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Observational Study To Evaluate Statins Patterns Of Use In Spain

This study has suspended participant recruitment.
(Changes affecting Post Authorization Study Regulatory effective from Dec09, impacted the requirements for Spanish studies at National and Regional level.)
Sponsor:
Collaborator:
Fundació Institut Català de Farmacologia
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01023503
First received: October 31, 2009
Last updated: March 8, 2011
Last verified: March 2011
History of Changes
  Purpose

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
Dyslipidemia

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Statins Use Patterns in Spain

Resource links provided by NLM:

MedlinePlus related topics: Statins
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Current and previous hypolipemic treatment, dose and pattern [ Time Frame: Retrospectively (information for the previous 6-months). Information collected once. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Socio-demographic characteristics [ Time Frame: retrospectively ] [ Designated as safety issue: No ]
  • Total Cholesterol, HDL, LDL, Triglycerides, ALAT, Glucose, Creatine Kinase plasma levels [ Time Frame: retrospectively ] [ Designated as safety issue: No ]
  • Concomitant Treatments and Cardiovascular History [ Time Frame: retrospectively ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: March 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Adults, with a new statin prescription or a change in their stain treatment

  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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023503

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

No publications provided

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01023503     History of Changes
Other Study ID Numbers: NIS-CES-CRE-2009/1
Study First Received: October 31, 2009
Last Updated: March 8, 2011
Health Authority: Spain: Ethics Committee
Spain: Spanish Agency of Medicines

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
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013