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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092846

Enrollment

1000

Registered

2004-09-28

Start date

2002-12-04

Completion date

Unknown

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

High Blood Cholesterol Levels

Brief summary

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.

Detailed description

The duration of treatment is 6 months.

Interventions

DRUGMK0803, lovastatin

BEHAVIORALSelf-Management System

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Percentage of patients who make appropriate decision for self-management.	—

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026