Trial record 1 of 1 for:
NIS-CHR-CRE-2010/1
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:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01257971
First received: December 6, 2010
Last updated: March 19, 2012
Last verified: March 2012
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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
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 | |
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| Gospic, Croatia | |
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| 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 May 16, 2013