Assess Sacubitril/Allisartan and Amlodipine in Patients With Essential Hypertension Uncontrolled … (NCT07704684) | Clinical Trial Compass
CompletedPhase 3
Assess Sacubitril/Allisartan and Amlodipine in Patients With Essential Hypertension Uncontrolled With Amlodipine
China376 participantsStarted 2023-06-28
Plain-language summary
The main objective of the study will be to assess the efficacy and safety of Sacubitril/Allisartan (240mg) and Amlodipine (5mg) in patients with essential hypertension uncontrolled after 4-week treatment with Amlodipine (5mg).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients 18-75 years old.
. Confirmed diagnosis of essential hypertension.
. Patients who meet one of the following criteria when screening:
. At randomization, subjects must have msSBP ≥140 mmHg and \<180 mmHg.
. Subjects voluntarily participate in the trial and sign the written informed consent form.
. For subjects enrolled for ambulatory blood pressure monitoring (ABPM): in addition to all above inclusion criteria, one further requirement must be satisfied: valid ABPM report with a 24-hour average blood pressure ≥130/80 mmHg. (Subjects failing to meet Criterion 6 remain eligible for the main trial without ABPM testing.)
Exclusion criteria
. Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg).
. History or confirmed diagnosis of secondary hypertension.
. Concomitant use of three or more types of antihypertensive agents.
. Personal history of angioedema induced by drugs or other causes.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The baseline change in mean seated systolic blood pressure (msSBP)
. Clinically significant abnormal laboratory findings, including but not limited to: serum potassium \>5.5 mmol/L or \<3.5 mmol/L; serum ALT and/or AST \>2.5 × upper limit of normal (ULN); serum creatinine \>1.5 × ULN; any other clinically significant laboratory abnormality deemed by the investigator likely to confound efficacy and/or safety assessment of the study.
. Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus .
. Subjects with active malignant tumor.
. History of substance abuse or excessive alcohol consumption within 6 months prior to screening.