Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00203476
Status:
COMPLETED
Last Update Posted:
2014-08-12
First Post:
2005-09-12
Brief Title:
A Prospective Open Label Comparison of Ezetimibe Niacin and Colestipol as Adjunct Therapy in Lipid Reduction
Sponsor:
Tuscaloosa Research Education Advancement Corporation
Organization:
Tuscaloosa Research Education Advancement Corporation
Study Overview
Official Title:
A Prospective Open Label Comparison of Ezetimibe Niacin and Colestipol as Adjunct Therapy in Lipid Reduction
Status:
COMPLETED
Status Verified Date:
2014-08
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:
To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA Reductase inhibitor statin therapy with adjunctive therapy with ezetimibe colestipol or niacin The patients cardiovascular risks are assessed to determine if National Cholesterol Education Programs Adult Treatment Panel III NCEP ATP III guidelines for low density lipoprotein LDL reduction were achieved between the three groups Secondary measures examine the safety issues with liver function test LFT monitoring and rhabdomyolysis High-density lipoproteins HDL elevations are monitored between the three groups to determine efficacy as a secondary outcome
Detailed Description:
Patients with hyperlipidemia who sign consent and who are currently at maximum tolerated dose of a statin and are not meeting NCEP ATPIII treatment goals for LDL cholesterol are enrolled in 12-week open label prospective trial Patients are randomized into one of three groups to receive ezetimibe niacin or colestipol in addition to current statin therapy Patients are titrated as tolerated to therapeutic doses of study medications ezetimibe 10mgday niacin 1500mgday and colestipol 20gmday At baseline informed consent a laboratory admission profile Chem20 weight height blood pressure concomitant medications cholesterol medication history and grapefruit juice consumption data are gathered At weeks 6 and 12 patients have their cholesterol panels and liver function tests assessed Patients are also interviewed regarding side effects including rhabdomyolysis tolerance changes in concomitant medications and grapefruit juice consumption along with weight and blood pressure measurements
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 |
|---|---|---|---|
| TREAC Cholesterol Study | None | None | None |