HypercholesterolemiaCEPHEUSNCT01243255
Polish Survey on the Efficacy of the Hypercholesterolemia Treatment
An observational study of Hypercholesterolemia, run by AstraZeneca.
Trial summary
The purpose of the survey is to evaluate the efficacy of treatment of hypercholesterolemia in Polish patients who are currently on lipid- lowering pharmacological therapy . Efficient treatment is defined as achievement of the LDL cholesterol level goals according to the European Society of Cardiology 2007 guidlines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Primary care clinic
Who may be able to join
- Patients on lipid lowering drug treatment
- Lipid lowering drug treatment lasting at least 3 months
- No lipid lowering drug/dose change for a minimum 6 weeks prior to enrolment to the study
Who cannot join
- Lack of patient's signed informed consent form
- Lack of the blood sample taken for lipid profile and glucose within 10 days before or after assessment of the patient
About this study
Official title: Centralized Pan-European Survey on the Undertreatment of Hypercholesterolemia. Polish Survey on the Efficacy of the Hypercholesterolemia Treatment
The purpose of the survey is to evaluate the efficacy of treatment of hypercholesterolemia in Polish patients who are currently on lipid- lowering pharmacological therapy . Efficient treatment is defined as achievement of the LDL cholesterol level goals according to the European Society of Cardiology 2007 guidlines.
- Conditions
- Hypercholesterolemia
- Keywords
- hypercholesterolemia, low density lipoprotein, undertreatment of hypercholesterolemia
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with hypercholesterolemia on lipid lowering pharmacological treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
establish the proportion of patients on lipid lowering pharmacological treatment reaching the LDL-C goals according to ESC 2007 guidelines in general.
Measured: whole study procedure takes place during the one, single patient's visit
Secondary outcomes (3)
establish the proportion of patients on lipid lowering pharmacological treatment in primary prevention, reaching the LDL-C goals according to ESC 2007 guidelines for this sub-population
Measured: whole study procedure takes place during the one, single patient's visit
establish the proportion of patients on lipid lowering pharmacological treatment in secondary prevention, reaching the LDL-C goals according to ESC 2007 guidelines for this sub-population
Measured: whole study procedure takes place during the one, single patient's visit
identify determinants (patient and physician characteristics) for undertreatment of hypercholesterolemia.
Measured: whole study procedure takes place during the one, single patient's visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Artur Mamcarz, Principal investigator, Medical University of WarsawBarbara Możejko-Pastewka, Study director, AstraZeneca Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243255
- Sponsor's protocol ID
- NIS-CPL-DUM-2010/1
- Acronym
- CEPHEUS
- Status last verified
- Apr 2012
- First submitted
- 17 Nov 2010
- Last updated
- 4 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centralized Pan-European Survey on the Undertreatment of Hypercholesterolemia. Polish Survey on the Efficacy of the Hypercholesterolemia Treatment
- ClinicalTrials.gov ID
- NCT01243255
- Acronym / sponsor ID
- CEPHEUS / NIS-CPL-DUM-2010/1
- Conditions
- Hypercholesterolemia
- Keywords
- hypercholesterolemia, low density lipoprotein, undertreatment of hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 18 Nov 2010 (estimated)
- Results
- Not posted in the source record
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 survey is to evaluate the efficacy of treatment of hypercholesterolemia in Polish patients who are currently on lipid- lowering pharmacological therapy . Efficient treatment is defined as achievement of the LDL cholesterol level goals according to the European Society of Cardiology 2007 guidlines.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with hypercholesterolemia on lipid lowering pharmacological treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (3 listed)
- Patients on lipid lowering drug treatment
- Lipid lowering drug treatment lasting at least 3 months
- No lipid lowering drug/dose change for a minimum 6 weeks prior to enrolment to the study
Key exclusion criteria (2 listed)
- Lack of patient's signed informed consent form
- Lack of the blood sample taken for lipid profile and glucose within 10 days before or after assessment of the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
establish the proportion of patients on lipid lowering pharmacological treatment reaching the LDL-C goals according to ESC 2007 guidelines in general.
Time frame: whole study procedure takes place during the one, single patient's visit
3 secondary outcomes
establish the proportion of patients on lipid lowering pharmacological treatment in primary prevention, reaching the LDL-C goals according to ESC 2007 guidelines for this sub-population
Time frame: whole study procedure takes place during the one, single patient's visit
establish the proportion of patients on lipid lowering pharmacological treatment in secondary prevention, reaching the LDL-C goals according to ESC 2007 guidelines for this sub-population
Time frame: whole study procedure takes place during the one, single patient's visit
identify determinants (patient and physician characteristics) for undertreatment of hypercholesterolemia.
Time frame: whole study procedure takes place during the one, single patient's visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2012.
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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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.
Prof. Artur Mamcarz principal investigator
Medical University of Warsaw
Barbara Możejko-Pastewka study director
AstraZeneca Pharma
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by AstraZeneca.
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 3 inclusion and 2 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 4 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
establish the proportion of patients on lipid lowering pharmacological treatment reaching the LDL-C goals according to ESC 2007 guidelines in general. (time frame: whole study procedure takes place during the one, single patient's visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2012.