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Effectiveness of Two Approved Drugs in Lowering High Cholesterol (0733-224)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0733, simvastatin
Comparator: simvastatin
Sponsored by
Organon and Co
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring High cholesterol

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Elevated cholesterol level Exclusion Criteria: Liver disease Known allergies to study drugs

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Fasting triglyceride levels at 12 weeks.

    Secondary Outcome Measures

    Total Cholesterol, LDL-C, HDL-C, VLDL-C, VLDL-TG, Apo A-I, and Apo B, CRP, PAI-1, fibrinogen, fasting plasma glucose, and fasting insulin

    Full Information

    First Posted
    September 21, 2004
    Last Updated
    February 3, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00092157
    Brief Title
    Effectiveness of Two Approved Drugs in Lowering High Cholesterol (0733-224)
    Official Title
    A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Tolerability and Efficacy of the Co-Administration of Simvastatin 20 mg/Day and Fenofibrate 160 mg/Day Compared to Simvastatin 20 mg/Day Alone for 12 Weeks of Treatment in Patients With Combined Hyperlipidemia-Simvastatin and Fenofibrate Efficacy Trial (SAFARI)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2002 (Actual)
    Primary Completion Date
    March 3, 2003 (Actual)
    Study Completion Date
    March 4, 2003 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and effectiveness of two approved drugs in lowering high cholesterol when taken together, compared to taking only one of the drugs.
    Detailed Description
    The duration of treatment is 12 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia
    Keywords
    High cholesterol

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    571 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0733, simvastatin
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: simvastatin
    Primary Outcome Measure Information:
    Title
    Fasting triglyceride levels at 12 weeks.
    Secondary Outcome Measure Information:
    Title
    Total Cholesterol, LDL-C, HDL-C, VLDL-C, VLDL-TG, Apo A-I, and Apo B, CRP, PAI-1, fibrinogen, fasting plasma glucose, and fasting insulin

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Elevated cholesterol level Exclusion Criteria: Liver disease Known allergies to study drugs
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15695129
    Citation
    Grundy SM, Vega GL, Yuan Z, Battisti WP, Brady WE, Palmisano J. Effectiveness and tolerability of simvastatin plus fenofibrate for combined hyperlipidemia (the SAFARI trial). Am J Cardiol. 2005 Feb 15;95(4):462-8. doi: 10.1016/j.amjcard.2004.10.012. Erratum In: Am J Cardiol. 2006 Aug 1;98(3):427-8.
    Results Reference
    background
    PubMed Identifier
    19660610
    Citation
    Grundy SM, Vega GL, Tomassini JE, Tershakovec AM. Correlation of non-high-density lipoprotein cholesterol and low-density lipoprotein cholesterol with apolipoprotein B during simvastatin + fenofibrate therapy in patients with combined hyperlipidemia (a subanalysis of the SAFARI trial). Am J Cardiol. 2009 Aug 15;104(4):548-53. doi: 10.1016/j.amjcard.2009.04.018.
    Results Reference
    background
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Effectiveness of Two Approved Drugs in Lowering High Cholesterol (0733-224)

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