Rosuvastatin Efficacy and Safety Evaluation in Hypercholesterolaemic Patients
Completed
- Conditions
- Hypercholesterolaemia
- Registration Number
- NCT00695539
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 810
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
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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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the percentage of patients on European LDL-C target at week 12 At 12 weeks of treatment 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
- Secondary Outcome Measures
Name Time Method Safety and tolerability Throughout the study Changes in HDL-C, TC and TG At week 12 & 24 of treatment
Trial Locations
- Locations (1)
Research Site
🇬🇷Thessaloniki, Greece