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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115088
Enrollment
Unknown
Registered
2025-12-22
Start date
2025-12-22
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to moderate essential hypertension AND overweight or obese

Interventions

Amlodipine tablet group:Take 5mg of amlodipine orally
Sacubitril arisartan group:Take 240mg of sacubitril arrisartan orally

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 75 years old, gender not limited; 2. BMI>=24kg/m^2; 3. Diagnosed with essential hypertension, not receiving treatment or currently undergoing antihypertensive drug treatment; 4.For patients who have not received antihypertensive drug treatment in the past three months, during the screening visit, the mean sitting systolic blood pressure (msSBP) must be greater than or equal to 150mmHg and less than 180mmHg. 5.For patients currently undergoing antihypertensive drug treatment, during the screening visit, they must meet the criteria of msSBP>=140mmHg and <180mmHg. At the end of the elution period during the visit, the balance must be met The mean sitting systolic blood pressure (msSBP) is greater than or equal to 150mmHg and less than 180mmHg.

Exclusion criteria

Exclusion criteria: 1.Severe hypertension (msSBP>=180mmHg, and/or msDBP>=110mmHg); Malignant hypertension, etc. 2. Have a history of obstructive sleep apnea (OSA) or a basis for diagnosis; 3. Have a history of angioedema; 4. Have a history or diagnostic basis of secondary hypertension; 5. Hypertension complicated with the following lesions: acute coronary syndrome occurring within 12 months, myocardial infarction, percutaneous coronary intervention, stroke; NYHA grade II-IV heart failure, large aneurysms or dissecting aneurysms, second-degree or above atrioventricular block, sick sinus syndrome, bradycardia (heart rate 5.5 mmoL/L or 2.5× upper limit of normal (ULN); Blood creatinine > 1.5×ULN; 7.1 Type diabetes and poorly controlled type 2 diabetes (HbA1c > 8.0%); 8. Patients who are currently using weight-loss drugs such as GLP-1 and SGLT-2; 9. Patients undergoing hemodialysis or strict salt restriction therapy; 10. Known or suspected allergy to sacubitril arrisartan, sacubitril valsartan sodium or amlodipine and related drugs; 11. Patients who were evaluated by the researchers as unsuitable to participate in the study;

Design outcomes

Primary

MeasureTime frame
Mean sitting systolic blood pressure(msSBP);

Secondary

MeasureTime frame
Blood routine;Average nocturnal ambulatory blood pressure;Vital signs;Mean sitting diastolic blood pressure(msDBP);Urine routine;Blood biochemistry;Urinary albumin/creatinine ratio (UACR);Average daily ambulatory blood pressure;24-hour average ambulatory blood pressure;

Countries

China

Contacts

Public ContactJing Liu

Peking University People's Hospital

heartcenter@163.com+86 10 88325457

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026