Evaluation of Combination Cholesterol Treatments in Patients With High Cholesterol.
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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. |
- LDL cholesterol
- Triglycerides, HDL cholesterol, total cholesterol, C-reactive protein, Apolipoprotein B
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | August 2006 |
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 |
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| United States, Colorado | |
| University of Colorado at Denver and Health Sciences Center | |
| Denver, Colorado, United States, 80262 | |
| 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:
|
Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Colesevelam Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 13, 2013