DyslipidemiaCEPHEUSNCT01075594
Study of Undertreatment of Patients With Dyslipidemia in Bulgaria
An observational study of Dyslipidemia, run by AstraZeneca at 15 sites in Bulgaria.
Trial summary
The purpose of this study is to establish the proportion of Bulgarian patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Fourth Joint European Task Force guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemia
- How many people
- 2,500 participants
- Where
- 15 sitesBulgaria
- Study dates
- Feb 2010to Aug 2010
- 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
- Lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks
- Signed Informed Consent
Who cannot join
- Informed Consent not provided
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Bulgaria15 sites
Research Site
Blagoevgrad
Research Site
Burgas
Research Site
Haskovo
Research Site
Montana
Research Site
Pazardzhik
Research Site
Pleven
Research Site
Plovdiv
Research Site
Rousse
Research Site
Shumen
Research Site
Sliven
Research Site
Smolyan
Research Site
Sofia
Research Site
Stara Zagora
Research Site
Varna
Research Site
Veliko Tarnovo
About this study
Official title: Centralized Pan-Bulgarian Survey on the Undertreatment of Hypercholesterolemia
The purpose of this study is to establish the proportion of Bulgarian patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Fourth Joint European Task Force guidelines.
- Conditions
- Dyslipidemia
- Keywords
- Dyslipidemia, Target cholesterol, Undertreatment
- Medical subject headings
- Dyslipidemias
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 dyslipidemia on lipid lowering therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and percentage of patients achieving the LDL-C goals, according to the Fourth Joint European Task Force guidelines
Measured: 6 months - one visit only, no follow-up visits
Secondary outcomes (3)
The number and percentage of subjects achieving the LDL-C goals, according to the Fourth Joint European Task Force guidelines for several subject subsets
Measured: 6 months - one visit only, no follow-up visits
The number and percentage of subjects achieving LDL-C goals according to the NCEP ATP III / 2004 updated 2004 NCEP ATP III guidelines, overall and for several subject subsets
Measured: 6 months - one visit only, no follow-up visits
The number and percentage of subjects achieving the non HDL-C goals according to the NCEP ATP III/updated 2004 NCEP ATP III/national guidelines [<130mg/dL (3,37mmol/L)], in the following sub-population: patients with fasting triglycerides >200 mg/dL
Measured: 6 months - one visit only, no follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075594
- Sponsor's protocol ID
- NIS-CBG-CRE-2009/1
- Acronym
- CEPHEUS
- Status last verified
- Sep 2010
- First submitted
- 19 Feb 2010
- Last updated
- 10 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centralized Pan-Bulgarian Survey on the Undertreatment of Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT01075594
- Acronym / sponsor ID
- CEPHEUS / NIS-CBG-CRE-2009/1
- Conditions
- Dyslipidemia
- Keywords
- Dyslipidemia, Target cholesterol, Undertreatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 25 Feb 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 this study is to establish the proportion of Bulgarian patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Fourth Joint European Task Force guidelines.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with dyslipidemia on lipid lowering therapy |
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 (2 listed)
- Lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks
- Signed Informed Consent
Key exclusion criteria (1 listed)
- Informed Consent not provided
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
The number and percentage of patients achieving the LDL-C goals, according to the Fourth Joint European Task Force guidelines
Time frame: 6 months - one visit only, no follow-up visits
3 secondary outcomes
The number and percentage of subjects achieving the LDL-C goals, according to the Fourth Joint European Task Force guidelines for several subject subsets
Time frame: 6 months - one visit only, no follow-up visits
The number and percentage of subjects achieving LDL-C goals according to the NCEP ATP III / 2004 updated 2004 NCEP ATP III guidelines, overall and for several subject subsets
Time frame: 6 months - one visit only, no follow-up visits
The number and percentage of subjects achieving the non HDL-C goals according to the NCEP ATP III/updated 2004 NCEP ATP III/national guidelines [<130mg/dL (3,37mmol/L)], in the following sub-population: patients with fasting triglycerides >200 mg/dL
Time frame: 6 months - one visit only, no follow-up visits
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 10 Sep 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 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 AstraZeneca at 15 sites in Bulgaria.
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 1 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 10 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Bulgaria. 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?
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?
The number and percentage of patients achieving the LDL-C goals, according to the Fourth Joint European Task Force guidelines (time frame: 6 months - one visit only, no follow-up visits). 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 10 Sep 2010.