Pattern of Statins Use in Catalonia

February 20, 2012 updated by: AstraZeneca
To describe the new statins prescription pattern in Catalonia (getting their first prescription for any statin, or receiving a change in their statin treatment including switching, changing in doses or adding ezetimibe/fibrates) since September 2009.

Study Overview

Status

Completed

Conditions

Detailed Description

Pattern of statins use in Catalonia.

Study Type

Observational

Enrollment (Actual)

180723

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hypercolesterolemic patients in treatment with statins.

Description

Inclusion Criteria

  • Patient with a new prescription of statin Patients receiving one or more changes of the statins treatment

Exclusion Criteria

  • Patient with not full information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of detailed clinical treatment in terms of duration of treatment, doses, drug switches and add-on therapy, in patients with hypercholesterolemia and on treatment with statins from the index date.
Time Frame: From 1st September 2009 to 30th August 2010
From 1st September 2009 to 30th August 2010
Type of prescriber
Time Frame: From 1st September 2009 to 30th August 2010
Number of patient, whom the drug was prescribed by the specified type of prescriber (specialist, general practitioner, etc.)
From 1st September 2009 to 30th August 2010
Date of change from previous statin to new.
Time Frame: From 1st September 2009 to 30th August 2010
From 1st September 2009 to 30th August 2010

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of demographic data including: Sex, Age, Height (cm), Weight (kg), Smoking habits (packs-years), Alcohol consume habits (units/week), active worker or retired, Pregnancy.
Time Frame: From 1st September 2009 to 30th August 2010
From 1st September 2009 to 30th August 2010
Total cholesterol
Time Frame: From 1st September 2009 to 30th August 2010

Total Cholesterol data was collected till the last laboratory values before the date of change from previous statin to new statin.

That values will be collected for all the patients fulfilling criteria.
From 1st September 2009 to 30th August 2010
Low Density Lipoprotein (LDL) cholesterol concentration
Time Frame: From 1st September 2009 to 30th August 2010
LDL cholesterol data was collected till the last laboratory values before the date of change from previous statin to new statin.
From 1st September 2009 to 30th August 2010
High Density Lipoproteins (HDL) cholesterol concentration
Time Frame: From 1st September 2009 to 30th August 2010
HDL data was collected till the last laboratory values before the date of change from previous statin to new statin.
From 1st September 2009 to 30th August 2010
Triglicerides (TG) concentration
Time Frame: From 1st September 2009 to 30th August 2010
TG data was collected till the last laboratory values before the date of change from previous statin to new statin.
From 1st September 2009 to 30th August 2010
Aspartate Aminotransferase (ASAT) concentration
Time Frame: From 1st September 2009 to 30th August 2010
ASAT data was collected till the last laboratory values before the date of change from previous statin to new statin.
From 1st September 2009 to 30th August 2010
Serum Glucose concentration
Time Frame: From 1st September 2009 to 30th August 2010
Serum Glucose data was collected till the last laboratory values before the date of change from previous statin to new statin.
From 1st September 2009 to 30th August 2010
Serum Creatin Kinase (CK) concentration
Time Frame: From 1st September 2009 to 30th August 2010
CK data was collected till the last laboratory values before the date of change from previous statin to new statin.
From 1st September 2009 to 30th August 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

November 18, 2011

First Submitted That Met QC Criteria

November 22, 2011

First Posted (Estimate)

November 23, 2011

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 20, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CES-CRE-2011/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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