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Dyslipidemia Treatment in Thailand and Cardiovascular Outcomes (DEMAND)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01265836
First received: December 14, 2010
Last updated: April 11, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition
Dyslipidemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dyslipidemia Treatment in Thailand and Cardiovascular Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Statins
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The number (#) of subjects achieving the LDL-C goals according to updated 2004 NCEP ATP III guidelines. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The percent (%) of subjects achieving the LDL-C goals according to updated 2004 NCEP ATP III guidelines. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1064
Study Start Date: March 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Detailed Description:

MC MD

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265836

Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Apichard Sukonthasarn, Prof.M.D. Maharaj Nakorn Chiangmai Hospital Cardiovascular division, Department of Internal Medicine, Faculty of Medicine, Chiangmai University
  More Information

No publications provided

Responsible Party: Marketing Company Medical Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01265836     History of Changes
Other Study ID Numbers: NIS-CTH-DUM-2010/1
Study First Received: December 14, 2010
Last Updated: April 11, 2011
Health Authority: Thailand: Ministry of Public Health

Keywords provided by AstraZeneca:
Dyslipidemia Treatment and Cardiovascular Outcomes

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013