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
  Purpose

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.


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 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) Reductase Inhibitors in Croatia

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1868
Study Start Date: January 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with hypercholesterolaemia

  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 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.
  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: NCT01257971

Locations
Croatia
Research Site
Biograd na moru, Croatia
Research Site
Bjelovar, Croatia
Research Site
Cakovec, Croatia
Research Site
Crikvenica, Croatia
Research Site
Dubrovnik, Croatia
Research Site
Gospic, Croatia
Research Site
Karlovac, Croatia
Research Site
Koprivnica, Croatia
Research Site
Krapina, Croatia
Research Site
Krapinske toplice, Croatia
Research Site
Opatija, Croatia
Research Site
Osijek, Croatia
Research Site
Porec, Croatia
Research Site
Pula, Croatia
Research Site
Rijeka, Croatia
Research Site
Sisak, Croatia
Research Site
Slavonski brod, Croatia
Research Site
Split, Croatia
Research Site
Stubicke toplice, Croatia
Research Site
Umag, Croatia
Research Site
Vinkovci, Croatia
Research Site
Virovitica, Croatia
Research Site
Virovitica- Slatina, Croatia
Research Site
Vukovar, Croatia
Research Site
Zadar, Croatia
Research Site
Zageb, Croatia
Research Site
Zagreb, Croatia
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Svjetlana Serdar AstraZeneca
Study Director: Karin Otter AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01257971     History of Changes
Other Study ID Numbers: NIS-CHR-CRE-2010/1
Study First Received: December 6, 2010
Last Updated: March 19, 2012
Health Authority: Croatia: Ministry of Health and Social Care

Keywords provided by AstraZeneca:
Cholesterol
HMG-CoA reductase inhibitor
cardiovascular risk
LDLl

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

ClinicalTrials.gov processed this record on September 29, 2014