Observational Study On Compliance Of Statin Treatment Of Patients With High Blood Cholesterol Levels
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00673660
First received: May 1, 2008
Last updated: November 5, 2010
Last verified: December 2009
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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
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:
|
Hypercholesterolemia Dyslipidemias Hyperlipidemias 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 May 16, 2013