Rosuvastatin Efficacy and Safety Evaluation in Hypercholesterolaemic Patients

Hypercholesterolaemia Clinical Trial

— RESEARCH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695539
• Other study ID #: NIS-CGR-CRE-2007/1
• Status: Completed
• Phase: N/A
• First received: June 10, 2008
• Last updated: October 2, 2009
• Start date: December 2007
• Est. completion date: December 2008

Study information

• Verified date: October 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 810
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypercholesterolaemia
• Hypercholesterolemia

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	To evaluate the percentage of patients on European LDL-C target at week 12		At 12 weeks of treatment
Secondary	Changes in HDL-C, TC and TG		At week 12 & 24 of treatment
Secondary	Safety and tolerability		Throughout the study	Yes