Evaluation of Combination Cholesterol Treatments in Patients With High Cholesterol.

Phase 4

Completed

• Conditions: Hyperlipidemia; Dyslipidemia

• Registration Number: NCT00249938
• Lead Sponsor: University of Colorado, Denver

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 Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-11-03
• Study First Submitted QC: 2005-11-04
• Study First Posted: 2005-11-07
• Study Completion: 2006-08
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Diagnosis of high cholesterol being treated with a statin
• LDL cholesterol greater than 100
• Ability to swallow large tablets

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Exclusion Criteria

• Diabetes
• Use of other medications to treat high cholesterol
• History of liver disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
LDL cholesterol

Secondary Outcome Measures

Name	Time	Method
Triglycerides, HDL cholesterol, total cholesterol, C-reactive protein, Apolipoprotein B

Trial Locations

Locations (1)

University of Colorado at Denver and Health Sciences Center; 🇺🇸 Denver, Colorado, United States