Evaluation of Combination Cholesterol Treatments in Patients With High Cholesterol.

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Inc.
Information provided by:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00249938
First received: November 3, 2005
Last updated: January 4, 2013
Last verified: January 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

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
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, see Learn About Clinical Studies.

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, Denver
Daiichi Sankyo Inc.
Investigators
Principal Investigator: Sunny Linnebur, Pharm.D. University of Colorado, Denver
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00249938     History of Changes
Other Study ID Numbers: 04-0823
Study First Received: November 3, 2005
Last Updated: January 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Antilipemic agents
hyperlipidemia

Additional relevant MeSH terms:
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014