Sacubitril/Allisartan for Hypertensive Patients With Overweight or Obesity

Официальное название

Sacubitril/Allisartan Versus Amlodipine for Hypertensive Patients With Overweight or Obesity: A Multicenter, Open-Label, Randomized Controlled Trial

Обзор

To compare the efficacy and safety of sacubitril/Allisartan versus amlodipine in the antihypertensive treatment of overweight/obese patients with primary hypertension

Подробное описание

This study is a prospective, randomized, controlled, open-label trial conducted in overweight/obese patients with primary mild-to-moderate hypertension, aiming to compare the efficacy and safety of sacubitril/Allisartan versus amlodipine treatment.

The study consists of two phases: a washout period (maximum 2 weeks, for patients currently receiving antihypertensive medication) and a treatment period (8 weeks). Patients already on antihypertensive therapy must complete a 2-week washout period (i.e., discontinue antihypertensive treatment), while those with no prior history of antihypertensive medication use are exempt from the washout.

All patients undergo eligibility assessment against inclusion and exclusion criteria before randomization. Eligible patients are randomly assigned in a 1:1 ratio to sacubitril/Allisartan group or Amlodipine group. In sacubitril/Allisartan group, oral administration of sacubitril/Allisartan 240mg once daily for 4 consecutive weeks. If blood pressure reaches the target, the original regimen is continued; otherwise, the dose of sacubitril/Allisartan is increased to 480mg once daily for another 4 weeks of treatment. In Amlodipine group, oral administration of amlodipine 5mg once daily for 4 consecutive weeks. If blood pressure reaches the target, the original regimen is continued; otherwise, the dose of amlodipine is increased to 10mg once daily for another 4 weeks of treatment.

The total treatment period is 8 weeks of oral medication. Patients will attend study visits on the day before treatment initiation (Day 0), at the end of Week 4, and at the end of Week 8 of the treatment period for efficacy and safety assessments, respectively.

Вмешательства

• Препарат sacubitril/allisartan
  Oral administration of sacubitril/allisartan 240mg once daily for 4 consecutive weeks. If blood pressure reaches the target, the original regimen is continued; otherwise, the dose of sacubitril/valsartan is increased to 480mg once daily for another 4 weeks of treatment
• Препарат Amlodipine
  Amlodipine group: Oral administration of amlodipine 5mg once daily for 4 consecutive weeks. If blood pressure reaches the target, the original regimen is continued; otherwise, the dose of amlodipine is increased to 10mg once daily for another 4 weeks of treatment

Первичные конечные точки

• The change in the mean sitting systolic blood pressure (msSBP) from baseline to week 8, assessed for sacubitril/allisartan as compared to amlodipine [Срок оценки: From the start of randomization to the end of treatment at 8 weeks]

Вторичные конечные точки (7)

• The change in the mean sitting diastolic blood pressure (msSBP) from baseline to week 8, assessed for sacubitril/allisartan as compared to amlodipine [Срок оценки: From the start of randomization to the end of treatment at 8 weeks]
• The BP control rate of sacubitril/allisartan compared to amlodipine [Срок оценки: From the start of randomization to the end of treatment at 4 weeks and 8 weeks]
• The BP response rate of sacubitril/allisartan compared to amlodipine [Срок оценки: From the start of randomization to the end of treatment at 8 weeks]
• Changes in 24-hour mean ambulatory systolic and diastolic blood pressures of sacubitril/allisartan compared to amlodipine [Срок оценки: From the start of randomization to the end of treatment at 8 weeks]
• Changes in daytime and night-time mean ambulatory blood pressures of sacubitril/allisartan compared to amlodipine [Срок оценки: From the start of randomization to the end of treatment at 8 weeks]
• Changes in circadian rhythm of blood pressure between sacubitril/allisartan compared to amlodipine [Срок оценки: From the start of randomization to the end of treatment at 8 weeks]
• Safety assessments between sacubitril/allisartan compared to amlodipine [Срок оценки: From the start of randomization to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

• Aged between 18 and 75 years inclusive, regardless of gender;
• Body Mass Index (BMI) ≥ 24 kg/m²;
• Diagnosed with essential hypertension, either untreated or currently receiving antihypertensive medication;
• For patients who have not received antihypertensive medication in the past 3 months, the msSBP at the screening visit must be ≥ 150 mmHg and < 180 mmHg;
• For patients currently receiving antihypertensive medication, the msSBP at the screening visit must be ≥ 140 mmHg and < 180 mmHg; and at the visit after the washout period, the msSBP must be ≥ 150 mmHg and < 180 mmHg.

Критерии исключения

• Severe hypertension (msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg); malignant hypertension, etc.;
• History of or diagnostic evidence for obstructive sleep apnea (OSA);
• History of angioedema;
• History of or diagnostic evidence for secondary hypertension;
• Hypertension complicated with the following conditions: acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, or stroke occurring within 12 months; New York Heart Association (NYHA) Class II-IV heart failure, large aortic aneurysm or aortic dissection, atrioventricular block of degree II or higher, sick sinus syndrome, bradycardia (heart rate < 50 beats per minute) or other arrhythmias requiring antiarrhythmic drugs, as well as severe diseases such as epilepsy and syncope;
• Clinically significant abnormalities in laboratory tests (serum potassium > 5.5 mmol/L or < 3.5 mmol/L; serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2.5 × upper limit of normal (ULN); serum creatinine > 1.5 × ULN);
• Type 1 diabetes mellitus and type 2 diabetes mellitus with poor glycemic control (glycated hemoglobin (HbA1c) > 8.0%);
• Patients currently using drugs with weight-loss effects such as glucagon-like peptide-1 (GLP-1) and sodium-glucose cotransporter 2 (SGLT-2) inhibitors;
• Patients undergoing hemodialysis or strict salt-restriction therapy;
• Known or suspected allergy to sacubitril/allisartan, sacubitril/valsartan sodium, amlodipine, or related drugs;
• Patients deemed unsuitable for participation in the study by the investigator.

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT07241338 · 2025PHB414

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗