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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-04

Brief Summary

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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

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The duration of treatment is 6 months.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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MK0803, lovastatin

Intervention Type DRUG

Self-Management System

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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.

Reference Type BACKGROUND

PMID: 15541238 (View on PubMed)

Study Documents

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Document Type: CSR Synopsis

View Document

Other Identifiers

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2004_061

Identifier Type: -

Identifier Source: secondary_id

0803-084