Evaluation of Patients Treated With HMG-CoA Reductase Inhibitors to Reach Cholesterol Target Values

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01483950

First received: November 30, 2011

Last updated: February 4, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 30, 2011

Last Updated Date

February 4, 2013

Start Date ^ICMJE

April 2012

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The number and percentage of patients reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline. [ Time Frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01483950 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The number and percentage of patients reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline. [ Time Frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated ] [ Designated as safety issue: No ]
The number and percentage of patients with high cardiovascular risk reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline. [ Time Frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated ] [ Designated as safety issue: No ]
The number and percentage of patients with high cardiovascular risk reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline. [ Time Frame: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluation of Patients Treated With HMG-CoA Reductase Inhibitors to Reach Cholesterol Target Values

Official Title ^ICMJE

Non-interventional Study to Assess Reaching of Cholesterol Target Values in Patients Treated With HMG-CoA Reductase Inhibitors in Bosnia and Herzegovina

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.

Detailed Description

Non-interventional study to assess reaching of cholesterol target values in patients treated with HMG-CoA reductase inhibitors in Bosnia and Herzegovina

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients treated by specialist

Condition ^ICMJE

Hypercholesterolaemia

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Patients with hypercholesterolaemia

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

800

Completion Date

January 2013

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Bosnia and Herzegovina

Administrative Information

NCT Number ^ICMJE

NCT01483950

Other Study ID Numbers ^ICMJE

NIS-CBA-CRE-2011/1

Has Data Monitoring Committee

Yes

Responsible Party

AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Vesna Loza, DOC. DR. SCI. MED	Klinika za bolesti srca i reumatizma Sarajevo , Bosnia and Herzegovina
Study Director:	Meta Jeras, MR PH	West Balkan MD

Information Provided By

AstraZeneca

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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