 mg and 20 mg respectively
Objective To evaluate the relative efficacy of first-line therapy using the combination of Niaspan and atorvastatin versus the combination of simvastatin and ezetimibe versus rosuvastatin monotherapy versus the combination of Niaspan and rosuvastatin in patients with dyslipidemia
Population
Male or female patients 21 years of age or older
Patients who are eligible for treatment based upon National Cholesterol Education Program Adult Treatment Panel III NCEP-ATP III recommendations at the end of the Qualification period
All patients must have mean triglycerides TG 300 mgdL
Design A Phase IV 12-week randomized multi-center open-label four-arm parallel-group study evaluating the efficacy of Niaspan and statin therapy versus other lipid-modifying therapies preceded by a four-week washout of any previous lipid-lowering therapy
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 |
|---|---|---|---|
| COMPELL | None | None | None |