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...
Date First Received: September 23, 2004
Last Updated: July 5, 2006
Verified by: Merck, September 2005
Clinical Trial Phase: Phase 3 | Start Date:
Overall Status: Completed
Estimated Enrollment: 1000
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”
Condition Keyword(s):
Intervention(s):
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: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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 Sponsor Information
Lead Sponsor: 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 November 18, 2008
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
Clinical Trials Authorship and Review
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