DyslipidemiaDEMANDNCT01265836
Dyslipidemia Treatment in Thailand and Cardiovascular Outcomes
An observational study of Dyslipidemia, run by AstraZeneca.
Trial summary
The purpose of this study is to establish the proportion of patients on lipid-lowering pharmacological treatment (statin or combination) reaching the LDL-C goals according to the updated 2004 National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemia
- How many people
- 1,064 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Mar 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: 1. Provision of subject informed consent 2. Female or male aged = 18 years 3. Patients eligible for treatment of dyslipidemia with statins, according to the current guidelines NCEP ATPIII about Dyslipidemias and Atherosclerosis Prevention. 4. Receiving lipid-lowering drug treatment for at least 15 days.
Who may be able to join
- Provision of subject informed consent, Female or male aged = 18 years
- Patients eligible for treatment of dyslipidemia with statins, according to the current guidelines NCEP ATPIII about Dyslipidemias and Atherosclerosis Prevention Receiving lipid-lowering drug treatment for at least 15 days.
Who cannot join
- Involvement in the planning and conduct of the study (applies to either 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
About this study
The purpose of this study is to establish the proportion of patients on lipid-lowering pharmacological treatment (statin or combination) reaching the LDL-C goals according to the updated 2004 National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guidelines.
Read the detailed description
MC MD
- Conditions
- Dyslipidemia
- Keywords
- Dyslipidemia Treatment and Cardiovascular Outcomes
- Medical subject headings
- 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 |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number (#) of subjects achieving the LDL-C goals according to updated 2004 NCEP ATP III guidelines.
Measured: 1 year
The percent (%) of subjects achieving the LDL-C goals according to updated 2004 NCEP ATP III guidelines.
Measured: 1 year
Secondary outcomes (6)
The number of subjects achieving the LDL-C goals according to the updated 2004 NCEP ATP III guidelines for several subject subsets
Measured: 1 year
The number of the secondary event rate of cerebrovascular patients on lipid-lowering pharmacological treatment (statin or combination) who reaching and non-reaching the LDL-C goals according to the updated 2004 NCEP ATP III guidelines for 1
Measured: 1 year
The number of the secondary event rate cardiovascular patients on lipid-lowering pharmacological treatment (statin or combination) who reaching and non-reaching the LDL-C goals according to the updated 2004 NCEP ATP III guidelines for 1 year
Measured: 1 year
The percentage of subjects achieving the LDL-C goals according to the updated 2004 NCEP ATP III guidelines for several subject subsets
Measured: 1 year
The percent of the secondary event rate of cerebrovascular patients on lipid-lowering pharmacological treatment (statin or combination) who reaching and non-reaching the LDL-C goals according to the updated 2004 NCEP ATP III guidelines for 1
Measured: 1 year
The percent of the secondary event rate cardiovascular patients on lipid-lowering pharmacological treatment (statin or combination) who reaching and non-reaching the LDL-C goals according to the updated 2004 NCEP ATP III guidelines for 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startMar 2011
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- 1,064 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Apichard Sukonthasarn, Prof.M.D., Principal investigator, Maharaj Nakorn Chiangmai Hospital Cardiovascular division, Department of Internal Medicine, Faculty of Medicine, Chiangmai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265836
- Sponsor's protocol ID
- NIS-CTH-DUM-2010/1
- Acronym
- DEMAND
- Status last verified
- Apr 2011
- First submitted
- 14 Dec 2010
- Last updated
- 12 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyslipidemia Treatment in Thailand and Cardiovascular Outcomes
- ClinicalTrials.gov ID
- NCT01265836
- Acronym / sponsor ID
- DEMAND / NIS-CTH-DUM-2010/1
- Conditions
- Dyslipidemia
- Keywords
- Dyslipidemia Treatment and Cardiovascular Outcomes
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 1,064 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 23 Dec 2010 (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 purpose of this study is to establish the proportion of patients on lipid-lowering pharmacological treatment (statin or combination) reaching the LDL-C goals according to the updated 2004 National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guidelines.
Detailed description
MC MD
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Provision of subject informed consent 2. Female or male aged = 18 years 3. Patients eligible for treatment of dyslipidemia with statins, according to the current guidelines NCEP ATPIII about Dyslipidemias and Atherosclerosis Prevention. 4. Receiving lipid-lowering drug treatment for at least 15 days.
Key inclusion criteria (2 listed)
- Provision of subject informed consent, Female or male aged = 18 years
- Patients eligible for treatment of dyslipidemia with statins, according to the current guidelines NCEP ATPIII about Dyslipidemias and Atherosclerosis Prevention Receiving lipid-lowering drug treatment for at least 15 days.
Key exclusion criteria (3 listed)
- Involvement in the planning and conduct of the study (applies to either 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 (#) of subjects achieving the LDL-C goals according to updated 2004 NCEP ATP III guidelines.
Time frame: 1 year
The percent (%) of subjects achieving the LDL-C goals according to updated 2004 NCEP ATP III guidelines.
Time frame: 1 year
6 secondary outcomes
The number of subjects achieving the LDL-C goals according to the updated 2004 NCEP ATP III guidelines for several subject subsets
Time frame: 1 year
The number of the secondary event rate of cerebrovascular patients on lipid-lowering pharmacological treatment (statin or combination) who reaching and non-reaching the LDL-C goals according to the updated 2004 NCEP ATP III guidelines for 1
Time frame: 1 year
The number of the secondary event rate cardiovascular patients on lipid-lowering pharmacological treatment (statin or combination) who reaching and non-reaching the LDL-C goals according to the updated 2004 NCEP ATP III guidelines for 1 year
Time frame: 1 year
The percentage of subjects achieving the LDL-C goals according to the updated 2004 NCEP ATP III guidelines for several subject subsets
Time frame: 1 year
The percent of the secondary event rate of cerebrovascular patients on lipid-lowering pharmacological treatment (statin or combination) who reaching and non-reaching the LDL-C goals according to the updated 2004 NCEP ATP III guidelines for 1
Time frame: 1 year
The percent of the secondary event rate cardiovascular patients on lipid-lowering pharmacological treatment (statin or combination) who reaching and non-reaching the LDL-C goals according to the updated 2004 NCEP ATP III guidelines for 1 year
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2011.
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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.
Apichard Sukonthasarn, Prof.M.D. principal investigator
Maharaj Nakorn Chiangmai Hospital Cardiovascular division, Department of Internal Medicine, Faculty of Medicine, Chiangmai University
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemia, 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 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: withdrawn, as of the sponsor's last update on 12 Apr 2011. 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 was withdrawn before enrolling participants, so there are no results.
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 (#) of subjects achieving the LDL-C goals according to updated 2004 NCEP ATP III guidelines. (time frame: 1 year). 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 12 Apr 2011.