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The purpose of the study is to show the compliance rates of the patients to statin treatment and the reasons of non-compliance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Statins | Patients with dyslipidemia who are taking or planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin or generics). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Compliance | Behavioral | Compliance of patients to statin treatment and reasons of compliance or non compliance will be obtained by Patient Reported Outcomes (PROs) every 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Were Compliant With Statin Treatment | 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. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Available Lipid Profiles of Compliant and Non-compliant Participants | Available laboratory measurements of participants were recorded in CRFs. | Month 12 |
| Number of Participants With Reasons of Compliance to Statin Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Mecidiyeköy | Istanbul | 34394 | Turkey (Türkiye) | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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This was an observational study evaluating compliance to statin treatment in participants with dyslipidemia. Data available at each visit was recorded in case report forms (CRFs). No laboratory measurements were performed. The gender of 2 subjects was not recorded.
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| ID | Title | Description |
|---|---|---|
| FG000 | Statins | Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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No biospecimen is retained
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.
| Month 12 |
| Number of Participants With Reasons of Non-compliance to Statin Treatment | Participants were called for a final visit and reasons for non-compliance were recorded. | Month 12 |
| Bolu |
| Turkey (Türkiye) |
| Pfizer Investigational Site | Haseki/Istanbul | 34390 | Turkey (Türkiye) |
| Pfizer Investigational Site | Istanbul | 34098 | Turkey (Türkiye) |
| Pfizer Investigational Site | Istanbul | Turkey (Türkiye) |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Statins | Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex/Gender, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Were Compliant With Statin Treatment | 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. | Primary analysis population: participants diagnosed with dyslipidemia who were taking or planning to take statin treatment. Subset of evaluable participants were analyzed. | Posted | Number | Percentage of participants | Month 12 |
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| Secondary | Available Lipid Profiles of Compliant and Non-compliant Participants | Available laboratory measurements of participants were recorded in CRFs. | Primary analysis population, subset of evaluable participants. | Posted | Mean | Standard Deviation | milligrams per deciliter | Month 12 |
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| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Reasons of Compliance to Statin Treatment | 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. | Primary analysis population. The number of participants with reasons of compliance to statin treatment were not collected or analyzed. | Posted | Month 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Reasons of Non-compliance to Statin Treatment | Participants were called for a final visit and reasons for non-compliance were recorded. | Primary analysis population, subset of evaluable participants | Posted | Number | participants | Month 12 |
|
|
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The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Statins at Visit 2 | Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics). | 0 | 153 | 5 | 153 | ||
| EG001 | Statins at Visit 3 | Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics). | 0 | 76 | 4 | 76 | ||
| EG002 | Statins at Visit 4 | Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics). | 0 | 44 | 4 | 44 | ||
| EG003 | Statins Visit 5 | Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics). | 0 | 268 | 6 | 268 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | MedDRA v11.1 | Systematic Assessment |
| |
| Back pain | General disorders | MedDRA v11.1 | Systematic Assessment |
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| Allergic reaction | General disorders | MedDRA v11.1 | Systematic Assessment |
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| Arthralgia | General disorders | MedDRA v11.1 | Systematic Assessment |
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| Myalgia | General disorders | MedDRA v11.1 | Systematic Assessment |
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| Dizziness | General disorders | MedDRA v11.1 | Systematic Assessment |
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| Constipation | General disorders | MedDRA v11.1 | Systematic Assessment |
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| Dyspepsia | General disorders | MedDRA v11.1 | Systematic Assessment |
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| Nausea | General disorders | MedDRA v11.1 | Systematic Assessment |
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| Gas | General disorders | MedDRA v11.1 | Systematic Assessment |
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| Pharyngitis | General disorders | MedDRA v11.1 | Systematic Assessment |
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| Elevated liver enzyme levels | General disorders | MedDRA v11.1 | Systematic Assessment |
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| Rash on hands | General disorders | MedDRA v11.1 | Systematic Assessment |
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| Cough | General disorders | MedDRA v11.1 | Systematic Assessment |
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| Abdominal discomfort | General disorders | MedDRA v11.1 | Systematic Assessment |
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| Visual impairment | General disorders | MedDRA v11.1 | Systematic Assessment |
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| Renal failure | General disorders | MedDRA v11.1 | Systematic Assessment |
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| Vertigo | General disorders | MedDRA v11.1 | Systematic Assessment |
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| Other | General disorders | MedDRA v11.1 | Systematic Assessment |
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The registered endpoint - observing reasons of compliance or non-compliance to statin treatment - was separated into outcome measure 6 and 7 because observing reasons for compliance with statin treatment were not collected or analyzed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003187 | Compliance |
| ID | Term |
|---|---|
| D004548 | Elasticity |
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
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| Unknown |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Lab parameters were normal in final assessment |
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| Difficulty obtaining prescribed drugs |
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| Forgot to take drug |
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| Don't like taking drugs |
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| Thought it not necessary to take drug |
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| Was late in taking drug |
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| Don't think it necesary to take drug continuously |
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| Don't want to use drugs for a long time |
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| Experienced adverse events (AEs) |
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| Think they are useless |
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| Afraid of becoming an addict |
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| I am resting my liver |
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| Can't take drugs regularly due to high drug price |
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| Other |
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