A 6-Month Consumer Behavior Study of a Self-Management System (0803-084)(COMPLETED)
This study has been completed.
Information provided by:
First received: September 23, 2004
Last updated: May 24, 2013
Last verified: May 2013
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.
Drug: MK0803, lovastatin
Behavioral: Self-Management System
|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:
U.S. FDA Resources
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.
|Primary Completion Date:||September 2003 (Final data collection date for primary outcome measure)|
The duration of treatment is 6 months.
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