- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01265836
Dyslipidemia Treatment in Thailand and Cardiovascular Outcomes (DEMAND)
April 11, 2011 updated by: AstraZeneca
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.
Study Overview
Status
Withdrawn
Conditions
Detailed Description
MC MD
Study Type
Observational
Enrollment (Anticipated)
1064
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- 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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number (#) of subjects achieving the LDL-C goals according to updated 2004 NCEP ATP III guidelines.
Time Frame: 1 year
|
1 year
|
The percent (%) of subjects achieving the LDL-C goals according to updated 2004 NCEP ATP III guidelines.
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
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
|
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
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Apichard Sukonthasarn, Prof.M.D., Maharaj Nakorn Chiangmai Hospital Cardiovascular division, Department of Internal Medicine, Faculty of Medicine, Chiangmai University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Anticipated)
March 1, 2013
Study Completion (Anticipated)
March 1, 2013
Study Registration Dates
First Submitted
December 14, 2010
First Submitted That Met QC Criteria
December 22, 2010
First Posted (Estimate)
December 23, 2010
Study Record Updates
Last Update Posted (Estimate)
April 12, 2011
Last Update Submitted That Met QC Criteria
April 11, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-CTH-DUM-2010/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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