A Phase II Clinical Study on the Efficacy and Safety of HRS-1780 in Participants With Primary Aldosteronism

Официальное название

A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-1780 in Participants With Primary Aldosteronism

Обзор

This study is a multicenter, randomized, double-blind, placebo-parallel-controlled phase II clinical trial to evaluate the efficacy and safety of HRS-1780 compared with placebo in participants with primary aldosteronism. The study plans to enroll 60 participants.

Вмешательства

• Препарат HRS-1780 Tablets
  HRS-1780 Tablets
• Препарат Placebo
  Placebo

Первичные конечные точки

• Change from baseline in office systolic blood pressure (SBP); [Срок оценки: up to Week 8]

Вторичные конечные точки (10)

• Rate of achieving office blood pressure <140/90 mmHg; [Срок оценки: up to Week 8]
• Rate of achieving office blood pressure <130/80 mmHg; [Срок оценки: up to Week 8]
• Change from baseline in office diastolic blood pressure (DBP) ; [Срок оценки: up to Week 8]
• Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean SBP and DBP ; [Срок оценки: up to Week 8]
• Change from baseline in 24-hour ABPM daytime and nighttime SBP and DBP ; [Срок оценки: up to Week 8]
• Change from baseline in serum potassium (K+) and serum sodium ; [Срок оценки: Weeks 2, 4, and 8]
• Total cumulative dose of potassium supplement (potassium chloride) ; [Срок оценки: up to Week 8]
• Proportion of participants with a ≥30% decline in estimated glomerular filtration rate (eGFR); [Срок оценки: up to Week 8]
• Proportion of participants with 5.5 < K+ ≤ 6.0 mmol/L; [Срок оценки: up to Week 8]
• Proportion of participants with K+ > 6.0 mmol/L; [Срок оценки: up to Week 8]

Критерии участия

Критерии включения

• Male or female, aged ≥ 18 years on the date of signing the informed consent form.
• Diagnosed with primary aldosteronism.
• No use of antihypertensive drugs before screening, or stable use of antihypertensive drugs.
• Voluntarily sign the informed consent form before the trial, fully understand the trial content, procedures, and possible adverse reactions, and be capable and willing to comply with the protocol requirements to complete the study.
• From the signing of the informed consent form until 4 weeks after the last dose, the participant has no plan for procreation and is willing to adopt the highly effective contraceptive measures specified in the protocol.

Критерии исключения

• Has known secondary causes of hypertension.
• Has previously undergone, or plans to undergo during the study period, adrenal-related surgeries, including adrenalectomy, adrenal ablation, etc.
• Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m².
• Has had any malignancy of an organ system within 5 years before screening.
• Has received any other investigational drug within 90 days or 5 half-lives before screening (whichever is longer).
• Has a history of blood donation or blood loss ≥ 400 mL within 3 months before screening, or has received a blood transfusion within 2 months.
• Known or suspected alcohol or narcotic abuse.
• Women who are pregnant, breastfeeding, planning pregnancy, or of childbearing potential unable to adopt highly effective contraceptive measures; or men unable to adopt highly effective contraceptive measures.
• Abnormal daily routine.
• Use of strong inhibitors/inducers of cytochrome P450 3A4 (CYP3A4) within 1 week before randomization.
• Severe infection, severe trauma, or major or medium-scale surgery within 1 month prior to screening;
• Stroke, transient ischemic attack, myocardial infarction, symptomatic heart failure (NYHA III-IV), or coronary revascularization within 3 months prior to screening; and/or planned coronary, carotid, or peripheral artery revascularization at the time of screening;
• Within 6 months prior to the screening period, participants have clinically significant diseases that, in the judgment of the investigator, may interfere with the trial results or pose additional risks to the administration of the study drug, including but not limited to respiratory, digestive, cardiovascular, endocrine, immune, urinary, adrenal (except for the primary disease), hematological, neurological, psychiatric, or other conditions;
• Presence or suspected presence of depression, bipolar disorder, suicidal tendencies, schizophrenia, or other severe mental disorders; or participants with mental incapacity or language barriers that prevent them from adequately understanding or participating in the trial process;
• Alanine aminotransferase (ALT) ≥ 3 × upper limit of normal (ULN);
• Aspartate aminotransferase (AST) ≥ 3 × ULN;
• In the judgment of the investigator, any condition that may affect participant safety or otherwise interfere with the evaluation of trial results (including medical, psychological, social, or geographical factors).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу

Идентификаторы

NCT: NCT07470983 · HRS-1780-203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗