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Crossover of Higher Dose Statins in Patients With Low High-density Lipoproteins Cholesterol (HDLc)

NCT00736463 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-07-22

No results posted yet for this study

Summary

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.

Conditions

  • HDL Cholesterol

Interventions

DRUG

Simvastatin

One arm of randomized crossover

DRUG

Atorvastatin 80 mg

Second arm of randomized crossover

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Oregon State University

    collaborator OTHER

  • Indiana University

    collaborator OTHER

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Craig D Williams · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2012-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00736463 on ClinicalTrials.gov