Dyslipidaemia Clinical Trial
— STEPOfficial title:
Statin Therapy Results in the Real World Practice in the Czech Republic
| Verified date | August 2011 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Czech Republic: State Institute for Drug Control |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 3253 |
| Est. completion date | June 2010 |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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: |
Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Czech Republic | Research Site | Benesov | |
| Czech Republic | Research Site | Beroun | |
| Czech Republic | Research Site | Blansko | |
| Czech Republic | Research Site | Bohumin | |
| Czech Republic | Research Site | Boskovice | |
| Czech Republic | Research Site | Brandys nad Labem | |
| Czech Republic | Research Site | Brno | |
| Czech Republic | Research Site | Ceska Lipa | |
| Czech Republic | Research Site | ceske Budejovice | |
| Czech Republic | Research Site | cesky Krumlov | |
| Czech Republic | Research Site | Cheb | |
| Czech Republic | Research Site | Chomutov | |
| Czech Republic | Research Site | Chrudim | |
| Czech Republic | Research Site | Decin | |
| Czech Republic | Research Site | Domazlice | |
| Czech Republic | Research Site | Dvur Kralove nad Labem | |
| Czech Republic | Research Site | Frydek-Mistek | |
| Czech Republic | Research Site | Havirov | |
| Czech Republic | Research Site | Havlickuv Brod | |
| Czech Republic | Research Site | Hradec Kralove | |
| Czech Republic | Research Site | Hustopece | |
| Czech Republic | Research Site | Ivancice | |
| Czech Republic | Research Site | Jablonec nad Nisou | |
| Czech Republic | Research Site | Jesenik | |
| Czech Republic | Research Site | Jicin | |
| Czech Republic | Research Site | Jihlava | |
| Czech Republic | Research Site | Jindrichuv Hradec | |
| Czech Republic | Research Site | Karlovy Vary | |
| Czech Republic | Research Site | Karvina | |
| Czech Republic | Research Site | Kladno | |
| Czech Republic | Research Site | Kolin | |
| Czech Republic | Research Site | Krnov | |
| Czech Republic | Research Site | Kurim | |
| Czech Republic | Research Site | Kutna Hora | |
| Czech Republic | Research Site | Kyjov | |
| Czech Republic | Research Site | Liberec | |
| Czech Republic | Research Site | Litomerice | |
| Czech Republic | Research Site | Louny | |
| Czech Republic | Research Site | Melnik | |
| Czech Republic | Research Site | Mestec Kralove | |
| Czech Republic | Research Site | Mikulov | |
| Czech Republic | Research Site | Milevsko | |
| Czech Republic | Research Site | Mlada Boleslav | |
| Czech Republic | Research Site | Moravska Trebova | |
| Czech Republic | Research Site | Moravske Budejovice | |
| Czech Republic | Research Site | Moravsky Krumlov | |
| Czech Republic | Research Site | Most | |
| Czech Republic | Research Site | Nachod | |
| Czech Republic | Research Site | Novy Bydzov | |
| Czech Republic | Research Site | Olomouc | |
| Czech Republic | Research Site | Opava | |
| Czech Republic | Research Site | Orlova | |
| Czech Republic | Research Site | Ostrava | |
| Czech Republic | Research Site | Ostrov nad Ohri | |
| Czech Republic | Research Site | Pardubice | |
| Czech Republic | Research Site | Pelhrimov | |
| Czech Republic | Research Site | Pisek | |
| Czech Republic | Research Site | Plzen | |
| Czech Republic | Research Site | Police nad Metuji | |
| Czech Republic | Research Site | Policka | |
| Czech Republic | Research Site | Prachatice | |
| Czech Republic | Research Site | Praha 1 | |
| Czech Republic | Research Site | Praha 10 | |
| Czech Republic | Research Site | Praha 2 | |
| Czech Republic | Research Site | Praha 3 | |
| Czech Republic | Research Site | Praha 4 | |
| Czech Republic | Research Site | Praha 5 | |
| Czech Republic | Research Site | Praha 6 | |
| Czech Republic | Research Site | Praha 8 | |
| Czech Republic | Research Site | Praha 9 | |
| Czech Republic | Research Site | Prerov | |
| Czech Republic | Research Site | Prestice | |
| Czech Republic | Research Site | Pribram | |
| Czech Republic | Research Site | Prostejov | |
| Czech Republic | Research Site | Rakovnik | |
| Czech Republic | Research Site | Roudnice nad Labem | |
| Czech Republic | Research Site | Roznov pod Radhostem | |
| Czech Republic | Research Site | Rychnov nad Kneznou | |
| Czech Republic | Research Site | Semily | |
| Czech Republic | Research Site | Slany | |
| Czech Republic | Research Site | Smirice | |
| Czech Republic | Research Site | Sternberk | |
| Czech Republic | Research Site | Strakonice | |
| Czech Republic | Research Site | Susice | |
| Czech Republic | Research Site | Svitavy | |
| Czech Republic | Research Site | Tabor | |
| Czech Republic | Research Site | Teplice | |
| Czech Republic | Research Site | Tisnov | |
| Czech Republic | Research Site | Trebic | |
| Czech Republic | Research Site | Trinec | |
| Czech Republic | Research Site | Trutnov | |
| Czech Republic | Research Site | Turnov | |
| Czech Republic | Research Site | Uherske Hradiste | |
| Czech Republic | Research Site | Usti nad Labem | |
| Czech Republic | Research Site | Valasske Klobouky | |
| Czech Republic | Research Site | Veseli nad Moravou | |
| Czech Republic | Research Site | Vitkovice | |
| Czech Republic | Research Site | Vsetin | |
| Czech Republic | Research Site | Vyskov | |
| Czech Republic | Research Site | Vysoke Myto | |
| Czech Republic | Research Site | Zamberk | |
| Czech Republic | Research Site | Zlin | |
| Czech Republic | Research Site | Znojmo |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Czech Republic,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | LDL-C | one year | No | |
| Secondary | Total cholesterol | one year | No | |
| Secondary | HDL-C | one year | No | |
| Secondary | triglycerides | one year | No |
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