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

This study has been completed.

Sponsor:

Information provided by:

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00723723

First received: July 25, 2008

Last updated: September 12, 2014

Last verified: September 2014

History of Changes

Purpose

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.

Condition	Intervention
Coronary Heart Disease Hypercholesterolemia Hyperlipidemia	Drug: Statin


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Compliance With LDL-Lowering Therapy For Secondary Prevention of Coronary Heart Disease in Real Life Practice

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases Statins

Genetic and Rare Diseases Information Center resources: Sphingolipidosis

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

percentage of patients reaching target LDL levels [ Time Frame: 6-8 weeks after first visit and 28-32 weeks after first visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

measure patient compliance to treatment as assessed by counting returned tablets [ Time Frame: 6-8 weeks after first visit and 28-32 weeks after first visit ] [ Designated as safety issue: No ]


Enrollment:	555
Study Start Date:	January 2008
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients with coronary heart disease Patients being treated with a statin for secondary prevention of coronary heart disease	Drug: Statin Statin Other Name: Statin

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

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

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.

No Contacts or Locations Provided

More Information

No publications provided


Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00723723 History of Changes
Other Study ID Numbers:	P05467
Study First Received:	July 25, 2008
Last Updated:	September 12, 2014
Health Authority:	Slovenia: Agency for Medicinal Products - Ministry of Health

Additional relevant MeSH terms:


Coronary Artery Disease Coronary Disease Heart Diseases Hypercholesterolemia Myocardial Ischemia Arterial Occlusive Diseases Arteriosclerosis	Cardiovascular Diseases Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Vascular Diseases

ClinicalTrials.gov processed this record on March 01, 2015

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