A 6-Month Consumer Behavior Study of a Self-Management Sy... | NCT00092846

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

NCT00092846

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Oct 2, 2017Actual

Enrollment

1,000Estimated

Phase

Phase 3

Conditions

Hypercholesterolemia

Interventions

MK0803, lovastatin
Self-Management System

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2004_061

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 4, 2002Actual

Primary Completion Date

Sep 1, 2003Actual

Completion Date

Not provided

First Submitted Date

Sep 23, 2004

First Submission Date that Met QC Criteria

Sep 27, 2004

First Posted Date

Sep 28, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2017

Last Update Posted Date

Oct 2, 2017Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients who make appropriate decision for self-management.

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15541238	Background	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. doi: 10.1016/j.amjcard.2004.08.007.

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

ID	Term
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Name	Type	Description	Arm Group Labels	Other Names
MK0803, lovastatin	Drug
Self-Management System	Behavioral