NCT00695539
Completed
Not Applicable
A Multi-centre, Open Label, Non-randomised, Non Interventional, 24 Weeks Study for the Efficacy and Safety of Rosuvastatin Following Its Administration in Real Life Clinical Practice in Greek Hypercholesterolaemic Patients
ConditionsHypercholesterolaemia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypercholesterolaemia
- Sponsor
- AstraZeneca
- Enrollment
- 810
- Locations
- 1
- Primary Endpoint
- To evaluate the percentage of patients on European LDL-C target at week 12
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
To evaluate the percentage of patients on European LDL-C target at week 12
Time Frame: 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
Time Frame: At 12 weeks of treatment
Secondary Outcomes
- Safety and tolerability(Throughout the study)
- Changes in HDL-C, TC and TG(At week 12 & 24 of treatment)
Study Sites (1)
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