A 6-Month Consumer Behavior Study of a Self-Management System - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: MK0803, lovastatin Behavioral: Self-Management System	Phase III

Genetics Home Reference related topics:

hypercholesterolemia

MedlinePlus related topics:

Cholesterol

ChemIDplus related topics:

Cholest-5-en-3-ol (3beta)- Lovastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Consumer Use Study of OTC Lovastatin (CUSTOM): A 6-Month Consumer Behavior Study of the Lovastatin OTC Self-Management System

Further study details as provided by Merck:

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.

Estimated Enrollment:

1000

Detailed Description:

The duration of treatment is 6 months.

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications:

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.

Study ID Numbers:	2004_061
First Received:	September 23, 2004
Last Updated:	July 5, 2006
ClinicalTrials.gov Identifier:	NCT00092846
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

High Blood Cholesterol Levels

Study placed in the following topic categories:

Metabolic Diseases

Hyperlipidemias

Metabolic disorder

Hypercholesterolemia

Lovastatin

Dyslipidemias

Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antilipemic Agents

Enzyme Inhibitors

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 09, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092846