Statin Therapy Results in the Real World Practice in the Czech Republic (STEP)

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. Identifier: NCT01055977
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : August 30, 2011
Information provided by (Responsible Party):

Brief Summary:

Statins are the first choice treatment of dyslipidemia, a major contributor to cardiovascular diseases. Statins also have enough evidence to demonstrate decrease of morbidity and mortality from cardiovascular diseases. Even though statin therapy is effective treatment of dyslipidaemia not all patients reach the goal levels.

The aim of the study is to estimate proportion of patients who achieved the therapeutic goal (LDL-C. total cholesterol, HDL-C and triglycerides levels) after at least one year of a statin therapy.

Condition or disease

Study Type : Observational
Estimated Enrollment : 3253 participants
Time Perspective: Retrospective
Official Title: Statin Therapy Results in the Real World Practice in the Czech Republic
Study Start Date : February 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. LDL-C [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Total cholesterol [ Time Frame: one year ]
  2. HDL-C [ Time Frame: one year ]
  3. triglycerides [ Time Frame: one year ]

Information from the National Library of Medicine

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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
specialist care clinics

Inclusion Criteria:

  • Documented statin therapy for at least 12 months
  • Available two LDL-C values: one at the beginning of statin therapy or at the time when patient comes to a specialist; and the other one at least after 12 months of treatment. The latter value should not be older than 6 months.

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01055977

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Sponsors and Collaborators
Study Director: Ales Kminek AstraZeneca
Principal Investigator: Jaromir Hradec General faculty hospital Prague
Principal Investigator: Jan Bultas Faculty hospital Kralovske Vinohrady Prague

Responsible Party: AstraZeneca Identifier: NCT01055977     History of Changes
Other Study ID Numbers: NIS-CCZ-CRE-2009/1
First Posted: January 26, 2010    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011

Keywords provided by AstraZeneca:
statin therapy
treatment goal

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents