Rosuvastatin Efficacy and Safety Evaluation in Hypercholesterolaemic Patients

AstraZeneca810 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

810

Conditions

Hypercholesterolaemia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (6)

Research Site

Alexandroupoli, Greece

Research Site

Athens, Greece

Research Site

Iraklio, Crete, Greece

Research Site

Larissa, Greece

Research Site

Outcomes

Primary Outcomes

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

Time frame: At 12 weeks of treatment

To evaluate the percentage of patients on European LDL-C target at week 12

Time frame: At 12 weeks of treatment

Secondary Outcomes

Changes in HDL-C, TC and TG

Time frame: At week 12 & 24 of treatment

Safety and tolerability

Time frame: Throughout the study

Data from ClinicalTrials.gov

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