Rosuvastatin Efficacy and Safety Evaluation in Hypercholesterolaemic Patients (RESEARCH)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00695539
First received: June 10, 2008
Last updated: October 2, 2009
Last verified: October 2009
  Purpose

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.


Condition
Hypercholesterolaemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Changes in HDL-C, TC and TG [ Time Frame: At week 12 & 24 of treatment ]
  • Safety and tolerability [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 810
Study Start Date: December 2007
Study Completion Date: December 2008
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary Care

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00695539

Locations
Greece
Research Site
Alexandroupoli, Greece
Research Site
Athens, Greece
Research Site
Iraklio, Crete, Greece
Research Site
Larissa, Greece
Research Site
Rio, Patra, Greece
Research Site
Thessaloniki, Greece
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: Panagiotis Pontikis, MD, Medical & Regulatory Affairs Director, AstraZeneca Greece, AstraZeneca S.A., Greece
ClinicalTrials.gov Identifier: NCT00695539     History of Changes
Other Study ID Numbers: NIS-CGR-CRE-2007/1
Study First Received: June 10, 2008
Last Updated: October 2, 2009
Health Authority: Greece: National Organization of Medicines

Keywords provided by AstraZeneca:
Rosuvastatin
hypercholesterolaemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014