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

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ClinicalTrials.gov Identifier: NCT00092846
Recruitment Status : Completed
First Posted : September 28, 2004
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

September 23, 2004
September 28, 2004
October 2, 2017
December 4, 2002
September 1, 2003   (Final data collection date for primary outcome measure)
Percentage of patients who make appropriate decision for self-management.
Not Provided
Complete list of historical versions of study NCT00092846 on ClinicalTrials.gov Archive Site
Percentage of patients who make appropriate decision to discontinue therapy or consult with a physician; the incidence of adverse experiences.
Not Provided
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A 6-Month Consumer Behavior Study of a Self-Management System (0803-084)(COMPLETED)
A Consumer Use Study of OTC Lovastatin (CUSTOM): A 6-Month Consumer Behavior Study of the Lovastatin OTC Self-Management System
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.
The duration of treatment is 6 months.
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Hypercholesterolemia
  • Drug: MK0803, lovastatin
  • Behavioral: Self-Management System
Not Provided
Melin JM, Struble WE, Tipping RW, Reynolds JM, Vassil TC, Levy SJ, Petrohoy TM, Midgette P, Hemwall EL, Levine JG, Irvin JD. A Consumer Use Study of Over-The-Counter lovastatin (CUSTOM). Am J Cardiol. 2004 Nov 15;94(10):1243-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
Not Provided
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September 1, 2003   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
45 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00092846
0803-084
2004_061
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP