HyperlipidemiasNCT00536965
Percentage of Secondary Prevention Patients Treated to Their LDL-C Targets
An observational study of Hyperlipidemias and Atherosclerosis, run by AstraZeneca at 1 site in Austria.
Trial summary
A cholesterol/lipid profile screening project of high risk patients with hyperlipidaemia (secondary prevention) who already receive cholesterol-lowering therapy. Lipid profile and rate of patients who are treated to target (which is <100mg/dl for patients with high risk and <70mg/dl for patients at very high risk) are… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hyperlipidemias, Atherosclerosis, Coronary Heart Disease
- How many people
- 951 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2007to Dec 2007
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female type II diabetics with: coronary disease with event: acute coronary syndrome, status post MI, PTCT, CABG, angiographically verified), or proven atherosclerotic progression (PAVK min. IIb or S.p. revascularization, stroke/TIA, carotis-plaque: asymptomatic min. 70% or S.p. revascularization)
Who may be able to join
- Secondary prevention patients with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PVD, etc.) and/or diabetes who already receive cholesterol-lowering therapy
Who cannot join
- Patients who do not receive cholesterol-lowering therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional Study Investigating How Effective Secondary Prevention Patients Are Treated to Their LDL-C Targets
A cholesterol/lipid profile screening project of high risk patients with hyperlipidaemia (secondary prevention) who already receive cholesterol-lowering therapy. Lipid profile and rate of patients who are treated to target (which is <100mg/dl for patients with high risk and <70mg/dl for patients at very high risk) are screened (office-based specialists). The doctors therapy decisions after the screening and possible reasons for these decisions will be documented. Our aim is to evaluate dosing habits, to evaluate how many patients are treated to their LDL-C target and to underline the importance of treating patients to their cholesterol targets.
- Conditions
- Hyperlipidemias, Atherosclerosis, Coronary Heart Disease, Carotid Stenosis, Peripheral Vascular Diseases, Diabetes Mellitus
- Keywords
- Hyperlipidemia, Need-to-treat, NIS, Secondary prevention patients with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PVD, etc.) and/or diabetes
- Medical subject headings
- Hyperlipidemias, Atherosclerosis, Coronary Disease, Carotid Stenosis, Peripheral Vascular Diseases, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile
Measured: At screening and 8-5 weeks after screening
HbA1c profile
Measured: At screening and 8-5 weeks after screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies 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
- Prospective
- Enrolment
- 951 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josef Patsch, MD, Study chair, Chair of the Austrian Atheroslerosis SocietyBernhard Foger, MD, Study chair, Co-Chair of the Austrian Atheroslerosis Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536965
- Sponsor's protocol ID
- NIS-CAT-CRE-2007/1
- Status last verified
- Oct 2014
- First submitted
- 27 Sep 2007
- Last updated
- 30 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study Investigating How Effective Secondary Prevention Patients Are Treated to Their LDL-C Targets
- ClinicalTrials.gov ID
- NCT00536965
- Acronym / sponsor ID
- NIS-CAT-CRE-2007/1
- Conditions
- Hyperlipidemias, Atherosclerosis, Coronary Heart Disease, Carotid Stenosis, Peripheral Vascular Diseases, Diabetes Mellitus
- Keywords
- Hyperlipidemia, Need-to-treat, NIS, Secondary prevention patients with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PVD, etc.) and/or diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 951 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 28 Sep 2007 (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.
A cholesterol/lipid profile screening project of high risk patients with hyperlipidaemia (secondary prevention) who already receive cholesterol-lowering therapy. Lipid profile and rate of patients who are treated to target (which is <100mg/dl for patients with high risk and <70mg/dl for patients at very high risk) are screened (office-based specialists). The doctors therapy decisions after the screening and possible reasons for these decisions will be documented. Our aim is to evaluate dosing habits, to evaluate how many patients are treated to their LDL-C target and to underline the importance of treating patients to their cholesterol targets.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female type II diabetics with: coronary disease with event: acute coronary syndrome, status post MI, PTCT, CABG, angiographically verified), or proven atherosclerotic progression (PAVK min. IIb or S.p. revascularization, stroke/TIA, carotis-plaque: asymptomatic min. 70% or S.p. revascularization)
Key inclusion criteria (1 listed)
- Secondary prevention patients with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PVD, etc.) and/or diabetes who already receive cholesterol-lowering therapy
Key exclusion criteria (1 listed)
- Patients who do not receive cholesterol-lowering therapy
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
Lipid profile
Time frame: At screening and 8-5 weeks after screening
HbA1c profile
Time frame: At screening and 8-5 weeks after screening
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 30 Oct 2014.
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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.
Josef Patsch, MD study chair
Chair of the Austrian Atheroslerosis Society
Bernhard Foger, MD study chair
Co-Chair of the Austrian Atheroslerosis Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperlipidemias and Atherosclerosis, run by AstraZeneca at 1 site in Austria.
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 1 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 30 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Lipid profile (time frame: At screening and 8-5 weeks after screening). 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 30 Oct 2014.