Hypercholesterolaemia
Conditions
Keywords
Rosuvastatin, hypercholesterolaemia
Brief summary
This is a single-arm, phase IV, open-label, prospective, non interventional study to evaluate the efficacy, tolerability and safety of rosuvastatin administered for 24 weeks in approximately 900 Greek subjects with hypercholesterolemia under normal clinical practice.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with hypercholesterolaemia who are already in treatment with rosuvastatin according to the approved SPC for no longer than 1 month prior to study entry * Patients that are able to read, understand and sign the Patient Information & Consent Form * Patients that are willing to comply with all study requirements
Exclusion criteria
* Patients that are likely not to comply with all study requirements * Patients that currently participate or have participated in a 3 months period prior to study entry in another clinical trial * Female of child bearing potential that do not use a reliable method of contraception. Pregnancy or lactation. * Patients that meet any of the contraindications described in the approved SPC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The assessment of rosuvastatin efficacy in the reduction of low-density lipoprotein cholesterol (LDL-C) in subjects with hypercholesterolemia at week 12 of treatment compared with baseline | At 12 weeks of treatment |
| To evaluate the percentage of patients on European LDL-C target at week 12 | At 12 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Changes in HDL-C, TC and TG | At week 12 & 24 of treatment |
| Safety and tolerability | Throughout the study |
Countries
Greece
Outcome results
None listed