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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

November 30, 2011
February 4, 2013
April 2012
January 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01483950 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of Patients Treated With HMG-CoA Reductase Inhibitors to Reach Cholesterol Target Values
Non-interventional Study to Assess Reaching of Cholesterol Target Values in Patients Treated With HMG-CoA Reductase Inhibitors in Bosnia and Herzegovina

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.

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

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Patients treated by specialist

Hypercholesterolaemia
Not Provided
Patients with hypercholesterolaemia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Bosnia and Herzegovina
 
NCT01483950
NIS-CBA-CRE-2011/1
Yes
AstraZeneca
AstraZeneca
Not Provided
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
AstraZeneca
February 2013

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