Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Tonlamarsen, Placebo.
- Кому может быть актуально
- Состояния в реестре: Hypertension, Acute Severe Hypertension, Hypertensive Emergency, Hypertensive Urgency. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Two-Part Study to Evaluate the Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension
Обзор
The purpose of this study is to evaluate the blood pressure-lowering effect of tonlamarsen in adult participants who were recently hospitalized and concurrently experienced an episode of acute severe hypertension.
Подробное описание
The Sponsor is studying an investigational medication called tonlamarsen to determine if it can help people recently treated for acute severe hypertension (hypertensive emergency and urgency).
The purpose of this study is to evaluate how well tonlamarsen works compared to a placebo and to see how safe it is for people following a recent episode of acute severe hypertension. Tonlamarsen is designed to block the body's liver from making a protein called angiotensinogen (AGT), which plays a key role in controlling blood pressure.
The main goals of the study are:
* To assess the effect of tonlamarsen on the amount of AGT in blood over time * To assess the effect of tonlamarsen on blood pressure * To evaluate the safety and tolerability of tonlamarsen
Participants will:
* Receive monthly doses of tonlamarsen for approximately 3 months * Visit the clinic about 7 times, including initial evaluation, checkups, tests, and follow-up
Вмешательства
- Препарат Tonlamarsen
Tonlamarsen will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study - Препарат Placebo
Placebo will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study
Первичные конечные точки
- Part A: To assess variability in clinical and biomarker measures to inform Part B sample-size estimation and study-design assumptions [Срок оценки: Baseline through Week 12]
- Part B: To assess the pharmacodynamic (PD) effect of tonlamarsen on plasma AGT levels [Срок оценки: Week 4]
Вторичные конечные точки (8)
- Part A: To assess the safety and tolerability of tonlamarsen compared with placebo [Срок оценки: Week 36]
- Part A: To assess the feasibility of using AGT levels and systolic blood pressure as efficacy endpoints [Срок оценки: Baseline through Week 12]
- Part B: To assess the safety and tolerability of tonlamarsen compared with placebo [Срок оценки: Week 36]
- Part B: To evaluate the effect of tonlamarsen on systolic blood pressure measured via daily home blood pressure monitoring [Срок оценки: Week 4]
- Part B: To evaluate the effect of tonlamarsen on office systolic blood pressure [Срок оценки: Week 4]
- Part B: To assess the PD effect of tonlamarsen on plasma AGT levels [Срок оценки: Week 12]
- Part B: To evaluate the effect of tonlamarsen on systolic blood pressure measured via daily home blood pressure monitoring [Срок оценки: Week 12]
- Part B: To evaluate the effect of tonlamarsen on office systolic blood pressure [Срок оценки: Week 12]
Критерии участия
Критерии включения
- Age 18 or older, body weight ≥ 50 kg with BMI ≤45.0 kg/m2
- Ready for discharge or recently discharged from the hospital to home (within the past 7 days) during which evaluation and/or treatment of acute severe hypertension (documented SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg) occurred, as measured by a healthcare provider (HCP) within the 24 hours preceding hospitalization or during the initial 24 hours of hospitalization
- At Screening and Randomization visit, average resting office systolic blood pressure ≥ 145 mmHg
- Presence of established cardiovascular or renal disease
Критерии исключения
- Has known history of secondary hypertension
- Any malignancy requiring treatment within 5 years (except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated)
- Has abnormal thyroid function with clinical significance
- Recent hospitalization for stroke, myocardial infarction or coronary revascularization within 30 days prior to screening
- History of and/or obvious clinical signs or symptoms of cirrhosis or other significant liver disease
- Alanine aminotransferase or aspartate aminotransferase >2 x upper limit of normal
- Most recent hospitalization was for non-cardiovascular or non-renal conditions
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
США · 8 центров
- Western Nephrology and Metabolic Bone Disease, PC - Arvada — Arvada
- Homestead Associates in Research — Homestead
- Progressive Medical Research — Port Orange
- Richmond University Medical Center (RUMC) — Staten Island
- Research Innovations, LLC — Beavercreek
- Chattanooga Research & Medicine CHARM — Chattanooga
- Laguna Clinical Research Associates — Laredo
- Baylor Scott and White Research Institute - Temple — Temple
Идентификаторы
NCT: NCT07511361 · TLA-202