NCT01221584

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Shorter than P25 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 1, 2012

Status Verified

February 1, 2012

Enrollment Period

5 months

First QC Date

October 14, 2010

Last Update Submit

February 29, 2012

Conditions

Keywords

DyslipidaemiaLDL-C goalsguidelines

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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..

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects who are unwilling or unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Research Site

Krasnodar, Russia

Location

Research Site

Moscow, Russia

Location

Research Site

Nizhny Novgorod, Russia

Location

Research Site

Novosibirsk, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Samara, Russia

Location

Research Site

Voronezh, Russia

Location

Research Site

Yaroslavl, Russia

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Alexey Stepanov, Prof

    AstraZeneca

    STUDY DIRECTOR
  • Prof. Boytsov

    RKNPK

    PRINCIPAL INVESTIGATOR
  • Acad Oganov

    Center of preventive medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2010

First Posted

October 15, 2010

Study Start

October 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 1, 2012

Record last verified: 2012-02

Locations