NCT07241338Not yet recruitingPhase 4
Sacubitril/Allisartan for Hypertensive Patients With Overweight or Obesity
Sacubitril/Allisartan Versus Amlodipine for Hypertensive Patients With Overweight or Obesity: A Multicenter, Open-Label, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
To compare the efficacy and safety of sacubitril/Allisartan versus amlodipine in the antihypertensive treatment of overweight/obese patients with primary hypertension
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- First submitted
- 13 Nov 2025
- Start date
- Nov 2025
- Primary completion date
- Nov 2026
- Lead sponsor
- Jing Liu
- Diseases
- Obesity, High blood pressure
- NCT number
- NCT07241338
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 104
- From Nov 2025 to the primary completion date, Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients undergoing hemodialysis or strict salt-restriction therapy;
Other illness
- 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;
Lab values
- 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;
- Known or suspected allergy to sacubitril/allisartan, sacubitril/valsartan sodium, amlodipine, or related drugs;
Other
- Patients deemed unsuitable for participation in the study by the investigator.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.