Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

A Trial of HRS-1780 in Participants With Uncontrolled Hypertension or Resistant Hypertension.

27 augustus 2026 bijgewerkt door: Shandong Suncadia Medicine Co., Ltd.

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of HRS-1780 in Participants With Uncontrolled Hypertension or Resistant Hypertension.

The study is being conducted to evaluate the efficacy and safety of HRS-1780 in participants with uncontrolled hypertension or resistant hypertension. To explore the optimal use of HRS-1780 in participants with uncontrolled hypertension or resistant hypertension。

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Geschat)

914

Fase

  • Fase 2
  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400042
        • Army Characteristic Medical Center of the People's Liberation Army
        • Hoofdonderzoeker:
          • Chunyu Zeng
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200080
        • Zhongshan hospital, Fudan university
        • Hoofdonderzoeker:
          • Xiaoqiang Ding

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  1. Male or female, aged ≥ 18 and < 80 years ;
  2. Mean trough seated SBP ≥ 140 mmHg and < 170 mmHg at both screening and randomization visits.
  3. Meet one of the following two criteria:

    1. Meet the criteria for uncontrolled hypertension;
    2. Meet the criteria for resistant hypertension;
  4. Serum potassium ≥ 3.5 mmol/L and ≤ 5.0 mmol/L ;
  5. Voluntarily sign the ICF prior to the study;
  6. Have no plan for fertility from the time of signing the ICF until 4 weeks after the last dose.

Exclusion Criteria:

  1. Mean trough seated DBP ≥ 110 mmHg at randomization.
  2. Have a known secondary cause of hypertension, including but not limited to: renal artery stenosis, coarctation of the aorta, uncontrolled or untreated hyperthyroidism/hypothyroidism, pheochromocytoma, or Cushing's syndrome.
  3. History of adrenal insufficiency at screening.
  4. Presence of severe structural heart disease at screening, including severe valvular heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, rheumatic heart disease, or congenital heart disease.
  5. Presence of persistent atrial fibrillation or any arrhythmia requiring treatment at screening; or resting heart rate < 45 bpm or > 110 bpm.
  6. New York Heart Association (NYHA) Class III-IV heart failure at screening.
  7. Undergone CT angiography (CTA) or colonoscopy within 1 month prior to screening.
  8. Undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 6 months prior to screening, or plan to undergo PCI, CABG, carotid or peripheral artery revascularization during the study period.
  9. History of stroke, acute coronary syndrome, hypertensive encephalopathy, or hospitalization for heart failure within 6 months prior to screening.
  10. Within 6 months prior to screening, presence of clinically significant diseases in the following systems that, in the investigator's judgment, may interfere with the study results or pose additional risk to the administration of the investigational product, including but not limited to: respiratory, digestive, endocrine, immune, urinary, hematologic, neurologic, or psychiatric disorders.
  11. History of malignancy within 5 years prior to screening.
  12. Use of strong inhibitors/inducers of cytochrome P450 3A4 (CYP3A4) within 1 week prior to screening ,or moderate inhibitors/inducers.
  13. Use of mineralocorticoid receptor antagonists (MRAs) and/or potassium-sparing diuretics (e.g., spironolactone, eplerenone, finerenone, amiloride, triamterene, etc.) within 4 weeks prior to randomization.
  14. Use of aldosterone synthase inhibitors (ASIs) within 4 weeks prior to randomization.
  15. Concomitant use of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) within 4 weeks prior to randomization.
  16. Treatment with potassium binders within 2 months prior to screening.
  17. Presence of any of the following laboratory abnormalities:

    1. eGFR < 45 mL/min/1.73 m² ;
    2. HbA1c > 10.5%;
    3. Serum sodium < 135.0 mmol/L;
    4. ALT ≥ 3 × ULN;
    5. AST ≥ 3 × ULN;
    6. Total bilirubin ≥ 2 × ULN.
  18. Body mass index (BMI) > 35 kg/m².
  19. Run-in period placebo compliance < 80% or > 120% at randomization.
  20. Known or suspected allergy to MRAs, the investigational product, or any of its excipients.
  21. Treatment with any other investigational product within 90 days or 5 half-lives prior to screening .
  22. Women of childbearing potential (WOCBP) who are pregnant, breastfeeding, plan to become pregnant during the study, or are unable to use highly effective contraceptive measures; or male participants who are unable to use highly effective contraceptive measures.
  23. Occupation or working schedule requiring regular night shifts or similar circumstances that may interfere with study procedures.
  24. Any other condition that, in the investigator's judgment, may compromise participant safety or interfere with the assessment of study results.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Treatment group A: HRS-1780 tablet Dose 1
HRS-1780 tablet Dose 1
HRS-1780 tablet Dose 2
HRS-1780 tablet Dose 3
Experimenteel: Treatment group B: HRS-1780 tablet Dose 2
HRS-1780 tablet Dose 1
HRS-1780 tablet Dose 2
HRS-1780 tablet Dose 3
Experimenteel: Treatment group C: HRS-1780 tablet Dose 3
HRS-1780 tablet Dose 1
HRS-1780 tablet Dose 2
HRS-1780 tablet Dose 3
Placebo-vergelijker: Treatment group D: HRS-1780 tablet placebo
HRS-1780 tablet placebo

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Change from baseline in trough seated SBP at Week 12
Tijdsspanne: baseline and Week 12
baseline and Week 12

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Change from baseline in trough seated DBP at Week 12
Tijdsspanne: baseline and Week 12
baseline and Week 12
Change from baseline in trough seated SBP at Week 8
Tijdsspanne: baseline and Week 8
baseline and Week 8
Proportion of participants achieving trough seated blood pressure < 140/90 mmHg at Week 12
Tijdsspanne: Week 12
Week 12
Proportion of participants achieving trough seated SBP < 130 mmHg at Week 12
Tijdsspanne: Week 12
Week 12
Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean SBP at Week 12
Tijdsspanne: baseline and Week 12
baseline and Week 12
Change from baseline in daytime and nighttime mean SBP measured by 24-hour ABPM at Week 12
Tijdsspanne: baseline and Week 12
baseline and Week 12
Change from baseline in daytime and nighttime mean DBP measured by 24-hour ABPM at Week 12
Tijdsspanne: baseline and Week 12
baseline and Week 12
Change from randomized withdrawal baseline (Week 44) in trough seated SBP at Week 52
Tijdsspanne: Week 44 and Week 52
Week 44 and Week 52
Proportion of participants with eGFR decline ≥ 30% during the treatment period
Tijdsspanne: baseline and treatment period
baseline and treatment period
Proportion of participants with serum potassium > 6.0 mmol/L during the treatment period
Tijdsspanne: treatment period
treatment period
Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean DBP at Week 12
Tijdsspanne: baseline and Week 12
baseline and Week 12
Proportion of participants with serum potassium > 5.5 mmol/L and ≤ 6.0 mmol/L during the treatment period
Tijdsspanne: treatment period
treatment period

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 april 2029

Studie voltooiing (Geschat)

1 april 2029

Studieregistratiedata

Eerst ingediend

13 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

13 juli 2026

Eerst geplaatst (Werkelijk)

16 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 september 2026

Laatste update ingediend die voldeed aan QC-criteria

27 augustus 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • HRS-1780-302

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren