Centralized Pan-South African Survey on the Undertreatment of Hypercholesterolaemia

Undertreatment of Hypercholesterolaemia Clinical Trial

— CEPHEUS  

Official title:

Centralized Pan-South African Survey on the Undertreatment of Hypercholesterolaemia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027624
• Other study ID #: NIS-CZA-DUM-2009/1
• Status: Completed
• Phase: N/A
• First received: December 4, 2009
• Last updated: April 14, 2011
• Start date: November 2009
• Est. completion date: April 2010

Study information

• Verified date: April 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Department of HealthSouth Africa: Human Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypercholesterolemia
• Undertreatment of Hypercholesterolaemia

Locations

Country	Name	City	State
South Africa	Research Site	Johannesburg

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients on lipid-lowering pharmacological treatment reaching LDL-C goals according to NCEP ATP III/Updated 2004 NCEP ATP III			No
Secondary	Proportion of patients on lipid-lowering pharmacological treatment reaching LDL-C goals according to NCEP ATP III/Updated 2004 NCEP ATP III			No
Secondary	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			No
Secondary	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			No