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

This study has been completed.
Information provided by:
Merck Sharp & Dohme Corp. Identifier:
First received: July 25, 2008
Last updated: September 12, 2014
Last verified: September 2014

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
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:

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
Other Name: Statin


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


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 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
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on July 30, 2015