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A 6-Month Consumer Behavior Study of a Self-Management System (0803-084)(COMPLETED)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0803, lovastatin
Self-Management System
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypercholesterolemia focused on measuring High Blood Cholesterol Levels

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Must be able to read and understand English without assistance. For Males: Minimum age 45 years and Maximum age N/A (No limit). For Females: Minimum age 55 years and Maximum age N/A (No limit). Exclusion Criteria: Pregnant or nursing Drug allergy

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Percentage of patients who make appropriate decision for self-management.

    Secondary Outcome Measures

    Percentage of patients who make appropriate decision to discontinue therapy or consult with a physician; the incidence of adverse experiences.

    Full Information

    First Posted
    September 23, 2004
    Last Updated
    September 28, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00092846
    Brief Title
    A 6-Month Consumer Behavior Study of a Self-Management System (0803-084)(COMPLETED)
    Official Title
    A Consumer Use Study of OTC Lovastatin (CUSTOM): A 6-Month Consumer Behavior Study of the Lovastatin OTC Self-Management System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 4, 2002 (Actual)
    Primary Completion Date
    September 1, 2003 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the ability of patients with intermediate risk of heart disease to appropriately use a Self-Management System.
    Detailed Description
    The duration of treatment is 6 months.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    1000 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0803, lovastatin
    Intervention Type
    Behavioral
    Intervention Name(s)
    Self-Management System
    Primary Outcome Measure Information:
    Title
    Percentage of patients who make appropriate decision for self-management.
    Secondary Outcome Measure Information:
    Title
    Percentage of patients who make appropriate decision to discontinue therapy or consult with a physician; the incidence of adverse experiences.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Must be able to read and understand English without assistance. For Males: Minimum age 45 years and Maximum age N/A (No limit). For Females: Minimum age 55 years and Maximum age N/A (No limit). Exclusion Criteria: Pregnant or nursing Drug allergy
    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
    15541238
    Citation
    Melin JM, Struble WE, Tipping RW, Reynolds JM, Vassil TC, Levy SJ, Petrohoy TM, Midgette P, Hemwall EL, Levine JG, Irvin JD. A Consumer Use Study of Over-The-Counter lovastatin (CUSTOM). Am J Cardiol. 2004 Nov 15;94(10):1243-8. doi: 10.1016/j.amjcard.2004.08.007.
    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

    A 6-Month Consumer Behavior Study of a Self-Management System (0803-084)(COMPLETED)

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