Non-interventional Study (NIS) to Assess Reaching of Cholesterol Target Values in Patients Treated With HMG-CoA Reductase Inhibitors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01257971
First received: December 6, 2010
Last updated: March 19, 2012
Last verified: March 2012

December 6, 2010
March 19, 2012
January 2011
October 2011   (final data collection date for primary outcome measure)
  • Number 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 ]
  • 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 NCT01257971 on ClinicalTrials.gov Archive Site
  • Number 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 ]
  • Number 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 ]
  • Number 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 ]
  • 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 ]
  • 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 ]
  • 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
 
Non-interventional Study (NIS) to Assess Reaching of Cholesterol Target Values in Patients Treated With HMG-CoA Reductase Inhibitors
Non-interventional Study to Assess Reaching of Cholesterol Target Values in Patients Treated With 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) Reductase Inhibitors in Croatia

This is a multi-centre non-interventional study of patients who are treated with any HMGCoA reductase inhibitor available in Croatia (rosuvastatin, simvastatin, atorvastatin and fluvastatin) for at least 6 months. All HMG-CoA reductase inhibitors must be prescribed in accordance with SmPCs approved in Croatia. Data collection for each patient will take place at a single visit. The investigator will complete a Case Report Form with the patient's demographics, the presence of the factors for high cardiovascular risk, current treatment, cholesterol values as well as with further treatment decision.

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

Patients treated by specialist

Hypercholesterolaemia
Not Provided
1
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
1868
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients who have been treated with one HMG-CoA reductase inhibitor 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 Croatia.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Croatia
 
NCT01257971
NIS-CHR-CRE-2010/1
No
AstraZeneca
AstraZeneca
Not Provided
Study Chair: Svjetlana Serdar AstraZeneca
Study Director: Karin Otter AstraZeneca
AstraZeneca
March 2012

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