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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01221584
First Posted: October 15, 2010
Last Update Posted: March 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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 ]

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 ]
  • 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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01221584     History of Changes
Other Study ID Numbers: NIS-CRU-DUM-2010/1
First Submitted: October 14, 2010
First Posted: October 15, 2010
Last Update Posted: March 1, 2012
Last Verified: February 2012

Keywords provided by AstraZeneca:
Dyslipidaemia
LDL-C goals
guidelines

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