Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00365742
Status:
COMPLETED
Last Update Posted:
2006-08-17
First Post:
2006-08-16
Brief Title:
Statin Therapy Vs Therapeutic Lifestyle Changes and Supplements
Sponsor:
Chestnut Hill Health System
Organization:
Chestnut Hill Health System
Study Overview
Official Title:
Simvastatin Vs Therapeutic Lifestyle Changes and Supplements A Primary Prevention Randomized Trial
Status:
COMPLETED
Status Verified Date:
2006-08
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:
Randomized trial in a primary prevention population
all participants have high LDL cholesterol
Group one will take simvastatin 40 mgday Group Two will make therapeutic lifestyle changesand take supplements consisting of red yeast rice and fish oil
all participants have high LDL cholesterol
Group one will take simvastatin 40 mgday Group Two will make therapeutic lifestyle changesand take supplements consisting of red yeast rice and fish oil
Detailed Description:
This is a randomized primary prevention trial to compare the LDL lowering effects of an alternative regimen to statinssimvastatin This alternative regimen is over the counter and available at health food stores The alternative regimen consists of lifestyle changes including a Mediterranean Dietexercise program and stress reduction with red yeast rice 1200 mg twice per day and fish oil 6 gramsday The second group run at the same time will take Zocorsimvastatin 40 mg per day with standard counseling
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