- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01055977
Statin Therapy Results in the Real World Practice in the Czech Republic (STEP)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Benesov, Czech Republic
- Research Site
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Beroun, Czech Republic
- Research Site
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Blansko, Czech Republic
- Research Site
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Bohumin, Czech Republic
- Research Site
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Boskovice, Czech Republic
- Research Site
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Brandys nad Labem, Czech Republic
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Brno, Czech Republic
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Ceska Lipa, Czech Republic
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Cheb, Czech Republic
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Chomutov, Czech Republic
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Chrudim, Czech Republic
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Decin, Czech Republic
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Domazlice, Czech Republic
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Dvur Kralove nad Labem, Czech Republic
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Frydek-Mistek, Czech Republic
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Havirov, Czech Republic
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Havlickuv Brod, Czech Republic
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Hradec Kralove, Czech Republic
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Hustopece, Czech Republic
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Ivancice, Czech Republic
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Jablonec nad Nisou, Czech Republic
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Jesenik, Czech Republic
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Jicin, Czech Republic
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Jihlava, Czech Republic
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Jindrichuv Hradec, Czech Republic
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Karlovy Vary, Czech Republic
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Karvina, Czech Republic
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Kladno, Czech Republic
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Kolin, Czech Republic
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Krnov, Czech Republic
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Kurim, Czech Republic
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Kutna Hora, Czech Republic
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Kyjov, Czech Republic
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Liberec, Czech Republic
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Litomerice, Czech Republic
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Louny, Czech Republic
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Melnik, Czech Republic
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Mestec Kralove, Czech Republic
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Mikulov, Czech Republic
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Milevsko, Czech Republic
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Mlada Boleslav, Czech Republic
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Moravska Trebova, Czech Republic
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Moravske Budejovice, Czech Republic
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Moravsky Krumlov, Czech Republic
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Most, Czech Republic
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Nachod, Czech Republic
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Novy Bydzov, Czech Republic
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Olomouc, Czech Republic
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Opava, Czech Republic
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Orlova, Czech Republic
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Ostrava, Czech Republic
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Ostrov nad Ohri, Czech Republic
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Pardubice, Czech Republic
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Pelhrimov, Czech Republic
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Pisek, Czech Republic
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Plzen, Czech Republic
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Police nad Metuji, Czech Republic
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Policka, Czech Republic
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Prachatice, Czech Republic
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Praha 1, Czech Republic
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Praha 10, Czech Republic
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Praha 2, Czech Republic
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Praha 3, Czech Republic
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Praha 4, Czech Republic
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Praha 5, Czech Republic
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Praha 6, Czech Republic
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Praha 8, Czech Republic
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Praha 9, Czech Republic
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Prerov, Czech Republic
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Prestice, Czech Republic
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Pribram, Czech Republic
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Prostejov, Czech Republic
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Rakovnik, Czech Republic
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Roudnice nad Labem, Czech Republic
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Roznov pod Radhostem, Czech Republic
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Rychnov nad Kneznou, Czech Republic
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Semily, Czech Republic
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Slany, Czech Republic
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Smirice, Czech Republic
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Sternberk, Czech Republic
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Strakonice, Czech Republic
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Susice, Czech Republic
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Svitavy, Czech Republic
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Tabor, Czech Republic
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Teplice, Czech Republic
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Tisnov, Czech Republic
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Trebic, Czech Republic
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Trinec, Czech Republic
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Trutnov, Czech Republic
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Turnov, Czech Republic
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Uherske Hradiste, Czech Republic
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Usti nad Labem, Czech Republic
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Valasske Klobouky, Czech Republic
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Veseli nad Moravou, Czech Republic
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Vitkovice, Czech Republic
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Vsetin, Czech Republic
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Vyskov, Czech Republic
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Vysoke Myto, Czech Republic
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Zamberk, Czech Republic
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Zlin, Czech Republic
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Znojmo, Czech Republic
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ceske Budejovice, Czech Republic
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cesky Krumlov, Czech Republic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
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Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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LDL-C
Time Frame: one year
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one year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Total cholesterol
Time Frame: one year
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one year
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HDL-C
Time Frame: one year
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one year
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triglycerides
Time Frame: one year
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one year
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ales Kminek, AstraZeneca
- Principal Investigator: Jaromir Hradec, General faculty hospital Prague
- Principal Investigator: Jan Bultas, Faculty hospital Kralovske Vinohrady Prague
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-CCZ-CRE-2009/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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