Evaluation of Patients Treated With HMG-CoA Reductase Inhibitors to Reach Cholesterol Target Values
4. februar 2013 opdateret af: AstraZeneca
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Non-interventional study to assess reaching of cholesterol target values in patients treated with HMG-CoA reductase inhibitors in Bosnia and Herzegovina
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
800
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Banja Luka, Bosnien-Hercegovina
- Research Site
-
Bijeljina, Bosnien-Hercegovina
- Research Site
-
Doboj, Bosnien-Hercegovina
- Research Site
-
Gradiška, Bosnien-Hercegovina
- Reserach Site
-
Kakanj, Bosnien-Hercegovina
- Research Site
-
Maglaj, Bosnien-Hercegovina
- Research Site
-
Prijedor, Bosnien-Hercegovina
- Research Site
-
Sarajevo, Bosnien-Hercegovina
- Research Site
-
Tešanj, Bosnien-Hercegovina
- Research Site
-
Trebinje, Bosnien-Hercegovina
- Research Site
-
Visoko, Bosnien-Hercegovina
- Research Site
-
Zavidovići, Bosnien-Hercegovina
- Research Site
-
Zenica, Bosnien-Hercegovina
- Research Site
-
Zvornik, Bosnien-Hercegovina
- Research Site
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients treated by specialist
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Patients with hypercholesterolaemia
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The number and percentage of patients reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline.
Tidsramme: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
|
During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The number and percentage of patients reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline.
Tidsramme: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
|
During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
|
|
The number and percentage of patients with high cardiovascular risk reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline.
Tidsramme: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
|
During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
|
|
The number and percentage of patients with high cardiovascular risk reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline.
Tidsramme: During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
|
During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Vesna Loza, DOC. DR. SCI. MED, Klinika za bolesti srca i reumatizma Sarajevo , Bosnia and Herzegovina
- Studieleder: Meta Jeras, MR PH, West Balkan MD
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2012
Primær færdiggørelse (Faktiske)
1. januar 2013
Studieafslutning (Faktiske)
1. januar 2013
Datoer for studieregistrering
Først indsendt
30. november 2011
Først indsendt, der opfyldte QC-kriterier
1. december 2011
Først opslået (Skøn)
2. december 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. februar 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. februar 2013
Sidst verificeret
1. februar 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NIS-CBA-CRE-2011/1
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .