Evaluation of Combination Cholesterol Treatments in Patients With High Cholesterol. - Full Text View

Sponsors and Collaborators:	University of Colorado at Denver and Health Sciences Center Daiichi Sankyo Inc.
Information provided by:	University of Colorado at Denver and Health Sciences Center
ClinicalTrials.gov Identifier:	NCT00249938

Purpose

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.

Condition	Intervention	Phase
Hyperlipidemia Dyslipidemia	Drug: Minute Maid Heart Wise orange juice Drug: Welchol	Phase IV

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Cholest-5-en-3-ol (3beta)- Colesevelam GT31-104

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Plant Sterol and Placebo on Low-Density Lipoprotein Concentrations in Hyperlipidemic Patients Treated With Combination Statin and Colesevelam Therapy.

Further study details as provided by University of Colorado at Denver and Health Sciences Center:

Primary Outcome Measures:

LDL cholesterol

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	March 2005
Estimated Study Completion Date:	August 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249938

Locations

United States, Colorado
University of Colorado at Denver and Health Sciences Center
Denver, Colorado, United States, 80262

Sponsors and Collaborators

University of Colorado at Denver and Health Sciences Center

Daiichi Sankyo Inc.

Investigators

Principal Investigator:

Sunny Linnebur, Pharm.D.

University of Colorado at Denver and Health Sciences Center

More Information

Study ID Numbers:	OJ01
Study First Received:	November 3, 2005
Last Updated:	January 17, 2007
ClinicalTrials.gov Identifier:	NCT00249938
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Colorado at Denver and Health Sciences Center:

Antilipemic agents
hyperlipidemia

Study placed in the following topic categories:

Colesevelam
Metabolic Diseases
Hyperlipidemias

Metabolic disorder
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009