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NCT00723723 Clinical Trial

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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00723723
Other study ID # P05467
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2008
Est. completion date June 2009

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 555
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Statin
Statin

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Organon and Co Merck Sharp & Dohme Corp.

Outcome
Type Measure Description Time frame Safety issue
Primary percentage of patients reaching target LDL levels 6-8 weeks after first visit and 28-32 weeks after first visit
Secondary measure patient compliance to treatment as assessed by counting returned tablets 6-8 weeks after first visit and 28-32 weeks after first visit
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