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Sponsors and Collaborators: |
Oregon Health and Science University Merck Oregon State University Indiana University |
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Information provided by: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00736463 |
Summary:
Background: There is a lot of interest in the function and role of HDL to prevent and mitigate atherosclerosis in patients who are at or near LDLc targets. Statins have variable effects on HDLc which are accentuated in patients with a low baseline HDLc. Higher doses of statins are being used more commonly in practice based on newer outcomes studies which find greater benefits of the higher doses compared to lower or standard doses. This study is testing FDA approved dosages of two commonly used statin medications.
Design: The study is designed to examine the effects of 80mg simvastatin and 80mg atorvastatin on HDLc concentrations. Serum will be saved for a hopeful collaborative effort with investigators at the U. of Washington who are able to do more advanced testing of HDL particle functionality. Based on the first 13 patients studied at Indiana University, the effects of these statins on HDLc concentrations vary greatly. It is unknown what impact these concentration changes have on the functionality of the particles however. A meta-analysis of 4 prospective trials published in JAMA in 2006 found that increasing HDLc with statins was independently associated with regression of atherosclerosis as measured by intravascular ultrasound.
Patients: Patients with low HDLc will be the primary population recruited. Exclusion criteria include interacting medications, pregnancy, baseline hepatic disease or other illnesses which would put patients at increased risk of statin side effects.
Condition | Intervention | Phase |
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HDL Cholesterol |
Drug: Simvastatin Drug: Atorvastatin 80 mg |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Effects of High Dose Simvastatin vs. Atorvastatin on Baseline Lipoprotein Profiles, Apo-A-1 and C Reactive Protein |
Estimated Enrollment: | 80 |
Study Start Date: | January 2005 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Aimvastatin 80 mg
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Drug: Simvastatin
One arm of randomized crossover
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2: Active Comparator
Atorvastatin 80 mg
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Drug: Atorvastatin 80 mg
Second arm of randomized crossover
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Craig D Williams, PharmD | 503-494-1598 | williacr@ohsu.edu |
Contact: Darlene Kitterman | 503-494-6263 | kitterma@ohsu.edu |
United States, Oregon | |
OHSU Hospital | Recruiting |
Portland, Oregon, United States, 97239 | |
Principal Investigator: Craig D Williams, PharmD |
Principal Investigator: | Craig D Williams | Oregon Health and Science University |
Responsible Party: | OHSU/OSU School of Pharmacy ( Craig D. Williams, Pharm.D. Clinical Associate Professor ) |
Study ID Numbers: | IRB00004506 |
Study First Received: | August 14, 2008 |
Last Updated: | August 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00736463 |
Health Authority: | United States: Food and Drug Administration |
HDL cholesterol statin inflammation |
atherosclerosis prevention patients with low baseline HDL cholesterol |
Atherosclerosis Simvastatin Atorvastatin Inflammation |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |