NCT01483950

Brief Summary

This study is non-interventional study of patients who are treated with any HMGCoA reductase inhibitors (rosuvastatin, simvastatin,atorvastatin and fluvastatin) available in Bosnia and Herzegovina for at least 6 months. Data collection for each patient will take place at a single visit. The investigators will complete Case Report Form (CRF) with patient's demographic, the presence of the factors for high cardiovascular risk, current treatment, cholesterol value as well as with further treatment decision.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 for all trials

Geographic Reach
1 country

14 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

First Submitted

Initial submission to the registry

November 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

9 months

First QC Date

November 30, 2011

Last Update Submit

February 4, 2013

Conditions

Hypercholesterolaemia

Keywords

DyslipidemiaStatinsTotal CholesterolLow density lipoprotein (LDL) cholesterolHigh density lipoprotein (HDL) cholesterol

Outcome Measures

Primary Outcomes (1)

  • The number and percentage of patients reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline.

    During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated

Secondary Outcomes (3)

  • The number and percentage of patients reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline.

    During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated

  • The number and percentage of patients with high cardiovascular risk reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline.

    During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated

  • The number and percentage of patients with high cardiovascular risk reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline.

    During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated

Study Arms (1)

Patients with hypercholesterolaemia

Eligibility Criteria

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

Patients treated by specialist

You may qualify if:

  • Patients, treated with one HMG-CoA reductase inhibitors for at least 6 months without changing the dose for the last 4 weeks at least
  • All patients must sign informed consent form

You may not qualify if:

  • Patients who have not signed the Informed Consent Form
  • Patients with contraindication for the treatment with HMG-CoA reductase inhibitors as per SmPC approved in Bosnia and Herzegovina

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Research Site

Banja Luka, Bosnia and Herzegovina

Location

Research Site

Bijeljina, Bosnia and Herzegovina

Location

Research Site

Doboj, Bosnia and Herzegovina

Location

Reserach Site

Gradiška, Bosnia and Herzegovina

Location

Research Site

Kakanj, Bosnia and Herzegovina

Location

Research Site

Maglaj, Bosnia and Herzegovina

Location

Research Site

Prijedor, Bosnia and Herzegovina

Location

Research Site

Sarajevo, Bosnia and Herzegovina

Location

Research Site

Tešanj, Bosnia and Herzegovina

Location

Research Site

Trebinje, Bosnia and Herzegovina

Location

Research Site

Visoko, Bosnia and Herzegovina

Location

Research Site

Zavidovići, Bosnia and Herzegovina

Location

Research Site

Zenica, Bosnia and Herzegovina

Location

Research Site

Zvornik, Bosnia and Herzegovina

Location

MeSH Terms

Conditions

HypercholesterolemiaDyslipidemias

Condition Hierarchy (Ancestors)

HyperlipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Vesna Loza, DOC. DR. SCI. MED

    Klinika za bolesti srca i reumatizma Sarajevo , Bosnia and Herzegovina

    PRINCIPAL INVESTIGATOR

  • Meta Jeras, MR PH

    West Balkan MD

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 30, 2011

First Posted

December 2, 2011

Study Start

April 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations

BO(14)