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OpenTrials
Completed

NCT Number: NCT00249938

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.

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Key information

Conditions

Hyperlipidemia Dyslipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Colorado at Denver and Health Sciences Center

Denver, Colorado, 80262, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minute Maid Heart Wise orange juice

Drug

Welchol

Drug

Primary outcomes

  1. LDL cholesterol

Secondary outcomes

  1. Triglycerides, HDL cholesterol, total cholesterol, C-reactive protein, Apolipoprotein B

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Daiichi Sankyo

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2006
First posted
Nov 7, 2005
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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