Centralized Pan-Russian Survey on the Undertreatment of Hypercholesterolemia

Dyslipidaemia Clinical Trial

— CEPHEUS  

Official title:

Centralized Pan-Russian Survey on the Undertreatment of Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221584
• Other study ID #: NIS-CRU-DUM-2010/1
• Status: Completed
• Phase: N/A
• First received: October 14, 2010
• Last updated: February 29, 2012
• Start date: October 2010
• Est. completion date: March 2011

Study information

• Verified date: February 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the All-Russian Scientific Cardiology Society guidelines/ the 4th Joint European Task Force guidelines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• 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

• Dyslipidaemia
• Dyslipidemias
• Hypercholesterolemia

Locations

Country	Name	City	State
Russian Federation	Research Site	Krasnodar
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Nizhniy Novgorod
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Samara
Russian Federation	Research Site	Voronezh
Russian Federation	Research Site	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the All-Russian Scientific Cardiology Society guidelines/the Fourth Joint European Task Force guidelines		1 visit - 1-3 days	No
Secondary	Establish the proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the Russian guidelines in the following sub-populations: Primary/secondary prevention patients, Patients with metabolic syndrome		1 visit - 1-3 days	No
Secondary	Establish the proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the FJETF/ NCEP ATP III guidelines, in all population and in Primary/secondary prevention patients, Patients with metabolic syndrome		1 visit - 1-3 days	No
Secondary	Establish the proportion of patients on lipid-lowering treatment reaching the non HDL-C goals according to the NCEP ATP III / updated 2004 NCEP ATP III guidelines in the sub-population patients with fasting triglycerides >200 mg/dL (2.26mmol/L)		1 visit - 1-3 days	No