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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00723723
First received: July 25, 2008
Last updated: April 10, 2013
Last verified: April 2013
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:

U.S. FDA Resources

Further study details as provided by Merck:

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
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: April 10, 2013
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Hypercholesterolemia
Hyperlipidemias
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Dyslipidemias
 Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013