Rosuvastatin Efficacy and Safety Evaluation in Hypercholesterolaemic Patients (RESEARCH)

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

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 Overview

• Status: Completed
• Conditions: Hypercholesterolaemia

• Study Type: Observational
• Enrollment (Actual): 810

Contacts and Locations

Study Locations

• Greece
  • Alexandroupoli, Greece
    • Research Site
  • Athens, Greece
    • Research Site
  • Iraklio, Crete, Greece
    • Research Site
  • Larissa, Greece
    • Research Site
  • Rio, Patra, Greece
    • Research Site
  • Thessaloniki, Greece
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary Care

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Changes in HDL-C, TC and TG	At week 12 & 24 of treatment
Safety and tolerability	Throughout the study

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion: December 7, 2022
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: June 10, 2008
• First Submitted That Met QC Criteria: June 11, 2008
• First Posted (Estimate): June 12, 2008

Study Record Updates

• Last Update Posted (Estimate): October 5, 2009
• Last Update Submitted That Met QC Criteria: October 2, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: Rosuvastatin; hypercholesterolaemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: NIS-CGR-CRE-2007/1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No