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

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

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
Dyslipidaemia

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

U.S. FDA Resources




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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
specialist care clinics
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01055977


  Show 103 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
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
ClinicalTrials.gov 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
dyslipidaemia

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