HypercholesterolaemiaNCT01257971
Non-interventional Study (NIS) to Assess Reaching of Cholesterol Target Values in Patients Treated With HMG-CoA Reductase Inhibitors
An observational study of Hypercholesterolaemia, run by AstraZeneca at 27 sites in Croatia.
Trial summary
This is a multi-centre non-interventional study of patients who are treated with any HMGCoA reductase inhibitor available in Croatia (rosuvastatin, simvastatin, atorvastatin and fluvastatin) for at least 6 months. All HMG-CoA reductase inhibitors must be prescribed in accordance with SmPCs approved in Croatia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolaemia
- How many people
- 1,868 participants
- Where
- 27 sitesCroatia
- Study dates
- Jan 2011to Oct 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: Patients treated by specialist
Who may be able to join
- patients who have been treated with one HMG-CoA reductase inhibitor for at least 6 months without changing the dose for the last 4 weeks at least.
- All patients must sign Informed consent form.
Who cannot join
- Patients who have not signed the Informed consent form.
- Patients with contraindication for the treatment with HMG-CoA reductase inhibitors as per SmPC approved in Croatia.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Croatia27 sites
Research Site
Biograd na Moru
Research Site
Bjelovar
Research Site
Čakovec
Research Site
Crikvenica
Research Site
Dubrovnik
Research Site
Gospić
Research Site
Karlovac
Research Site
Koprivnica
Research Site
Krapina
Research Site
Krapinske Toplice
Research Site
Opatija
Research Site
Osijek
Research Site
Poreč
Research Site
Pula
Research Site
Rijeka
Research Site
Sisak
Research Site
Slavonski Brod
Research Site
Split
Research Site
Stubičke Toplice
Research Site
Umag
Research Site
Vinkovci
Research Site
Virovitica
Research Site
Virovitica- Slatina
Research Site
Vukovar
Research Site
Zadar
Research Site
Zageb
Research Site
Zagreb
About this study
Official title: Non-interventional Study to Assess Reaching of Cholesterol Target Values in Patients Treated With 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) Reductase Inhibitors in Croatia
This is a multi-centre non-interventional study of patients who are treated with any HMGCoA reductase inhibitor available in Croatia (rosuvastatin, simvastatin, atorvastatin and fluvastatin) for at least 6 months. All HMG-CoA reductase inhibitors must be prescribed in accordance with SmPCs approved in Croatia. Data collection for each patient will take place at a single visit. The investigator will complete a Case Report Form with the patient's demographics, the presence of the factors for high cardiovascular risk, current treatment, cholesterol values as well as with further treatment decision.
- Conditions
- Hypercholesterolaemia
- Keywords
- Cholesterol, HMG-CoA reductase inhibitor, cardiovascular risk, LDLl
- 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 hypercholesterolaemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline
Measured: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Percentage of patients reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline
Measured: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Secondary outcomes (6)
Number of patients reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline.
Measured: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Number of patients with high cardiovascular risk reaching the LDL-C goals according to the Fourth Joint European Task Force guideline.
Measured: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Number of patients with high cardiovascular risk reaching the total cholesterol goals according to the Fourth Joint European Task Force guideline.
Measured: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Percentage of patients reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline.
Measured: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Percentage of patients with high cardiovascular risk reaching the LDL-C goals according to the Fourth Joint European Task Force guideline.
Measured: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Percentage of patients with high cardiovascular risk reaching the total cholesterol goals according to the Fourth Joint European Task Force guideline.
Measured: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolaemiaStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,868 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Svjetlana Serdar, Study chair, AstraZenecaKarin Otter, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257971
- Sponsor's protocol ID
- NIS-CHR-CRE-2010/1
- Status last verified
- Mar 2012
- First submitted
- 6 Dec 2010
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study to Assess Reaching of Cholesterol Target Values in Patients Treated With 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) Reductase Inhibitors in Croatia
- ClinicalTrials.gov ID
- NCT01257971
- Acronym / sponsor ID
- NIS-CHR-CRE-2010/1
- Conditions
- Hypercholesterolaemia
- Keywords
- Cholesterol, HMG-CoA reductase inhibitor, cardiovascular risk, LDLl
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,868 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Dec 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.
This is a multi-centre non-interventional study of patients who are treated with any HMGCoA reductase inhibitor available in Croatia (rosuvastatin, simvastatin, atorvastatin and fluvastatin) for at least 6 months. All HMG-CoA reductase inhibitors must be prescribed in accordance with SmPCs approved in Croatia. Data collection for each patient will take place at a single visit. The investigator will complete a Case Report Form with the patient's demographics, the presence of the factors for high cardiovascular risk, current treatment, cholesterol values as well as with further treatment decision.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with hypercholesterolaemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated by specialist
Key inclusion criteria (2 listed)
- patients who have been treated with one HMG-CoA reductase inhibitor for at least 6 months without changing the dose for the last 4 weeks at least.
- All patients must sign Informed consent form.
Key exclusion criteria (2 listed)
- Patients who have not signed the Informed consent form.
- Patients with contraindication for the treatment with HMG-CoA reductase inhibitors as per SmPC approved in Croatia.
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
Number of patients reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline
Time frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Percentage of patients reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline
Time frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
6 secondary outcomes
Number of patients reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline.
Time frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Number of patients with high cardiovascular risk reaching the LDL-C goals according to the Fourth Joint European Task Force guideline.
Time frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Number of patients with high cardiovascular risk reaching the total cholesterol goals according to the Fourth Joint European Task Force guideline.
Time frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Percentage of patients reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline.
Time frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Percentage of patients with high cardiovascular risk reaching the LDL-C goals according to the Fourth Joint European Task Force guideline.
Time frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
Percentage of patients with high cardiovascular risk reaching the total cholesterol goals according to the Fourth Joint European Task Force guideline.
Time frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
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 20 Mar 2012.
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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.
Svjetlana Serdar study chair
AstraZeneca
Karin Otter study director
AstraZeneca
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolaemia, run by AstraZeneca at 27 sites in Croatia.
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 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 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Croatia. 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?
Number of patients reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline (time frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated). The study lists 2 primary outcomes in all. 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 20 Mar 2012.