search
Back to results

A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet (LOCUST)

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
simvastatin 20 mg/ezetimibe
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperlipidemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Moderately obese with hyperlipidemia

Exclusion Criteria:

  • Recent unstable heart or lung condition
  • Current use of other lipid modifying drugs
  • Hepatic disease
  • Pregnancy or lactation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    2

    Arm Description

    Low carb diet plus simvastatin 20 mg/ezetimibe 10 mg

    Outcomes

    Primary Outcome Measures

    LDL cholesterol

    Secondary Outcome Measures

    Other lipid measures
    Safety and tolerability

    Full Information

    First Posted
    November 29, 2007
    Last Updated
    November 30, 2007
    Sponsor
    Merck Sharp & Dohme LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00566267
    Brief Title
    A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet
    Acronym
    LOCUST
    Official Title
    A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    People who follow a low-carbohydrate diet typically experience a decrease in triglycerides and increase in HDL-C level, but fail to lower their LDL cholesterol (LDL-C). Such patients may require lipid-lowering therapy. Statins may not be the most effective strategy for patients on this diet, since they typically consume a greater amount of saturated fat and cholesterol. Absorbed cholesterol may contribute more to their circulating plasma LDL-C. We hypothesize that patients following a low carbohydrate diet would experience a significantly greater decrease in LDL-C by taking ezetimibe 10 mg, a drug that blocks cholesterol uptake in the intestine, in addition to simvastatin 20 mg, when compared to taking simvastatin 20 mg alone.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperlipidemia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    58 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Low carb diet plus simvastatin 20 mg/ezetimibe 10 mg
    Intervention Type
    Drug
    Intervention Name(s)
    simvastatin 20 mg/ezetimibe
    Other Intervention Name(s)
    Low carb diet plus simvastatin 20 mg
    Intervention Description
    see protocol
    Primary Outcome Measure Information:
    Title
    LDL cholesterol
    Time Frame
    8 weeks of treatment
    Secondary Outcome Measure Information:
    Title
    Other lipid measures
    Time Frame
    8 weeks of treatment
    Title
    Safety and tolerability
    Time Frame
    8 weeks treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Moderately obese with hyperlipidemia Exclusion Criteria: Recent unstable heart or lung condition Current use of other lipid modifying drugs Hepatic disease Pregnancy or lactation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frederick F Samaha, M.D.
    Organizational Affiliation
    Philadelphia VAMC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20435205
    Citation
    Chirinos JA, Williams MM, Bregman DB, Ashfaq H, Khayyam U, Iqbal N. Efficacy of cholesterol uptake inhibition added to statin therapy among subjects following a low-carbohydrate diet: a randomized controlled trial. Am Heart J. 2010 May;159(5):918.e1-6. doi: 10.1016/j.ahj.2010.02.010.
    Results Reference
    derived

    Learn more about this trial

    A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet

    We'll reach out to this number within 24 hrs