NCT01477944

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180,723

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

Same day

First QC Date

November 18, 2011

Last Update Submit

February 20, 2012

Conditions

Keywords

Statins pattern of useHypercholesterolemic patientsStatins

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Date of change from previous statin to new.

    From 1st September 2009 to 30th August 2010

Secondary Outcomes (8)

  • 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

  • Total cholesterol

    From 1st September 2009 to 30th August 2010

  • Low Density Lipoprotein (LDL) cholesterol concentration

    From 1st September 2009 to 30th August 2010

  • High Density Lipoproteins (HDL) cholesterol concentration

    From 1st September 2009 to 30th August 2010

  • Triglicerides (TG) concentration

    From 1st September 2009 to 30th August 2010

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hypercolesterolemic patients in treatment with statins.

You may qualify if:

  • Patient with a new prescription of statin Patients receiving one or more changes of the statins treatment

You may not qualify if:

  • Patient with not full information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2011

First Posted

November 23, 2011

Study Start

February 1, 2012

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 22, 2012

Record last verified: 2012-02