Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: September 23, 2004
Last updated: November 17, 2016
Last verified: November 2016
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
Drug: MK0803, lovastatin
Behavioral: Self-Management System
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Consumer Use Study of OTC Lovastatin (CUSTOM): A 6-Month Consumer Behavior Study of the Lovastatin OTC Self-Management System

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

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
Study Start Date: December 2002
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Detailed Description:
The duration of treatment is 6 months.

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00092846

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00092846     History of Changes
Other Study ID Numbers: 0803-084  2004_061 
Study First Received: September 23, 2004
Last Updated: November 17, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
High Blood Cholesterol Levels

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
L 647318
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on January 17, 2017