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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00092846
First received: September 23, 2004
Last updated: May 24, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Hypercholesterolemia
 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:

MedlinePlus related topics: Cholesterol
Drug Information available for: Lovastatin
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.

Estimated Enrollment: 1000
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Detailed Description:

The duration of treatment is 6 months.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092846

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Publications:

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00092846     History of Changes
Other Study ID Numbers: 2004_061
Study First Received: September 23, 2004
Last Updated: May 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
High Blood Cholesterol Levels

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lovastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013