Centralized Pan-Russian Survey on the Undertreatment of Hypercholesterolemia (CEPHEUS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01221584
First received: October 14, 2010
Last updated: February 29, 2012
Last verified: February 2012
  Purpose

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.


Condition
Dyslipidaemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Centralized Pan-Russian Survey on the Undertreatment of Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 [ Time Frame: 1 visit - 1-3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 1 visit - 1-3 days ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 1 visit - 1-3 days ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 1 visit - 1-3 days ] [ Designated as safety issue: No ]

Enrollment: 1000
Study Start Date: October 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Subject 18 years of age or older on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks..

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subject on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks..

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: NCT01221584

Locations
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, Russian Federation
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Alexey Stepanov, Prof AstraZeneca
Principal Investigator: Prof. Boytsov RKNPK
Principal Investigator: Acad Oganov Center of preventive medicine
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01221584     History of Changes
Other Study ID Numbers: NIS-CRU-DUM-2010/1
Study First Received: October 14, 2010
Last Updated: February 29, 2012
Health Authority: Russia: Ethics Committee

Keywords provided by AstraZeneca:
Dyslipidaemia
LDL-C goals
guidelines

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

ClinicalTrials.gov processed this record on April 16, 2014