- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00249938
Evaluation of Combination Cholesterol Treatments in Patients With High Cholesterol.
March 24, 2017 updated by: University of Colorado, Denver
Evaluation of Plant Sterol and Placebo on Low-density Lipoprotein Concentrations in Hyperlipidemic Patients Treated With Combination Statin and Colesevelam Therapy.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80262
- University of Colorado at Denver and Health Sciences Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
LDL cholesterol
|
Secondary Outcome Measures
Outcome Measure |
---|
Triglycerides, HDL cholesterol, total cholesterol, C-reactive protein, Apolipoprotein B
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Study Completion (Actual)
August 1, 2006
Study Registration Dates
First Submitted
November 3, 2005
First Submitted That Met QC Criteria
November 4, 2005
First Posted (Estimate)
November 7, 2005
Study Record Updates
Last Update Posted (Actual)
March 28, 2017
Last Update Submitted That Met QC Criteria
March 24, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-0823
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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