Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249938
Status:
COMPLETED
Last Update Posted:
2017-03-28
First Post:
2005-11-03
Brief Title:
Evaluation of Combination Cholesterol Treatments in Patients With High Cholesterol
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Evaluation of Plant Sterol and Placebo on Low-density Lipoprotein Concentrations in Hyperlipidemic Patients Treated With Combination Statin and Colesevelam Therapy
Status:
COMPLETED
Status Verified Date:
2017-03
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 see if combination therapy with a statin medication and two additional agents that work differently than statin medications can further lower the so-called bad cholesterol One therapy is a prescription drug approved by the Food and Drug Administration to treat high cholesterol Welchol The other therapy is Minute Maid Heart Wise orange juice This study juice is available in supermarkets and contains plant sterols that have been shown to lower cholesterol
Detailed Description:
Coronary heart disease CHD is the primary cause of morbidity and mortality in the United States Lowering LDL cholesterol in both patients with and without CHD reduces coronary events and death Statin medications are the primary mechanism of lowering LDL cholesterol but some patients do not reach their goal LDL with maximum tolerated statin doses and must utilize combination therapy to further lower cholesterol Additionally some patients prefer to utilize natural mechanisms to lower cholesterol This prospective double-blinded randomized study will compare plant sterol natural cholesterol treatment with placebo in patients treated with combination statin and colesevelam 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