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RESEARCH: Rosuvastatin Efficacy and Safety Evaluation in Hypercholesterolaemic Patients

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00695539
Collaborator
(none)
810
Enrollment
6
Locations
12
Duration (Months)
135
Patients Per Site
11.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    810 participants
    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
    Study Start Date :
    Dec 1, 2007
    Actual Study Completion Date :
    Dec 1, 2008

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. To evaluate the percentage of patients on European LDL-C target at week 12 [At 12 weeks of treatment]

    Secondary Outcome Measures

    1. Changes in HDL-C, TC and TG [At week 12 & 24 of treatment]

    2. Safety and tolerability [Throughout the study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Research Site Alexandroupoli Greece
    2 Research Site Athens Greece
    3 Research Site Iraklio, Crete Greece
    4 Research Site Larissa Greece
    5 Research Site Rio, Patra Greece
    6 Research Site Thessaloniki Greece

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00695539
    Other Study ID Numbers:
    • NIS-CGR-CRE-2007/1
    First Posted:
    Jun 12, 2008
    Last Update Posted:
    Oct 5, 2009
    Last Verified:
    Oct 1, 2009
    Keywords provided by , ,
    Rosuvastatin
    hypercholesterolaemia
    Additional relevant MeSH terms:
    Hypercholesterolemia

    Study Results

    No Results Posted as of Oct 5, 2009