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

February 29, 2012 updated by: AstraZeneca
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • 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
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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..

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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..

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 visit - 1-3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
1 visit - 1-3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Prof. Boytsov, RKNPK
  • Principal Investigator: Acad Oganov, Center of preventive medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

October 14, 2010

First Submitted That Met QC Criteria

October 14, 2010

First Posted (ESTIMATE)

October 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 1, 2012

Last Update Submitted That Met QC Criteria

February 29, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CRU-DUM-2010/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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