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Completed

NCT Number: NCT00092846

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

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

The duration of treatment is 6 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0803, lovastatin

Drug

Self-Management System

Behavioral

Primary outcomes

  1. Percentage of patients who make appropriate decision for self-management.

Secondary outcomes

  1. Percentage of patients who make appropriate decision to discontinue therapy or consult with a physician; the incidence of adverse experiences.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2003
First posted
Sep 28, 2004
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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