HypercholesterolemiaCEPHEUSNCT01768403
Centralised Pan-Algerian Survey on the Undertreatment of Hypercholesterolemia
An observational study of Hypercholesterolemia and Cardiovascular Disease, run by AstraZeneca.
Trial summary
Centralized Pan-Algerian Survey on the undertreatment of hypercholesterolemia. The purpose of this study is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Third Joint European Task Force guidelines in the survey population. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypercholesterolemia, Cardiovascular Disease, Hypertension
- How many people
- 1,236 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Mar 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Subject must be 19 years of age or older of either gender or race. * Subject must provide informed consent and comply with the survey procedures. * Subject is on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks
Who may be able to join
- Subject must provide informed consent and comply with the survey procedures.
- Subject is on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.
Who cannot join
- Subjects who are unwilling or unable to provide informed consent.
About this study
Centralized Pan-Algerian Survey on the undertreatment of hypercholesterolemia. The purpose of this study is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Third Joint European Task Force guidelines in the survey population.
Read the detailed description
Centralised Pan-Algerian Survey on the undertreatment of hypercholesterolemia.
- Conditions
- Hypercholesterolemia, Cardiovascular Disease, Hypertension, Diabetes, Coronary Heart Disease, Peripheral Arterial Disease
- Keywords
- Hypercholesterolemia, Cardiovascular disease, Hypertension, Coronary Heart disease, Peripheral Arterial disease
- Medical subject headings
- Hypercholesterolemia, Cardiovascular Diseases, Hypertension, Diabetes Mellitus, Coronary Disease, Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of subjects achieving the LDL-C goals, according to the Third Joint European Task Force (TJETF) guidelines.
Measured: 24 weeks
Secondary outcomes (4)
Number and percentage of subjects achieving LDL-C goals according to the TJETF guidelines.
In the following sub-populations: - Patients with / or not with metabolic syndrome (according to NCEP III definition), - Primary/secondary prevention patients
Measured: 24 weeks
Number and percentage of subjects achieving LDL-C goals according to the NCEP ATP III/2004 updated NCEP ATP III and to the 2005 AFSSAPS guidelines
Overall and in the following sub-populations: Patients with/or without metabolic syndrome-Iary/IIary preven
Measured: 24 weeks
Number and percentage of subjects achieving LDL-C goals according to the : TJETF / NCEP ATP III and 2004 updated NCEP ATP III guidelines.
For the following sub-populations: Demographic variables, CV risk factors \& Lipid-lowering agent class
Measured: 24 weeks
The association between achievement of LDL-C goals, according to the Third Joint European Task Force / NCEP ATP III / 2004 updated NCEP ATP III guidelines, and patient and physician variables, assessed by multivariate logistic regression models
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startSep 2010
- Primary completionMar 2011
- Study completionMar 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,236 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Habib BENNACEUR, MD, Study chair, AstraZenecaNawel BOUTEKDJIRET, MD, Study director, AstraZenecaYassin BOUHOUITA-GUERMECH, Professor, Principal investigator, Cardiology department /Mustapha Bacha Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768403
- Sponsor's protocol ID
- NIS-CDZ-XXX-2012/1
- Acronym
- CEPHEUS
- Status last verified
- Jan 2013
- First submitted
- 14 Jan 2013
- Last updated
- 15 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centralised Pan-Algerian Survey on the Undertreatment of Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT01768403
- Acronym / sponsor ID
- CEPHEUS / NIS-CDZ-XXX-2012/1
- Conditions
- Hypercholesterolemia, Cardiovascular Disease, Hypertension, Diabetes, Coronary Heart Disease, Peripheral Arterial Disease
- Keywords
- Hypercholesterolemia, Cardiovascular disease, Hypertension, Coronary Heart disease, Peripheral Arterial disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,236 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 15 Jan 2013 (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.
Centralized Pan-Algerian Survey on the undertreatment of hypercholesterolemia. The purpose of this study is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Third Joint European Task Force guidelines in the survey population.
Detailed description
Centralised Pan-Algerian Survey on the undertreatment of hypercholesterolemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Subject must be 19 years of age or older of either gender or race. * Subject must provide informed consent and comply with the survey procedures. * Subject is on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks
Key inclusion criteria (2 listed)
- Subject must provide informed consent and comply with the survey procedures.
- Subject is on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.
Key exclusion criteria (1 listed)
- Subjects who are unwilling or unable to provide informed consent.
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 and percentage of subjects achieving the LDL-C goals, according to the Third Joint European Task Force (TJETF) guidelines.
Time frame: 24 weeks
4 secondary outcomes
Number and percentage of subjects achieving LDL-C goals according to the TJETF guidelines.
Time frame: 24 weeks
Number and percentage of subjects achieving LDL-C goals according to the NCEP ATP III/2004 updated NCEP ATP III and to the 2005 AFSSAPS guidelines
Time frame: 24 weeks
Number and percentage of subjects achieving LDL-C goals according to the : TJETF / NCEP ATP III and 2004 updated NCEP ATP III guidelines.
Time frame: 24 weeks
The association between achievement of LDL-C goals, according to the Third Joint European Task Force / NCEP ATP III / 2004 updated NCEP ATP III guidelines, and patient and physician variables, assessed by multivariate logistic regression models
Time frame: 24 weeks
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 15 Jan 2013.
Related trials for Hypercholesterolemia
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.
Habib BENNACEUR, MD study chair
AstraZeneca
Nawel BOUTEKDJIRET, MD study director
AstraZeneca
Yassin BOUHOUITA-GUERMECH, Professor principal investigator
Cardiology department /Mustapha Bacha Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia and Cardiovascular Disease, 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 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 15 Jan 2013. 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?
Number and percentage of subjects achieving the LDL-C goals, according to the Third Joint European Task Force (TJETF) guidelines. (time frame: 24 weeks). 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 15 Jan 2013.