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
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 April 16, 2014