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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01027624
First received: December 4, 2009
Last updated: April 14, 2011
Last verified: April 2011
  Purpose

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


Condition
Undertreatment of Hypercholesterolaemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Centralized Pan-South African Survey on the Undertreatment of Hypercholesterolaemia.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Proportion of patients on lipid-lowering pharmacological treatment reaching LDL-C goals according to NCEP ATP III/Updated 2004 NCEP ATP III [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients on lipid-lowering pharmacological treatment reaching LDL-C goals according to NCEP ATP III/Updated 2004 NCEP ATP III [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum


Estimated Enrollment: 3000
Study Start Date: November 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hyperchlesterolaemia
Participants undertreated with hypercholesterolaemia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027624

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

No publications provided

Responsible Party: MC MD, AstraZeneca Pharmaceuticals Pty Ltd
ClinicalTrials.gov Identifier: NCT01027624     History of Changes
Other Study ID Numbers: NIS-CZA-DUM-2009/1
Study First Received: December 4, 2009
Last Updated: April 14, 2011
Health Authority: South Africa: Department of Health
South Africa: Human Research Ethics Committee

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

ClinicalTrials.gov processed this record on August 21, 2014