A 6-Month Consumer Behavior Study of a Self-Management System
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...
Brief Summary
Official Title: “A Consumer Use Study of OTC Lovastatin (CUSTOM): A 6-Month Consumer Behavior Study of the Lovastatin OTC Self-Management System”
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.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Detailed Clinical Trial Description
The duration of treatment is 6 months.
Intervention(s) in this Clinical Trial
- Drug: MK0803, lovastatin
- Behavioral: Self-Management System
Outcome Measures for this Clinical Trial
Primary Measures
- Percentage of patients who make appropriate decision for self-management.
Secondary Measures
- Percentage of patients who make appropriate decision to discontinue therapy or consult with a physician; the incidence of adverse experiences.
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 45 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: Merck Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00092846
Study ID Number: 2004_061
ClinicalTrials.gov Identifier: NCT00092846
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00092846
