Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Tuscaloosa Research & Education Advancement Corporation American Society of Health-System Pharmacists Research and Education Foundation |
---|---|
Information provided by: | Tuscaloosa Research & Education Advancement Corporation |
ClinicalTrials.gov Identifier: | NCT00203476 |
To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or niacin. The patient’s cardiovascular risks are assessed to determine if National Cholesterol Education Program’s Adult Treatment Panel III (NCEP ATP III) guidelines for low density lipoprotein (LDL) reduction were achieved between the three groups. Secondary measures examine the safety issues with liver function test (LFT) monitoring and rhabdomyolysis. High-density lipoproteins (HDL) elevations are monitored between the three groups to determine efficacy as a secondary outcome.
Condition | Intervention | Phase |
---|---|---|
Hyperlipidemia Hypercholesterolemia |
Drug: ezetimibe Drug: niacin Drug: colestipol |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction |
Estimated Enrollment: | 90 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | May 2008 |
: Patients with hyperlipidemia who sign consent and who are currently at maximum tolerated dose of a statin and are not meeting NCEP ATPIII treatment goals for LDL cholesterol are enrolled in 12-week open label, prospective trial. Patients are randomized into one of three groups to receive ezetimibe, niacin, or colestipol in addition to current statin therapy. Patients are titrated as tolerated to therapeutic doses of study medications (ezetimibe 10mg/day, niacin 1500mg/day, and colestipol 20gm/day). At baseline, informed consent; a laboratory admission profile (Chem20); weight; height; blood pressure; concomitant medications; cholesterol medication history; and grapefruit juice consumption data are gathered. At weeks 6 and 12, patients have their cholesterol panels and liver function tests assessed. Patients are also interviewed regarding side effects (including rhabdomyolysis), tolerance, changes in concomitant medications, and grapefruit juice consumption, along with weight and blood pressure measurements.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Tuscaloosa Research & Education Advancement Corporation | Recruiting |
Tuscaloosa, Alabama, United States, 35404 | |
Contact: Raela B Williford, PharmD 205-554-2000 ext 2733 Raela.Williford@va.gov | |
Principal Investigator: Raela B Williford, PharmD |
Principal Investigator: | Raela B Williford, PharmD | Tuscaloosa VA Medical Center |
Study ID Numbers: | TREAC Cholesterol Study, TREAC Cholesterol Study |
Study First Received: | September 12, 2005 |
Last Updated: | March 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00203476 |
Health Authority: | United States: Food and Drug Administration |
ezetimibe niacin colestipol |
hyperlipidemia adjunct therapy zetia |
Nicotinic Acids Metabolic Diseases Hyperlipidemias Colestipol Ezetimibe |
Metabolic disorder Niacin Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Vasodilator Agents Vitamin B Complex Molecular Mechanisms of Pharmacological Action Antilipemic Agents Growth Substances Physiological Effects of Drugs |
Cardiovascular Agents Anticholesteremic Agents Pharmacologic Actions Therapeutic Uses Vitamins Micronutrients |