We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pattern of Statins Use in Catalonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01477944
Recruitment Status : Completed
First Posted : November 23, 2011
Last Update Posted : February 22, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Hypercholesteremia

Detailed Description:
Pattern of statins use in Catalonia.

Study Design

Study Type : Observational
Actual Enrollment : 180723 participants
Time Perspective: Retrospective
Official Title: Pattern of Statins Use in Catalonia
Study Start Date : February 2012
Primary Completion Date : February 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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.)

  3. Date of change from previous statin to new. [ Time Frame: From 1st September 2009 to 30th August 2010 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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.


  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01477944     History of Changes
Other Study ID Numbers: NIS-CES-CRE-2011/1
First Posted: November 23, 2011    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012

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
Enzyme Inhibitors
Lipid Regulating Agents