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Observational Study To Evaluate Statins Patterns Of Use In Spain

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ClinicalTrials.gov Identifier: NCT01023503
Recruitment Status : Withdrawn (Changes affecting Post Authorization Study Regulatory effective from Dec09, impacted the requirements for Spanish studies at National and Regional level.)
First Posted : December 2, 2009
Last Update Posted : July 24, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Dyslipidemia

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Time Perspective: Retrospective
Official Title: Statins Use Patterns in Spain
Study Start Date : March 2011
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
Adults, with a new statin prescription or a change in their stain treatment


Outcome Measures

Primary Outcome Measures :
  1. Current and previous hypolipemic treatment, dose and pattern [ Time Frame: Retrospectively (information for the previous 6-months). Information collected once. ]
  2. Statin treatment start date, origin of the prescription, reasons for changes in prescription [ Time Frame: Retrospectively (information for the previous 6-months). Information collected once. ]

Secondary Outcome Measures :
  1. Socio-demographic characteristics [ Time Frame: retrospectively ]
  2. Total Cholesterol, HDL, LDL, Triglycerides, ALAT, Glucose, Creatine Kinase plasma levels [ Time Frame: retrospectively ]
  3. Concomitant Treatments and Cardiovascular History [ Time Frame: retrospectively ]

Eligibility Criteria

Information from the National Library of Medicine

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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
To be recruited by Primary Care Physicians
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023503


Locations
Spain
Research Site
Barcelona, Spain
Sponsors and Collaborators
AstraZeneca
Fundació Institut Català de Farmacologia
More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01023503     History of Changes
Other Study ID Numbers: NIS-CES-CRE-2009/1
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: July 24, 2013
Last Verified: July 2013

Keywords provided by AstraZeneca:
Statins
Dyslipidemia
Spain
Rosuvastatin
Naive
Switching
New statins prescriptions in Spain (naive patients and switching)

Additional relevant MeSH terms:
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