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
  Purpose

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.


Condition
Hypercholesterolaemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Non-interventional Study to Assess Reaching of Cholesterol Target Values in Patients Treated With HMG-CoA Reductase Inhibitors in Bosnia and Herzegovina

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 800
Study Start Date: April 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with hypercholesterolaemia

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients treated by specialist

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483950

Locations
Bosnia and Herzegovina
Research Site
Banja Luka, Bosnia and Herzegovina
Research Site
Bijeljina, Bosnia and Herzegovina
Research Site
Doboj, Bosnia and Herzegovina
Reserach Site
Gradiška, Bosnia and Herzegovina
Research Site
Kakanj, Bosnia and Herzegovina
Research Site
Maglaj, Bosnia and Herzegovina
Research Site
Prijedor, Bosnia and Herzegovina
Research Site
Sarajevo, Bosnia and Herzegovina
Research Site
Tešanj, Bosnia and Herzegovina
Research Site
Trebinje, Bosnia and Herzegovina
Research Site
Visoko, Bosnia and Herzegovina
Research Site
Zavidovići, Bosnia and Herzegovina
Research Site
Zenica, Bosnia and Herzegovina
Research Site
Zvornik, Bosnia and Herzegovina
Sponsors and Collaborators
AstraZeneca
Investigators
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01483950     History of Changes
Other Study ID Numbers: NIS-CBA-CRE-2011/1
Study First Received: November 30, 2011
Last Updated: February 4, 2013
Health Authority: Bosnia and Herzegovina: Agency for Medicinal Rroduct and Medicinal Devices of Bosnia and Herzegovina (Clinical Trial Board)

Keywords provided by AstraZeneca:
Dyslipidemia
Statins
Total Cholesterol
Low density lipoprotein (LDL) cholesterol
High density lipoprotein (HDL) cholesterol

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014