NCT01023503

Brief 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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
withdrawn

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

October 31, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
1.2 years until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 24, 2013

Status Verified

July 1, 2013

Enrollment Period

1.1 years

First QC Date

October 31, 2009

Last Update Submit

July 23, 2013

Conditions

Dyslipidemia

Keywords

StatinsDyslipidemiaSpainRosuvastatinNaiveSwitchingNew statins prescriptions in Spain (naive patients and switching)

Outcome Measures

Primary Outcomes (2)

  • Current and previous hypolipemic treatment, dose and pattern

    Retrospectively (information for the previous 6-months). Information collected once.

  • Statin treatment start date, origin of the prescription, reasons for changes in prescription

    Retrospectively (information for the previous 6-months). Information collected once.

Secondary Outcomes (3)

  • Socio-demographic characteristics

    retrospectively

  • Total Cholesterol, HDL, LDL, Triglycerides, ALAT, Glucose, Creatine Kinase plasma levels

    retrospectively

  • Concomitant Treatments and Cardiovascular History

    retrospectively

Study Arms (1)

1

Adults, with a new statin prescription or a change in their stain treatment

Eligibility Criteria

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

To be recruited by Primary Care Physicians

You may qualify if:

  • Patients receiving a new statin prescription (naïve patients)
  • Patients having a change in their statin prescription (dose, switching, addition to another hypolipemic drug)

You may not qualify if:

  • Patients without enough information in the medical records to complete the fields required in the eCRF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Barcelona, Spain

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases
0

Study Design

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

Study Record Dates

First Submitted

October 31, 2009

First Posted

December 2, 2009

Study Start

March 1, 2011

Primary Completion

April 1, 2012

Study Completion

July 1, 2012

Last Updated

July 24, 2013

Record last verified: 2013-07

Locations

ES(1)