A Trial of HRS-1780 in Participants With Uncontrolled Hypertension or Resistant Hypertension.
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.
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Phase 2
- Phase 3
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Xue Dong
- Telefonnummer: 13511659605
- E-Mail: xue.dong@hengrui.com
Studieren Sie die Kontaktsicherung
- Name: Ru Lin
- Telefonnummer: 15521381683
- E-Mail: ru.lin.rl7@hengrui.com
Studienorte
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 400042
- Army Characteristic Medical Center of the People's Liberation Army
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Hauptermittler:
- Chunyu Zeng
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200080
- Zhongshan hospital, Fudan university
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Hauptermittler:
- Xiaoqiang Ding
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Male or female, aged ≥ 18 and < 80 years ;
- Mean trough seated SBP ≥ 140 mmHg and < 170 mmHg at both screening and randomization visits.
Meet one of the following two criteria:
- Meet the criteria for uncontrolled hypertension;
- Meet the criteria for resistant hypertension;
- Serum potassium ≥ 3.5 mmol/L and ≤ 5.0 mmol/L ;
- Voluntarily sign the ICF prior to the study;
- Have no plan for fertility from the time of signing the ICF until 4 weeks after the last dose.
Exclusion Criteria:
- Mean trough seated DBP ≥ 110 mmHg at randomization.
- 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.
- History of adrenal insufficiency at screening.
- Presence of severe structural heart disease at screening, including severe valvular heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, rheumatic heart disease, or congenital heart disease.
- Presence of persistent atrial fibrillation or any arrhythmia requiring treatment at screening; or resting heart rate < 45 bpm or > 110 bpm.
- New York Heart Association (NYHA) Class III-IV heart failure at screening.
- Undergone CT angiography (CTA) or colonoscopy within 1 month prior to screening.
- 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.
- History of stroke, acute coronary syndrome, hypertensive encephalopathy, or hospitalization for heart failure within 6 months prior to screening.
- 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.
- History of malignancy within 5 years prior to screening.
- Use of strong inhibitors/inducers of cytochrome P450 3A4 (CYP3A4) within 1 week prior to screening ,or moderate inhibitors/inducers.
- 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.
- Use of aldosterone synthase inhibitors (ASIs) within 4 weeks prior to randomization.
- Concomitant use of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) within 4 weeks prior to randomization.
- Treatment with potassium binders within 2 months prior to screening.
Presence of any of the following laboratory abnormalities:
- eGFR < 45 mL/min/1.73 m² ;
- HbA1c > 10.5%;
- Serum sodium < 135.0 mmol/L;
- ALT ≥ 3 × ULN;
- AST ≥ 3 × ULN;
- Total bilirubin ≥ 2 × ULN.
- Body mass index (BMI) > 35 kg/m².
- Run-in period placebo compliance < 80% or > 120% at randomization.
- Known or suspected allergy to MRAs, the investigational product, or any of its excipients.
- Treatment with any other investigational product within 90 days or 5 half-lives prior to screening .
- 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.
- Occupation or working schedule requiring regular night shifts or similar circumstances that may interfere with study procedures.
- Any other condition that, in the investigator's judgment, may compromise participant safety or interfere with the assessment of study results.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
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Experimental: Treatment group A: HRS-1780 tablet Dose 1
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HRS-1780 tablet Dose 1
HRS-1780 tablet Dose 2
HRS-1780 tablet Dose 3
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Experimental: Treatment group B: HRS-1780 tablet Dose 2
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HRS-1780 tablet Dose 1
HRS-1780 tablet Dose 2
HRS-1780 tablet Dose 3
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Experimental: Treatment group C: HRS-1780 tablet Dose 3
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HRS-1780 tablet Dose 1
HRS-1780 tablet Dose 2
HRS-1780 tablet Dose 3
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Placebo-Komparator: Treatment group D: HRS-1780 tablet placebo
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HRS-1780 tablet placebo
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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Change from baseline in trough seated SBP at Week 12
Zeitfenster: baseline and Week 12
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baseline and Week 12
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Change from baseline in trough seated DBP at Week 12
Zeitfenster: baseline and Week 12
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baseline and Week 12
|
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Change from baseline in trough seated SBP at Week 8
Zeitfenster: baseline and Week 8
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baseline and Week 8
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Proportion of participants achieving trough seated blood pressure < 140/90 mmHg at Week 12
Zeitfenster: Week 12
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Week 12
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Proportion of participants achieving trough seated SBP < 130 mmHg at Week 12
Zeitfenster: Week 12
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Week 12
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Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean SBP at Week 12
Zeitfenster: baseline and Week 12
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baseline and Week 12
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Change from baseline in daytime and nighttime mean SBP measured by 24-hour ABPM at Week 12
Zeitfenster: baseline and Week 12
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baseline and Week 12
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Change from baseline in daytime and nighttime mean DBP measured by 24-hour ABPM at Week 12
Zeitfenster: baseline and Week 12
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baseline and Week 12
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Change from randomized withdrawal baseline (Week 44) in trough seated SBP at Week 52
Zeitfenster: Week 44 and Week 52
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Week 44 and Week 52
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Proportion of participants with eGFR decline ≥ 30% during the treatment period
Zeitfenster: baseline and treatment period
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baseline and treatment period
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Proportion of participants with serum potassium > 6.0 mmol/L during the treatment period
Zeitfenster: treatment period
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treatment period
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Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean DBP at Week 12
Zeitfenster: baseline and Week 12
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baseline and Week 12
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Proportion of participants with serum potassium > 5.5 mmol/L and ≤ 6.0 mmol/L during the treatment period
Zeitfenster: treatment period
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treatment period
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Mitarbeiter und Ermittler
Sponsor
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- HRS-1780-302
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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