To Evaluate the Renal Protective Effects and Safety of 'Fimasartan and Atorvastatin' or 'Fimasartan, Atorvastatin and Ezetimibe'.
28. juni 2026 opdateret af: Boryung Pharmaceutical Co., Ltd
A Multicenter, Prospective Observational Study to Evaluate the Renal Protective Effects and Safety of 'Fimasartan and Atorvastatin' or 'Fimasartan, Atorvastatin and Ezetimibe' in Patients With Essential Hypertension and Primary Hypercholesterolemia.
This prospective study aims to observe changes in renal function and related parameters in patients with essential hypertension and primary hypercholesterolemia receiving either the combination of fimasartan and atorvastatin or the combination of fimasartan, atorvastatin, and ezetimibe.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Anslået)
12700
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: MyungSook Hong
- Telefonnummer: 8227088238
- E-mail: mshong@boryung.co.kr
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients diagnosed with essential hypertension and primary hypercholesterolemia
Beskrivelse
Inclusion Criteria:
- Those who are briefed about the clinical trial objectives and methods, and express their consent to participate in the trial by signing a written consent on the use of their personal information.
- Patients diagnosed with essential hypertension and primary hypercholesterolemia.
- Patients scheduled to receive either fimasartan plus atorvastatin or fimasartan plus atorvastatin plus ezetimibe.
Exclusion Criteria:
- Patients who received concomitant administration of fimasartan and atorvastatin within 4 weeks prior to baseline.
- Patients with any contraindication to fimasartan, atorvastatin, or ezetimibe as specified in the approved product labeling.
- Patients who have received investigational or study drugs from another clinical trial or research study within 12 weeks prior to baseline. However, participation in non-interventional observational studies is permitted.
- Patients considered unsuitable for study participation at the discretion of the principal investigator or sub-investigator.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The proportion of patients with positive urine dipstick albuminuria
Tidsramme: Week 12
|
Week 12
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in UACR from baseline to Weeks 12 and 24
Tidsramme: Week 12, Week 24
|
UACR is defined as the urine albumin-to-creatinine ratio
|
Week 12, Week 24
|
|
Proportion of participants achieving a ≥30% reduction in UACR from baseline at Weeks 12 and 24
Tidsramme: Week 12, Week 24
|
UACR is defined as the urine albumin-to-creatinine ratio
|
Week 12, Week 24
|
|
Change in UPCR from baseline to Weeks 12 and 24
Tidsramme: Week 12, Week 24
|
UPCR is defined as the urine protein-to-creatinine ratio
|
Week 12, Week 24
|
|
Proportion of participants achieving a ≥30% reduction in UPCR from baseline at Weeks 12 and 24
Tidsramme: Week 12, Week 24
|
UPCR is defined as the urine protein-to-creatinine ratio
|
Week 12, Week 24
|
|
Change in eGFR from baseline to Weeks 12 and 24
Tidsramme: Week 12, Week 24
|
eGFR is defined as the estimated glomerular filtration rate
|
Week 12, Week 24
|
|
Proportion of participants with a ≥50% decline in eGFR from baseline at Weeks 12 and 24
Tidsramme: Week 12, Week 24
|
eGFR is defined as the estimated glomerular filtration rate
|
Week 12, Week 24
|
|
Change in blood pressure from baseline at Weeks 12 and 24
Tidsramme: Week 12, Week 24
|
Week 12, Week 24
|
|
|
Proportion of participants achieving the target blood pressure at Weeks 12 and 24
Tidsramme: Week 12, Week 24
|
Week 12, Week 24
|
|
|
Change in lipid profile (TC, HDL-C, TG, and LDL-C) from baseline at Weeks 12 and 24
Tidsramme: Week 12, Week 24
|
Lipid proflie was defined that Total cholesterol (TC); High-density lipoprotein cholesterol (HDL-C);Triglycerides (TG); Low-density lipoprotein cholesterol (LDL-C)
|
Week 12, Week 24
|
|
Proportion of participants achieving the target LDL-C level at Weeks 12 and 24
Tidsramme: Week 12, Week 24
|
Week 12, Week 24
|
|
|
Proportion of participants achieving both the target blood pressure and target LDL-C level at Weeks 12 and 24
Tidsramme: Week 12, Week 24
|
Week 12, Week 24
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
15. august 2029
Studieafslutning (Anslået)
15. august 2029
Datoer for studieregistrering
Først indsendt
28. juni 2026
Først indsendt, der opfyldte QC-kriterier
28. juni 2026
Først opslået (Faktiske)
6. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BR-FAEC-OS-401
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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