Evaluation of Combination Cholesterol Treatments in Patients With High Cholesterol.

NCT ID: NCT00249938

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2006-08-31

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.

Conditions

Hyperlipidemia; Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Minute Maid Heart Wise orange juice

Intervention Type: DRUG

Welchol

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sunny Linnebur, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado at Denver and Health Sciences Center

Denver, Colorado, United States

Countries

United States

Other Identifiers

04-0823

Identifier Type: -

Identifier Source: org_study_id