Observational Study To Evaluate Statins Patterns Of Use In Spain

This study has suspended participant recruitment.

(Changes affecting Post Authorization Study Regulatory effective from Dec09, impacted the requirements for Spanish studies at National and Regional level.)

Sponsor:

Collaborator:

Fundació Institut Català de Farmacologia

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01023503

First received: October 31, 2009

Last updated: March 8, 2011

Last verified: March 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	October 31, 2009
Last Updated Date	March 8, 2011
Start Date ^ICMJE	March 2011
Estimated Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 1, 2009)	Current and previous hypolipemic treatment, dose and pattern [ Time Frame: Retrospectively (information for the previous 6-months). Information collected once. ] [ Designated as safety issue: No ] Statin treatment start date, origin of the prescription, reasons for changes in prescription [ Time Frame: Retrospectively (information for the previous 6-months). Information collected once. ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01023503 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 1, 2009)	Socio-demographic characteristics [ Time Frame: retrospectively ] [ Designated as safety issue: No ] Total Cholesterol, HDL, LDL, Triglycerides, ALAT, Glucose, Creatine Kinase plasma levels [ Time Frame: retrospectively ] [ Designated as safety issue: No ] Concomitant Treatments and Cardiovascular History [ Time Frame: retrospectively ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Observational Study To Evaluate Statins Patterns Of Use In Spain
Official Title ^ICMJE	Statins Use Patterns in Spain
Brief Summary	The present project is aimed at describing the statins prescription pattern in Spanish patients. It will also look into how adequate these prescriptions are accordingly to the recommendations given in Treatment Guidelines and in the Summary Product Information.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	To be recruited by Primary Care Physicians
Condition ^ICMJE	Dyslipidemia
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	1 Adults, with a new statin prescription or a change in their stain treatment
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Suspended
Estimated Enrollment ^ICMJE	900
Estimated Completion Date	July 2012
Estimated Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients receiving a new statin prescription (naïve patients) Patients having a change in their statin prescription (dose, switching, addition to another hypolipemic drug) Exclusion Criteria: Patients without enough information in the medical records to complete the fields required in the eCRF
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT01023503
Other Study ID Numbers ^ICMJE	NIS-CES-CRE-2009/1
Has Data Monitoring Committee	No
Responsible Party	MC MD, AstraZeneca
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Fundació Institut Català de Farmacologia
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	March 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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