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Centralized Pan-South African Survey on the Undertreatment of Hypercholesterolaemia (CEPHEUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01027624
Recruitment Status : Completed
First Posted : December 8, 2009
Last Update Posted : April 15, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
This is a multi-centre survey of patients who are currently on lipid lowering pharmacological treatment in South Africa.

Condition or disease
Undertreatment of Hypercholesterolaemia

Study Design

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Centralized Pan-South African Survey on the Undertreatment of Hypercholesterolaemia.
Study Start Date : November 2009
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Hyperchlesterolaemia
Participants undertreated with hypercholesterolaemia


Outcome Measures

Primary Outcome Measures :
  1. Proportion of patients on lipid-lowering pharmacological treatment reaching LDL-C goals according to NCEP ATP III/Updated 2004 NCEP ATP III

Secondary Outcome Measures :
  1. Proportion of patients on lipid-lowering pharmacological treatment reaching LDL-C goals according to NCEP ATP III/Updated 2004 NCEP ATP III
  2. Proportion of patients on lipid-lowering pharmacological treatment reaching LDL-C goals according to the Fourth Joint European Task Force Guidelines/South African Guidelines in primary/secondary prevention patients, patients with metabolic syndrome
  3. Proportion of patients on lipid-lowering pharmacological treatment reaching the non HDL-C goals according to NCEP ATP III/Updated 2004 NCEP ATP III Guidelines

Biospecimen Retention:   Samples Without DNA
Serum

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Multi-centre survey of patients who are currently on lipid-lowering pharmacological treatment in South Africa.
Criteria

Inclusion Criteria:

  • Subject must be 18 years of age or older of either gender or race.
  • Subject must provide informed consent and comply with the survey procedures.
  • Subject is on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.

Exclusion Criteria:

  • Subjects who are unwilling or unable to provide informed consent.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01027624


Locations
South Africa
Research Site
Johannesburg, South Africa
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Prof F Raal National Co-ordinator
More Information

Responsible Party: MC MD, AstraZeneca Pharmaceuticals Pty Ltd
ClinicalTrials.gov Identifier: NCT01027624     History of Changes
Other Study ID Numbers: NIS-CZA-DUM-2009/1
First Posted: December 8, 2009    Key Record Dates
Last Update Posted: April 15, 2011
Last Verified: April 2011

Keywords provided by AstraZeneca:
Pan South African Survey on the Undertreatment of Hypercholesterolaemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases