Pattern of Statins Use in Catalonia

Hypercholesteremia Clinical Trial

Official title:

Pattern of Statins Use in Catalonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01477944
• Other study ID #: NIS-CES-CRE-2011/1
• Status: Completed
• Phase: N/A
• First received: November 18, 2011
• Last updated: February 20, 2012
• Start date: February 2012
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial Summary

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.

Description:

Pattern of statins use in Catalonia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180723
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hypercholesteremia
• Hypercholesterolemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		From 1st September 2009 to 30th August 2010	No
Primary	Type of prescriber	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	No
Primary	Date of change from previous statin to new.		From 1st September 2009 to 30th August 2010	No
Secondary	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.		From 1st September 2009 to 30th August 2010	No
Secondary	Total cholesterol	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	No
Secondary	Low Density Lipoprotein (LDL) cholesterol concentration	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	No
Secondary	High Density Lipoproteins (HDL) cholesterol concentration	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	No
Secondary	Triglicerides (TG) concentration	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	No
Secondary	Aspartate Aminotransferase (ASAT) concentration	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	No
Secondary	Serum Glucose concentration	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	No
Secondary	Serum Creatin Kinase (CK) concentration	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	No