High Blood CholesterolCEPHEUSNCT01614561
An Observational Study Evaluating Cholesterol Levels in Patients on Cholesterol Lowering Drugs in Jordan and Lebanon
An observational study of High Blood Cholesterol, run by AstraZeneca.
Trial summary
This was a multicenter survey of patients who were on lipid -lowering pharmacological treatment in 2 Levant countries namely Jordan and Lebanon. The purpose is to study the effects of cholesterol lowering drugs on the blood cholesterol levels of patients in Jordan and Lebanon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Blood Cholesterol
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Dec 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: Patients attending out patient clinics in Jordan and Lebanon
Who may be able to join
- Adult patients with high cholesterol blood levels willing to participate in the study
- Patients must be on cholesterol lowering medications for three months with no dose change for six weeks
Who cannot join
- Patients not on cholesterol lowering medications or on medications for less than three months
- Any medication dose change in six weeks prior to their visit
About this study
Official title: CEPHEUS Centralized Pan-Levant Survey on the Undertreatment of Hypercholesterolemia NIS-LT-CRE-2010/01 Version 1.0
This was a multicenter survey of patients who were on lipid -lowering pharmacological treatment in 2 Levant countries namely Jordan and Lebanon. The purpose is to study the effects of cholesterol lowering drugs on the blood cholesterol levels of patients in Jordan and Lebanon.
Data collected from each patient took place at a single visit. Each participating doctor filled the investigator questionnaire on his/her experience and perception of the management of the hypercholesterolemia of his/her patients. Each doctor was asked to indicate his/her general attitude on the diagnosis of hypercholesterolemia, the existing guidelines and goals and the various treatment options for high cholesterol in blood.
Read more
Before being assessed by the investigator, patients recorded, on the patient questionnaire, their awareness of high blood cholesterol , their current lipid-lowering treatment schedule, their understanding of their condition and compliance in taking the medications on time.
The investigators completed a Patient Record Form (PRF) with the patient's basic information, cardiovascular risk factors and the cardiovascular medical history, current lipid lowering drug treatment and the reason for the current therapy.
A blood sample under fasting condition was drawn from each subject. A central laboratory in Jordan received all samples. Every sample was analyzed for its cholesterol blood level, fasting sugar level and hemoglobin A1C levels.
Read the detailed description
CEPHEUS Centralized Pan-Levant Survey on the Undertreatment of Hypercholesterolemia NIS-LT-CRE-2010/01 Version 1.0
- Conditions
- High Blood Cholesterol
- Keywords
- Hypercholesterolemia, Lipid lowering drugs, Cholesterol level in blood, Target cholesterol levels guidelines for the management of high blood cholesterol
- Medical subject headings
- Hypercholesterolemia
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 NCEP ATP III / updated 2004 NCEP ATP III guidelines, in Jordan and Lebanon
Measured: 5 months- One visit only, no follow up visits
Secondary outcomes (5)
Number and percentage of subjects achieving LDL-C goals according to the NCEP ATP III / 2004 updated NCEP ATP III guidelines, for several subject subsets
Measured: 5 months- One visit only, no follow up visits
Number and percentage of subjects achieving the LDL-C goals, according to the Third Joint European Task Force guidelines, overall and for several subject subsets
Measured: 5 months- One visit only, no follow up visits
Number and percentage of subjects achieving the non HDL-C goals according to the NCEP ATP III / updated 2004 NCEP ATP III / national guidelines (<130 mg/dL), in the following sub-population: patients with fasting triglycerides >200 mg/dL.
Measured: 5 months- One visit only, no follow up visits
Achievement of LDL-C goals, according to the Third Joint European Task Force TJETF / NCEP ATP III / 2004 updated NCEP ATP III guidelines, and patient and physician variables. Assessed using Multivariate logistic regression mode
Measured: 5 months- One visit only, no follow up visits
Physician characteristics associated with the allocation of treatment regimen.
Measured: 5 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 posted8 Jun 2012 (estimated)
- Study startAug 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood CholesterolStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ayman Hammoudeh, MD, Principal investigator, Istishari Hospital Amman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614561
- Sponsor's protocol ID
- NIS-LT-CRE-2010/01
- Acronym
- CEPHEUS
- Status last verified
- Jun 2012
- First submitted
- 1 Jun 2012
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CEPHEUS Centralized Pan-Levant Survey on the Undertreatment of Hypercholesterolemia NIS-LT-CRE-2010/01 Version 1.0
- ClinicalTrials.gov ID
- NCT01614561
- Acronym / sponsor ID
- CEPHEUS / NIS-LT-CRE-2010/01
- Conditions
- High Blood Cholesterol
- Keywords
- Hypercholesterolemia, Lipid lowering drugs, Cholesterol level in blood, Target cholesterol levels guidelines for the management of high blood cholesterol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 Jun 2012 (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 was a multicenter survey of patients who were on lipid -lowering pharmacological treatment in 2 Levant countries namely Jordan and Lebanon. The purpose is to study the effects of cholesterol lowering drugs on the blood cholesterol levels of patients in Jordan and Lebanon.
Data collected from each patient took place at a single visit. Each participating doctor filled the investigator questionnaire on his/her experience and perception of the management of the hypercholesterolemia of his/her patients. Each doctor was asked to indicate his/her general attitude on the diagnosis of hypercholesterolemia, the existing guidelines and goals and the various treatment options for high cholesterol in blood.
Before being assessed by the investigator, patients recorded, on the patient questionnaire, their awareness of high blood cholesterol , their current lipid-lowering treatment schedule, their understanding of their condition and compliance in taking the medications on time.
The investigators completed a Patient Record Form (PRF) with the patient's basic information, cardiovascular risk factors and the cardiovascular medical history, current lipid lowering drug treatment and the reason for the current therapy.
A blood sample under fasting condition was drawn from each subject. A central laboratory in Jordan received all samples. Every sample was analyzed for its cholesterol blood level, fasting sugar level and hemoglobin A1C levels.
Detailed description
CEPHEUS Centralized Pan-Levant Survey on the Undertreatment of Hypercholesterolemia NIS-LT-CRE-2010/01 Version 1.0
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending out patient clinics in Jordan and Lebanon
Key inclusion criteria (2 listed)
- Adult patients with high cholesterol blood levels willing to participate in the study
- Patients must be on cholesterol lowering medications for three months with no dose change for six weeks
Key exclusion criteria (2 listed)
- Patients not on cholesterol lowering medications or on medications for less than three months
- Any medication dose change in six weeks prior to their visit
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 NCEP ATP III / updated 2004 NCEP ATP III guidelines, in Jordan and Lebanon
Time frame: 5 months- One visit only, no follow up visits
5 secondary outcomes
Number and percentage of subjects achieving LDL-C goals according to the NCEP ATP III / 2004 updated NCEP ATP III guidelines, for several subject subsets
Time frame: 5 months- One visit only, no follow up visits
Number and percentage of subjects achieving the LDL-C goals, according to the Third Joint European Task Force guidelines, overall and for several subject subsets
Time frame: 5 months- One visit only, no follow up visits
Number and percentage of subjects achieving the non HDL-C goals according to the NCEP ATP III / updated 2004 NCEP ATP III / national guidelines (<130 mg/dL), in the following sub-population: patients with fasting triglycerides >200 mg/dL.
Time frame: 5 months- One visit only, no follow up visits
Achievement of LDL-C goals, according to the Third Joint European Task Force TJETF / NCEP ATP III / 2004 updated NCEP ATP III guidelines, and patient and physician variables. Assessed using Multivariate logistic regression mode
Time frame: 5 months- One visit only, no follow up visits
Physician characteristics associated with the allocation of treatment regimen.
Time frame: 5 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 8 Jun 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.
Ayman Hammoudeh, MD principal investigator
Istishari Hospital Amman
Questions about this trial
What is this clinical trial studying?
An observational study of High Blood Cholesterol, 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 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 8 Jun 2012. 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 NCEP ATP III / updated 2004 NCEP ATP III guidelines, in Jordan and Lebanon (time frame: 5 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 8 Jun 2012.