Evaluation of Combination Cholesterol Treatments in Patients With High Cholesterol.
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.
Drug: Minute Maid Heart Wise orange juice
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Evaluation of Plant Sterol and Placebo on Low-density Lipoprotein Concentrations in Hyperlipidemic Patients Treated With Combination Statin and Colesevelam Therapy.|
- LDL cholesterol
- Triglycerides, HDL cholesterol, total cholesterol, C-reactive protein, Apolipoprotein B
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||August 2006|
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.
|United States, Colorado|
|University of Colorado at Denver and Health Sciences Center|
|Denver, Colorado, United States, 80262|
|Principal Investigator:||Sunny Linnebur, Pharm.D.||University of Colorado, Denver|