Rosuvastatin Efficacy and Safety Evaluation in 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.

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Key information

Conditions

Hypercholesterolaemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Alexandroupoli, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: RESEARCH

Important dates

Study start: 2007
Study completion: 2008
First posted: Jun 12, 2008
Registry last updated: Oct 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed