Evaluation of Combination Cholesterol Treatments in Patients With High Cholesterol.

Evaluation of Plant Sterol and Placebo on Low-density Lipoprotein Concentrations in Hyperlipidemic Patients Treated With Combination Statin and Colesevelam Therapy.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00249938

Enrollment

Registered

2005-11-07

Start date

2005-03-31

Completion date

2006-08-31

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Hyperlipidemia

Keywords

Antilipemic agents, hyperlipidemia

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.

Interventions

DRUGMinute Maid Heart Wise orange juice

DRUGWelchol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
LDL cholesterol	—

Secondary

Measure	Time frame
Triglycerides, HDL cholesterol, total cholesterol, C-reactive protein, Apolipoprotein B	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026