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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01055977
First received: January 25, 2010
Last updated: August 29, 2011
Last verified: August 2011
History of Changes
  Purpose

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
Dyslipidaemia

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Statin Therapy Results in the Real World Practice in the Czech Republic

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Statins
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • LDL-C [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total cholesterol [ Time Frame: one year ] [ Designated as safety issue: No ]
  • HDL-C [ Time Frame: one year ] [ Designated as safety issue: No ]
  • triglycerides [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 3253
Study Start Date: February 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01055977     History of Changes
Other Study ID Numbers: NIS-CCZ-CRE-2009/1
Study First Received: January 25, 2010
Last Updated: August 29, 2011
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by AstraZeneca:
statin therapy
treatment goal
dyslipidaemia

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013