NCT01206231

Brief Summary

This study is aimed to collect the following Serbia-specific epidemiology data on hypercholesterolemia: patents characteristics, patients' management/treatment and physicians' standard practice. In addition, the aim is to determine the proportion of patients on lipid-lowering pharmacological treatment who have reached the LDL-C and HDL-C treatment goals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Shorter than P25 for all trials

Geographic Reach
1 country

10 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

10 months

First QC Date

September 20, 2010

Last Update Submit

November 7, 2011

Conditions

Keywords

Standard daily practice in managing patients with hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III / updated 2004 NCEP ATP III guidelines

    24 weeks

Secondary Outcomes (3)

  • Proportion of patients on lipid-lowering pharmacological treatment reaching the non HDL-C goals according to the NCEP ATP III / updated 2004 NCEP ATP III guidelines;

    24 weeks

  • Physicians' standard practice in managing patients with hypercholesterolemia (by using physicians' questionnaire);

    24 weeks

  • Local epidemiological date on patients with hypercholesterolemia (Demographic Data; Hypercholesterolemia management data: treatment, treatment changes)

    24 weeks

Study Arms (1)

1

Patients with hypercholesterolemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Speciality care clinics

You may qualify if:

  • Patients with hypercholesterolemia currently receiving a lipid lowering agent

You may not qualify if:

  • Pregnancy and lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research Site

Belgrade, Serbia

Location

Research Site

Čačak, Serbia

Location

Research Site

Kamenitz, Serbia

Location

Research Site

Kragujevac, Serbia

Location

Research Site

Niš, Serbia

Location

Research Site

Niška Banja, Serbia

Location

Research Site

Pančevo, Serbia

Location

Research Site

Požarevac, Serbia

Location

Research Site

Sombor, Serbia

Location

Research Site

Užice, Serbia

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Prof.Dr Miodrag Ostojic

    Division of Cardiology-Clinical Centre of Serbia-Belgrade

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2010

First Posted

September 21, 2010

Study Start

December 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations