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Предстои набиране Фаза 2 NCT07550465

Study of QLS1410 in the Treatment of Primary Aldosteronism.

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Primary Aldosteronism

Спонсор: Qilu Pharmaceutical Co., Ltd.

Налично на: БГ
Обобщение
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of QLS1410 versus placebo, on the reduction of Seated Blood Pressure (SBP) in participants ≥ 18 years of age with Primary Aldosteronism (PA) with or without prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics. QLS1410 (or placebo) will be administered once daily, up-titrated after 2 weeks or 4 weeks based on clinical response and tolerability.
Кой може да участва
Inclusion Criteria: 1. Male or female participants must be ≥ 18 years of age 2. Participants with a documented diagnosis of primary aldosteronism (PA) that fulfils the criteria Guidelines. 3. Participants willing and able to cease dosing of mineralocorticoid receptor antagonist (MRA) or potassium sparing diuretics per study requirement for participants taking an MRA or potassium sparing diuretic at Screening. 4. eGFR ≥ 45 mL/min/1.73m2 at Screening 5. Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomization Exclusion Criteria: 1. Had undergone surgery for adrenal adenoma in the past or planned to receive surgical treatments such as adrenalectomy, renal sympathetic denervation, or adrenal ablation during the course of the study. 2. Has the following known secondary causes of HTN: renal artery stenosis, uncontrolled or untreated hyperthyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation. 3. Treatment with any MRA or potassium-sparing diuretic within 2 weeks prior to Randomization.
Интервенции
QLS1410
DRUG
Placebo
DRUG
Места на провеждане

Информация за локации не е налична.

Технически детайли
Статус
Предстои набиране
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
01.06.2026
Крайна дата
01.04.2027
Регистрационен номер
NCT07550465
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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