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

Sponsor

Organon and Co (Industry)

Overall Status

Completed

CT.gov ID

NCT00723723

Collaborator

Merck Sharp & Dohme LLC (Industry)

555

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease Hypercholesterolemia Hyperlipidemia	Drug: Statin

Study Design

Study Type:

Observational

Actual Enrollment :

555 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Compliance With LDL-Lowering Therapy For Secondary Prevention of Coronary Heart Disease in Real Life Practice

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Patients with coronary heart disease Patients being treated with a statin for secondary prevention of coronary heart disease	Drug: Statin Statin

Arm

Intervention/Treatment

Patients with coronary heart disease

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

Drug: Statin

Statin

Outcome Measures

Primary Outcome Measures

percentage of patients reaching target LDL levels [6-8 weeks after first visit and 28-32 weeks after first visit]

Secondary Outcome Measures

measure patient compliance to treatment as assessed by counting returned tablets [6-8 weeks after first visit and 28-32 weeks after first visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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