Observational Study To Evaluate Statins Patterns Of Use In Spain

Dyslipidemia Clinical Trial

Official title:

Statins Use Patterns in Spain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01023503
• Other study ID #: NIS-CES-CRE-2009/1
• Status: Withdrawn
• Phase: N/A
• First received: October 31, 2009
• Last updated: July 23, 2013
• Start date: March 2011
• Est. completion date: July 2012

Study information

• Verified date: July 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Locations

Country	Name	City	State
Spain	Research Site	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Fundació Institut Català de Farmacologia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Current and previous hypolipemic treatment, dose and pattern		Retrospectively (information for the previous 6-months). Information collected once.	No
Primary	Statin treatment start date, origin of the prescription, reasons for changes in prescription		Retrospectively (information for the previous 6-months). Information collected once.	No
Secondary	Socio-demographic characteristics		retrospectively	No
Secondary	Total Cholesterol, HDL, LDL, Triglycerides, ALAT, Glucose, Creatine Kinase plasma levels		retrospectively	No
Secondary	Concomitant Treatments and Cardiovascular History		retrospectively	No