HypercholesterolemiaCEPHEUSNCT00687492
Centralized Pan-Asian Survey on the Under Treatment of Hypercholesterolemia
An observational study of Hypercholesterolemia, run by AstraZeneca at 59 sites in 8 countries.
Trial summary
The survey will try to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the third NCEP ATP guidelines, overall and by country. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- How many people
- 8,000 participants
- Where
- 59 sitesin 8 countries
- Study dates
- May 2008to Dec 2008
- 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 had to be on a 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
- 2 or more risk factors (according to NCEP ATP III guideline)
- Receiving lipid-lowering drug treatment for at least 3 months without dosage change for a minimum of 6 weeks.
Who cannot join
- Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site).
- Previous enrolment or randomisation of treatment in the present study.
- Participation in a clinical study during the last 90 days.
Trial locations and contacts
59 sites in 8 countries.
59 sites in 8 countries
Malaysia19 sites
Research Site
Ampang, Selangor
Research Site
Bangsar, Kuala Lumpur
Research Site
Batu Caves, Selangor
Research Site
Hulu Selangor, Selangor
Research Site
Kampung Baru Subang, Selangor
Research Site
Kepong, Kuala Lumpur
Research Site
Klang, Selangor
Research Site
Kuala Lumpur, Kuala Lumpur
Research Site
Kuala Selangor, Selangor
Research Site
Petaling Jaya, Selangor
Research Site
Port Klang, Selangor
Research Site
Puchong, Kuala Lumpur
Research Site
Sekinchan, Selangor
Research Site
Seri Kembangan, Selangor
Research Site
Setapak, Kuala Lumpur
Research Site
Shah Alam, Selangor
Research Site
Subang Jaya, Selangor
Research Site
Sungai Buloh, Selangor
Research Site
Sunway City, Selangor
South Korea15 sites
Research Site
Bucheon-si, Gyeonggi-do
Research Site
Bundang, Gyeonggi-do
Research Site
Busan
Research Site
Cheonan, Chung-Cheong-nam-do
Research Site
Daegu
Research Site
Daejeon
Research Site
Guri-si, Gyeonggi-do
Research Site
Gwangju
Research Site
Il-san, Gyeonggi-do
Research Site
Incheon
Research Site
Jeju City
Research Site
Masan, Gyung-sang-nam-do
Research Site
Seoul
Research Site
Suwon, Gyeonggi-do
Research Site
Ulsan
Indonesia6 sites
Research Site
Bandung, West Java
Research Site
Jakarta, DKI Jakarta
Research Site
Medan, North Sumatra
Research Site
Semarang, Central Java
Research Site
Sidoarjo, East Java
Research Site
Surabaya, East Java
Thailand6 sites
Research Site
Bangkoknoi, Bangkok
Research Site
Dusit, Bangkok
Research Site
Klongluang, Changwat Pathum Thani
Research Site
Muang, ChiangMai
Research Site
Pathumwan, Bangkok
Research Site
Ratchathewi, Bangkok
Philippines5 sites
Research Site
Baguio City, Benguet
Research Site
Davao City, Davao Region
Research Site
Iloilo City, Iloilo
Research Site
Lipa, Batangas
Research Site
Manila, Manila
Taiwan5 sites
Research Site
Kaohsiung City
Research Site
Taichung
Research Site
Tainan
Research Site
Taipei
Research Site
Taoyuan
About this study
The survey will try to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the third NCEP ATP guidelines, overall and by country.
- Conditions
- Hypercholesterolemia
- Keywords
- hypercholesterolemia, NCEP ATP III guidelines, survey
- Medical subject headings
- Hypercholesterolemia
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and percentage of subjects achieving the LDL-C goals according to updated 2004 NCEP ATP Ⅲ guidelines(overall and by country)
Measured: After collecting all Patient Record Form.
Secondary outcomes (3)
The number and percentage of subjects achieving the LDL-C goals according to the updated 2004 NCEP ATP Ⅲ guidelines for several subject subsets.
Measured: After collecting all Patient Record Form.
The association between achievement of LDL-C goals,according to the updated 2004 NCEP ATPⅢ guidelines and patient and physician variables.
Measured: After collecting all Patient Record Form.
The physician characteristics associated with the allocation of hypercholesterolemia treatment regime.
Measured: After collecting all Patient Record Form.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2008
- Study completionDec 2008
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Park Jeong Euy, Principal investigator, Sungkyunkwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687492
- Sponsor's protocol ID
- NIS-CAP-DUM-2008/1
- Acronym
- CEPHEUS
- Status last verified
- Dec 2010
- First submitted
- 28 May 2008
- Last updated
- 2 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centralized Pan-Asian Survey on the Under Treatment of Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00687492
- Acronym / sponsor ID
- CEPHEUS / NIS-CAP-DUM-2008/1
- Conditions
- Hypercholesterolemia
- Keywords
- hypercholesterolemia, NCEP ATP III guidelines, survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 30 May 2008 (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.
The survey will try to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the third NCEP ATP guidelines, overall and by country.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients had to be on a lipid-lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.
Key inclusion criteria (2 listed)
- 2 or more risk factors (according to NCEP ATP III guideline)
- Receiving lipid-lowering drug treatment for at least 3 months without dosage change for a minimum of 6 weeks.
Key exclusion criteria (3 listed)
- Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site).
- Previous enrolment or randomisation of treatment in the present study.
- Participation in a clinical study during the last 90 days.
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 subjects achieving the LDL-C goals according to updated 2004 NCEP ATP Ⅲ guidelines(overall and by country)
Time frame: After collecting all Patient Record Form.
3 secondary outcomes
The number and percentage of subjects achieving the LDL-C goals according to the updated 2004 NCEP ATP Ⅲ guidelines for several subject subsets.
Time frame: After collecting all Patient Record Form.
The association between achievement of LDL-C goals,according to the updated 2004 NCEP ATPⅢ guidelines and patient and physician variables.
Time frame: After collecting all Patient Record Form.
The physician characteristics associated with the allocation of hypercholesterolemia treatment regime.
Time frame: After collecting all Patient Record Form.
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 2 Dec 2010.
Related trials for Hypercholesterolemia
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Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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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.
Park Jeong Euy principal investigator
Sungkyunkwan University
59 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by AstraZeneca at 59 sites in 8 countries.
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 3 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 2 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in Malaysia, South Korea, Indonesia, Thailand, Philippines and 3 more countries. 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 subjects achieving the LDL-C goals according to updated 2004 NCEP ATP Ⅲ guidelines(overall and by country) (time frame: After collecting all Patient Record Form.). 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 2 Dec 2010.