DyslipidemiaNCT00673660

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

An observational study of Dyslipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 5 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Dyslipidemia
What is being tested?: Patient Compliance
Type of treatment: Lifestyle or therapy programme
How many people: 375 participants
Where: 5 sitesTurkey (Türkiye)
Study dates: Oct 2007to Oct 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Turkey (Türkiye)5 sites

Pfizer Investigational Site
Bolu
Pfizer Investigational Site
Haseki/Istanbul, 34390
Pfizer Investigational Site
Istanbul, 34098
Pfizer Investigational Site
Istanbul
Pfizer Investigational Site
Mecidiyeköy, Istanbul, 34394

Other trials in Turkey (Türkiye)

About this study

Official title: Assessment Of Statin Treatment Compliance In Dyslipidemia Patients: An Observational Study

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

Conditions: Dyslipidemia
Being tested: Patient Compliance
Keywords: Statins, Compliance, Dyslipidemia
Medical subject headings: Dyslipidemias, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Patient ComplianceBehavioural
Compliance of patients to statin treatment and reasons of compliance or non compliance will be obtained by Patient Reported Outcomes (PROs) every 3 months.

Study groups in NCT00673660
Study group	Role	What they receive
Statins		Patients with dyslipidemia who are taking or planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin or generics). Receives: Behavioral: Patient Compliance

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Month 12

Secondary outcomes (3)

Available Lipid Profiles of Compliant and Non-compliant Participants
Available laboratory measurements of participants were recorded in CRFs.
Measured: Month 12
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.
Measured: 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.
Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Oct 2009

First posted7 May 2008 (estimated)
Study startOct 2007
Primary completionOct 2009
Study completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DyslipidemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 375 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00673660
Sponsor's protocol ID: A2581156
Status last verified: Feb 2021
First submitted: 1 May 2008
Last updated: 21 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dyslipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment Of Statin Treatment Compliance In Dyslipidemia Patients: An Observational Study
ClinicalTrials.gov ID: NCT00673660
Acronym / sponsor ID: A2581156
Conditions: Dyslipidemia
Keywords: Statins, Compliance, Dyslipidemia
Study type: Observational
Recruitment status: Completed
Enrolment: 375 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 7 May 2008 (estimated)
Results: Posted 4 Nov 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Statins	–	Behavioral: Patient CompliancePatients with dyslipidemia who are taking or planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin or generics).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Patient ComplianceCompliance of patients to statin treatment and reasons of compliance or non compliance will be obtained by Patient Reported Outcomes (PROs) every 3 months.	Behavioural	Statins

Primary outcome

Percentage of Participants Who Were Compliant With Statin Treatment
Time frame: Month 12
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.

3 secondary outcomes

Available Lipid Profiles of Compliant and Non-compliant Participants
Time frame: Month 12
Number of Participants With Reasons of Compliance to Statin Treatment
Time frame: Month 12
Number of Participants With Reasons of Non-compliance to Statin Treatment
Time frame: Month 12

Results and safety

Results posted to the registry on 4 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Statins	375	268

Primary outcome: Percentage of Participants Who Were Compliant With Statin Treatment

Time frame: Month 12. Number. Unit: Percentage of participants

Measure	Statins n = 375
Value	86.7

Population analysed: Primary analysis population: participants diagnosed with dyslipidemia who were taking or planning to take statin treatment. Subset of evaluable participants were analyzed.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Statins at Visit 2	0 of 153 (0%)	5 of 153 (3.3%)	Not reported
Statins at Visit 3	0 of 76 (0%)	4 of 76 (5.3%)	Not reported
Statins at Visit 4	0 of 44 (0%)	4 of 44 (9.1%)	Not reported
Statins Visit 5	0 of 268 (0%)	6 of 268 (2.2%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Dyslipidemia

Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
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Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
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Not yet recruitingPhase 2
Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Dyslipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 5 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Were Compliant With Statin Treatment (time frame: Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00673660.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.