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Pattern of Statins Use in Catalonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01477944
First received: November 18, 2011
Last updated: February 20, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition
Hypercholesteremia

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Pattern of Statins Use in Catalonia

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Statins
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Type of prescriber [ Time Frame: From 1st September 2009 to 30th August 2010 ] [ Designated as safety issue: No ]
    Number of patient, whom the drug was prescribed by the specified type of prescriber (specialist, general practitioner, etc.)

  • Date of change from previous statin to new. [ Time Frame: From 1st September 2009 to 30th August 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Total cholesterol [ Time Frame: From 1st September 2009 to 30th August 2010 ] [ Designated as safety issue: No ]

    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.


  • Low Density Lipoprotein (LDL) cholesterol concentration [ Time Frame: From 1st September 2009 to 30th August 2010 ] [ Designated as safety issue: No ]
    LDL cholesterol data was collected till the last laboratory values before the date of change from previous statin to new statin.

  • High Density Lipoproteins (HDL) cholesterol concentration [ Time Frame: From 1st September 2009 to 30th August 2010 ] [ Designated as safety issue: No ]
    HDL data was collected till the last laboratory values before the date of change from previous statin to new statin.

  • Triglicerides (TG) concentration [ Time Frame: From 1st September 2009 to 30th August 2010 ] [ Designated as safety issue: No ]
    TG data was collected till the last laboratory values before the date of change from previous statin to new statin.

  • Aspartate Aminotransferase (ASAT) concentration [ Time Frame: From 1st September 2009 to 30th August 2010 ] [ Designated as safety issue: No ]
    ASAT data was collected till the last laboratory values before the date of change from previous statin to new statin.

  • Serum Glucose concentration [ Time Frame: From 1st September 2009 to 30th August 2010 ] [ Designated as safety issue: No ]
    Serum Glucose data was collected till the last laboratory values before the date of change from previous statin to new statin.

  • Serum Creatin Kinase (CK) concentration [ Time Frame: From 1st September 2009 to 30th August 2010 ] [ Designated as safety issue: No ]
    CK data was collected till the last laboratory values before the date of change from previous statin to new statin.


Enrollment: 180723
Study Start Date: February 2012
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Pattern of statins use in Catalonia.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hypercolesterolemic patients in treatment with statins.

Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01477944     History of Changes
Other Study ID Numbers: NIS-CES-CRE-2011/1
Study First Received: November 18, 2011
Last Updated: February 20, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by AstraZeneca:
Statins pattern of use
Hypercholesterolemic patients
Statins

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013