Compliance With LDL-Lowering Therapy (Study P05467)(COMPL... | NCT00723723

Studies
Compliance With LDL-Lowering Therapy (Study P05467)(COMPLETED)

NCT00723723

Sponsor

Organon and Co

Status

Completed

Last Update Posted

Feb 16, 2022Actual

Enrollment

555Actual

Phase

Not provided

Conditions

Coronary Heart Disease
Hypercholesterolemia
Hyperlipidemia

Interventions

Statin

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

Status Module

Record Verification Date

Feb 2022

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

Jan 2008

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Jul 25, 2008

First Submission Date that Met QC Criteria

Jul 25, 2008

First Posted Date

Jul 29, 2008Estimated

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

Feb 7, 2022

Last Update Posted Date

Feb 16, 2022Actual

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This observational study is being conducted in patients receiving statin treatment as secondary prevention of coronary heart disease under the current standard of care in compliance with European guidelines. The purpose of the study is to evaluate the percentage of these patients that reach target LDL levels. Additionally this study will measure the patient's compliance to treatment as assessed by counting the returned tablets. Both assessments will be made at visits conducted 6-8 weeks after the first visit and 28-32 weeks after the first visit.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

555Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with coronary heart disease		Patients being treated with a statin for secondary prevention of coronary heart disease	Drug: Statin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Statin	Drug	Statin	Patients with coronary heart disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percentage of patients reaching target LDL levels		6-8 weeks after first visit and 28-32 weeks after first visit

Secondary Outcomes

Measure	Description	Time Frame
measure patient compliance to treatment as assessed by counting returned tablets		6-8 weeks after first visit and 28-32 weeks after first visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

willingness to participate in the study
18 years of age or more
clinically established cardiovascular disease to be considered as patients in secondary prevention
prior therapy with any statin without achieving goal (2.5 mmol/L of LDL cholesterol) at last lipid check performed

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients being treated with a statin for secondary prevention of coronary heart disease

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease
D006937	Hypercholesterolemia
D006949	Hyperlipidemias

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019161	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Ancestor Terms

ID	Term
D000924	Anticholesteremic Agents
D000960	Hypolipidemic Agents
D000963	Antimetabolites
D045504	Molecular Mechanisms of Pharmacological Action

Browse Leaves

Not provided

Browse Branches

Not provided