Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-26 @ 1:42 PM
Study NCT ID:
NCT02089867
Status:
COMPLETED
Last Update Posted:
2014-03-19
First Post:
2014-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plant Sterols Effect on Previous Statin Therapy
Sponsor:
Jose Rocha Faria Neto
Organization:
Study Overview
Official Title:
A Randomized Open Label Trial to Assess the Effect of Plant Sterols Associated With Ezetimibe in LDL-cholesterol Levels in Coronary Patients Previously on Statin Therapy
Status:
COMPLETED
Status Verified Date:
2014-03
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:
The purpose of this study is to determine the effect of plant sterols associated with ezetimibe in LDL-cholesterol levels in coronary patients previously on statin therapy
Detailed Description:
Background: Consumption of food products enriched with plant sterols and treatment with ezetimibe both reduce cholesterol absorption in the intestine by different mechanisms and effectively reduce LDL cholesterol (LDL-c) plasma levels. Although, the associated usage of ezetimibe to plants sterols in coronary patients not reaching recommended lipid levels despite the use of statins has not yet been demonstrated. Objectives: Evaluate if ezetimibe 10mg associated to plant sterols spread enriched with 2g of plant sterols in coronary patients not reaching recommended lipid levels despite the use of statins is able to reduce cholesterol levels after 6 week treatment. Methods: Prospective, open-label study with both male and female patients with stable coronary disease and LDL \> 70mg/dL. Patients will be randomized for the following 6 week treatment: control group (CT) no additional statin therapy, ezetimibe group (EZ) 10 mg/day ezetimibe, plant sterol group (PS) spread enriched with 2g of plant sterols or ezetimibe+plant sterols group (EZ+PS) 10mg/day EZ + 2g PS. Anthropometric evaluations and laboratory exams (blood glucose test, total cholesterol, LDL-c, HDL-c, triglycerides, and C-Reactive Protein) will be performed in all groups at baseline and after the sixth week intervention.
Study Oversight
Has Oversight DMC:
False
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?: