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
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: 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:
Dyslipidemias
Hypercholesterolemia
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014