Evaluation of Combination Cholesterol Treatments in Patients With High Cholesterol.
Evaluation of Plant Sterol and Placebo on Low-density Lipoprotein Concentrations in Hyperlipidemic Patients Treated With Combination Statin and Colesevelam Therapy.
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 3, 2005
CompletedFirst Posted
Study publicly available on registry
November 7, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedMarch 28, 2017
March 1, 2017
November 3, 2005
March 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LDL cholesterol
Secondary Outcomes (1)
Triglycerides, HDL cholesterol, total cholesterol, C-reactive protein, Apolipoprotein B
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of high cholesterol being treated with a statin
- LDL cholesterol greater than 100
- Ability to swallow large tablets
You may not qualify if:
- Diabetes
- Use of other medications to treat high cholesterol
- History of liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- Daiichi Sankyocollaborator
Study Sites (1)
University of Colorado at Denver and Health Sciences Center
Denver, Colorado, 80262, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sunny Linnebur, Pharm.D.
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2005
First Posted
November 7, 2005
Study Start
March 1, 2005
Study Completion
August 1, 2006
Last Updated
March 28, 2017
Record last verified: 2017-03