Evaluation of Combination Cholesterol Treatments in Patients With High Cholesterol.

Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00249938
• Other study ID #: 04-0823
• Status: Completed
• Phase: Phase 4
• First received: November 3, 2005
• Last updated: March 24, 2017
• Start date: March 2005
• Est. completion date: August 2006

Study information

• Verified date: March 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• Minute Maid Heart Wise orange juice

• Welchol

Locations

Country	Name	City	State
United States	University of Colorado at Denver and Health Sciences Center	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Daiichi Sankyo Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL cholesterol
Secondary	Triglycerides, HDL cholesterol, total cholesterol, C-reactive protein, Apolipoprotein B