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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092846
First received: September 23, 2004
Last updated: May 24, 2013
Last verified: May 2013
  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:


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
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
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 ClinicalTrials.gov identifier: NCT00092846

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  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 Sharp & Dohme Corp.:
High Blood Cholesterol Levels

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

ClinicalTrials.gov processed this record on August 26, 2014