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

13. juli 2026 opdateret af: 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。

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

914

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina, 400042
        • Army Characteristic Medical Center of the People's Liberation Army
        • Ledende efterforsker:
          • Chunyu Zeng
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200080
        • Zhongshan Hospital, Fudan University
        • Ledende efterforsker:
          • Xiaoqiang Ding

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Treatment group A: HRS-1780 tablet Dose 1
HRS-1780 tablet Dose 1
HRS-1780 tablet Dose 2
HRS-1780 tablet Dose 3
Eksperimentel: Treatment group B: HRS-1780 tablet Dose 2
HRS-1780 tablet Dose 1
HRS-1780 tablet Dose 2
HRS-1780 tablet Dose 3
Eksperimentel: Treatment group C: HRS-1780 tablet Dose 3
HRS-1780 tablet Dose 1
HRS-1780 tablet Dose 2
HRS-1780 tablet Dose 3
Placebo komparator: Treatment group D: HRS-1780 tablet placebo
HRS-1780 tablet placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline in trough seated SBP at Week 12
Tidsramme: baseline and Week 12
baseline and Week 12

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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. juli 2026

Primær færdiggørelse (Anslået)

1. april 2029

Studieafslutning (Anslået)

1. april 2029

Datoer for studieregistrering

Først indsendt

13. juli 2026

Først indsendt, der opfyldte QC-kriterier

13. juli 2026

Først opslået (Faktiske)

16. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • HRS-1780-302

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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Kliniske forsøg med HRS-1780 tablet

3
Abonner