HypercholesterolaemiaNCT01483950
Evaluation of Patients Treated With HMG-CoA Reductase Inhibitors to Reach Cholesterol Target Values
An observational study of Hypercholesterolaemia, run by AstraZeneca at 14 sites in Bosnia and Herzegovina.
Trial summary
This study is non-interventional study of patients who are treated with any HMGCoA reductase inhibitors (rosuvastatin, simvastatin,atorvastatin and fluvastatin) available in Bosnia and Herzegovina for at least 6 months. Data collection for each patient will take place at a single visit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolaemia
- How many people
- 800 participants
- Where
- 14 sitesBosnia and Herzegovina
- Study dates
- Apr 2012to Jan 2013
- 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, treated with one HMG-CoA reductase inhibitors 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 Bosnia and Herzegovina
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Bosnia and Herzegovina14 sites
Research Site
Banja Luka
Research Site
Bijeljina
Research Site
Doboj
Reserach Site
Gradiska
Research Site
Kakanj
Research Site
Maglaj
Research Site
Prijedor
Research Site
Sarajevo
Research Site
Tešanj
Research Site
Trebinje
Research Site
Visoko
Research Site
Zavidovići
Research Site
Zenica
Research Site
Zvornik
About this study
Official title: Non-interventional Study to Assess Reaching of Cholesterol Target Values in Patients Treated With HMG-CoA Reductase Inhibitors in Bosnia and Herzegovina
This study is non-interventional study of patients who are treated with any HMGCoA reductase inhibitors (rosuvastatin, simvastatin,atorvastatin and fluvastatin) available in Bosnia and Herzegovina for at least 6 months. Data collection for each patient will take place at a single visit. The investigators will complete Case Report Form (CRF) with patient's demographic, the presence of the factors for high cardiovascular risk, current treatment, cholesterol value as well as with further treatment decision.
Read the detailed description
Non-interventional study to assess reaching of cholesterol target values in patients treated with HMG-CoA reductase inhibitors in Bosnia and Herzegovina
- Conditions
- Hypercholesterolaemia
- Keywords
- Dyslipidemia, Statins, Total Cholesterol, Low density lipoprotein (LDL) cholesterol, High density lipoprotein (HDL) cholesterol
- Medical subject headings
- Hypercholesterolemia, 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 |
|---|---|---|
| Patients with hypercholesterolaemia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and 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 (3)
The number and 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
The number and 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
The number and 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 posted2 Dec 2011 (estimated)
- Study startApr 2012
- Primary completionJan 2013
- Study completionJan 2013
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
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vesna Loza, DOC. DR. SCI. MED, Principal investigator, Klinika za bolesti srca i reumatizma Sarajevo , Bosnia and HerzegovinaMeta Jeras, MR PH, Study director, West Balkan MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483950
- Sponsor's protocol ID
- NIS-CBA-CRE-2011/1
- Status last verified
- Feb 2013
- First submitted
- 30 Nov 2011
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. 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 HMG-CoA Reductase Inhibitors in Bosnia and Herzegovina
- ClinicalTrials.gov ID
- NCT01483950
- Acronym / sponsor ID
- NIS-CBA-CRE-2011/1
- Conditions
- Hypercholesterolaemia
- Keywords
- Dyslipidemia, Statins, Total Cholesterol, Low density lipoprotein (LDL) cholesterol, High density lipoprotein (HDL) cholesterol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 2 Dec 2011 (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 study is non-interventional study of patients who are treated with any HMGCoA reductase inhibitors (rosuvastatin, simvastatin,atorvastatin and fluvastatin) available in Bosnia and Herzegovina for at least 6 months. Data collection for each patient will take place at a single visit. The investigators will complete Case Report Form (CRF) with patient's demographic, the presence of the factors for high cardiovascular risk, current treatment, cholesterol value as well as with further treatment decision.
Detailed description
Non-interventional study to assess reaching of cholesterol target values in patients treated with HMG-CoA reductase inhibitors in Bosnia and Herzegovina
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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, treated with one HMG-CoA reductase inhibitors 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 Bosnia and Herzegovina
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 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
3 secondary outcomes
The number and 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
The number and 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
The number and 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 5 Feb 2013.
Related trials for Hypercholesterolaemia
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
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
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.
Vesna Loza, DOC. DR. SCI. MED principal investigator
Klinika za bolesti srca i reumatizma Sarajevo , Bosnia and Herzegovina
Meta Jeras, MR PH study director
West Balkan MD
14 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 14 sites in Bosnia and Herzegovina.
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 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Bosnia and Herzegovina. 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 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). 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 5 Feb 2013.