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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Yongan Jeong
- Telefonnummer: +82-31-5176-4673
- E-post: yongan.jeong@inno-n.com
Studera Kontakt Backup
- Namn: Nayoung Lee
- Telefonnummer: +82-31-5176-4675
- E-post: nayoung.lee1@inno-n.com
Studieorter
-
-
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Seoul, Sydkorea
- Rekrytering
- HK inno.N Corporation
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Kontakt:
- Ahrong Kim
- Telefonnummer: +82-31-5176-4666
- E-post: ahrong.kim@inno-n.com
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Kontakt:
- Nayoung Lee
- Telefonnummer: +82-31-5176-4675
- E-post: nayoung.lee1@inno-n.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
6,713
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: OTHER
- Tidsperspektiv: PROSPECTIVE
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The proportion of study participants who achieve the LDL-C treatment target at Week 24, according to the dyslipidemia treatment guidelines
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The proportion of study participants who achieve the LDL-C treatment target at Week 48, according to the dyslipidemia treatment guidelines.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
Tidsram: Day 1 to week 48
|
Assessed using the medication possession ratio (MPR) |
Day 1 to week 48
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IN_RVZ_N01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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