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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092846
• Other study ID #: 0803-084
• Secondary ID: 2004_061
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2004
• Last updated: September 28, 2017
• Start date: December 4, 2002

Study information

• Verified date: September 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The duration of treatment is 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. primary completion date: September 1, 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• MK0803, lovastatin

Behavioral:
• Self-Management System

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who make appropriate decision for self-management.
Secondary	Percentage of patients who make appropriate decision to discontinue therapy or consult with a physician; the incidence of adverse experiences.