Observational Study to Evaluate Achieving LDL-cholesterol Target Level to Treat With Rovazet Tab. With Dyslipidemia Patients
A Multi-center, Prospective, Observational Study to Evaluate Achieving LDL-cholesterol Target Level to Treat With Rovazet Tab. With Dyslipidemia Patients
This study will be conducted under routine clinical practice. Rovazet tablets will be administered in accordance with the approved dosage and administration as part of standard clinical care for dyslipidemia. Data will be collected at up to three time points from study enrollment through Week 48: baseline, Week 24, and Week 48.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
This study is designed as a multicenter, prospective study to evaluate the effectiveness and safety of Rovazet tablets in patients diagnosed with dyslipidemia for whom treatment with Rovazet has been determined under routine clinical practice.
During routine clinical visits, the investigator will determine whether treatment with Rovazet tablets is appropriate for patients diagnosed with dyslipidemia. In the course of routine clinical care, the investigator will determine the dose and prescribe Rovazet tablets in accordance with the product labeling. The medication to be administered to the participant must be determined before the participant provides consent to participate in the study and without any intervention related to the study.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Yongan Jeong
- Telefonnummer: +82-31-5176-4673
- E-mail: yongan.jeong@inno-n.com
Undersøgelse Kontakt Backup
- Navn: Nayoung Lee
- Telefonnummer: +82-31-5176-4675
- E-mail: nayoung.lee1@inno-n.com
Studiesteder
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-
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Seoul, Sydkorea
- Rekruttering
- HK inno.N Corporation
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Kontakt:
- Ahrong Kim
- Telefonnummer: +82-31-5176-4666
- E-mail: ahrong.kim@inno-n.com
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Kontakt:
- Nayoung Lee
- Telefonnummer: +82-31-5176-4675
- E-mail: nayoung.lee1@inno-n.com
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
6,713
Beskrivelse
Inclusion Criteria:
- Adults aged 19 years or older who have been diagnosed with dyslipidemia.
- Patients for whom treatment with Rovazet tablets has been determined based on the investigator's medical judgment.
- Patients with LDL-C and HDL-C test results obtained within 3 months before the date of enrollment.
- Individuals who have voluntarily provided written informed consent to participate in this study.
Exclusion Criteria:
- Patients for whom Rovazet tablets are contraindicated according to the contraindications listed in the approved product labeling.
- Patients whom the investigator considers unsuitable for participation in this study for any other reason.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: OTHER
- Tidsperspektiver: PROSPECTIVE
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The proportion of study participants who achieve the LDL-C treatment target at Week 24, according to the dyslipidemia treatment guidelines
Tidsramme: Day 1 to week 24
|
LDL-C treatment targets in the fifth edition of the Korean Society of Lipid and Atherosclerosis clinical practice guidelines |
Day 1 to week 24
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The proportion of study participants who achieve the LDL-C treatment target at Week 48, according to the dyslipidemia treatment guidelines.
Tidsramme: Day 1 to week 48
|
Day 1 to week 48
|
|
|
The percentage change from baseline in lipid profile parameters (TC, TG, HDL-C, and LDL-C) at Week 24.
Tidsramme: Day 1 to week 24
|
Percentage change (%) = [(Lipid profile parameter at Week 24 - Lipid profile parameter at baseline) / Lipid profile parameter at baseline] × 100 |
Day 1 to week 24
|
|
The percentage change from baseline in lipid profile parameters (TC, TG, HDL-C, and LDL-C) at Week 48.
Tidsramme: Day 1 to week 48
|
Percentage change (%) = [(Lipid profile parameter at Week 48 - Lipid profile parameter at baseline) / Lipid profile parameter at baseline] × 100 |
Day 1 to week 48
|
|
Medication adherence
Tidsramme: Day 1 to week 48
|
Assessed using the medication possession ratio (MPR) |
Day 1 to week 48
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IN_RVZ_N01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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