Observational Study On Compliance Of Statin Treatment Of Patients With High Blood Cholesterol Levels

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00673660
First received: May 1, 2008
Last updated: November 5, 2010
Last verified: December 2009
  Purpose

The purpose of the study is to show the compliance rates of the patients to statin treatment and the reasons of non-compliance.


Condition Intervention
Dyslipidemia
Behavioral: Patient Compliance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment Of Statin Treatment Compliance In Dyslipidemia Patients: An Observational Study

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants Who Were Compliant With Statin Treatment [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
    The physician asked participants about their compliance with medication use, which was defined as not skipping or forgetting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used.


Secondary Outcome Measures:
  • Available Lipid Profiles of Compliant and Non-compliant Participants [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
    Available laboratory measurements of participants were recorded in CRFs.

  • Number of Participants With Reasons of Compliance to Statin Treatment [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Compliance with medication use defined as not skipping or forgeting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used. Participants were called for a final visit . Compliance with drug dosage was recorded.

  • Number of Participants With Reasons of Non-compliance to Statin Treatment [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
    Participants were called for a final visit and reasons for non-compliance were recorded.


Biospecimen Retention:   None Retained

No biospecimen is retained


Enrollment: 375
Study Start Date: October 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Statins
Patients with dyslipidemia who are taking or planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin or generics).
Behavioral: Patient Compliance
Compliance of patients to statin treatment and reasons of compliance or non compliance will be obtained by Patient Reported Outcomes (PROs) every 3 months.

  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

Patients diagnosed with dyslipidemia and taking or planning to take statin treatment. Patients living in the same city of the study center. Patients aged 18 years old and over.

Criteria

Inclusion Criteria:

  • Patients diagnosed with dyslipidemia and taking or planning to take statin treatment.
  • Patients living in the same city of the study center. o Patients aged 18 years and over.

Exclusion Criteria:

  • Patients with severe systemic disease
  • Patients with alcohol and drug addiction and/or mental disease
  • Patients nursing or pregnant, or planning to get pregnant during the study
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673660

Locations
Turkey
Pfizer Investigational Site
Mecidiyekoy, Istanbul, Turkey, 34394
Pfizer Investigational Site
Bolu, Turkey
Pfizer Investigational Site
Haseki/Istanbul, Turkey, 34390
Pfizer Investigational Site
Istanbul, Turkey, 34098
Pfizer Investigational Site
Istanbul, Turkey
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00673660     History of Changes
Other Study ID Numbers: A2581156
Study First Received: May 1, 2008
Results First Received: October 6, 2010
Last Updated: November 5, 2010
Health Authority: Turkey: Ministry of Health

Keywords provided by Pfizer:
Statins
Compliance
Dyslipidemia

Additional relevant MeSH terms:
Dyslipidemias
Hypercholesterolemia
Lipid Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
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 October 19, 2014