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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00723723
Recruitment Status : Completed
First Posted : July 29, 2008
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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
Coronary Heart Disease Hypercholesterolemia Hyperlipidemia Drug: Statin

Study Design
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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 : January 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

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Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. percentage of patients reaching target LDL levels [ Time Frame: 6-8 weeks after first visit and 28-32 weeks after first visit ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00723723    
Other Study ID Numbers: P05467
First Posted: July 29, 2008    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Hypercholesterolemia
Hyperlipidemias
Cardiovascular Diseases
 Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases