Evaluation of Combination Cholesterol Treatments in Patients With High Cholesterol.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00249938
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : March 28, 2017
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Dyslipidemia Drug: Minute Maid Heart Wise orange juice Drug: Welchol Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Evaluation of Plant Sterol and Placebo on Low-density Lipoprotein Concentrations in Hyperlipidemic Patients Treated With Combination Statin and Colesevelam Therapy.
Study Start Date : March 2005
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. LDL cholesterol

Secondary Outcome Measures :
  1. Triglycerides, HDL cholesterol, total cholesterol, C-reactive protein, Apolipoprotein B

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00249938

United States, Colorado
University of Colorado at Denver and Health Sciences Center
Denver, Colorado, United States, 80262
Sponsors and Collaborators
University of Colorado, Denver
Daiichi Sankyo, Inc.
Principal Investigator: Sunny Linnebur, Pharm.D. University of Colorado, Denver

Responsible Party: University of Colorado, Denver Identifier: NCT00249938     History of Changes
Other Study ID Numbers: 04-0823
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

Keywords provided by University of Colorado, Denver:
Antilipemic agents

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases