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Clinical Trials in China / NCT07241338
Starting soon Phase 4

Sacubitril/Allisartan for Hypertensive Patients With Overweight or Obesity

NCT07241338 · tracked via the Priya Life Science China tracker
Sponsor
Jing Liu
Phase
Phase 4
Started
2025-11
Last updated
2025-11-21

Condition(s) studied

Hypertension

Investigational drug(s) / intervention(s)

sacubitril/allisartanAmlodipine

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

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Aged between 18 and 75 years inclusive, regardless of gender; 2. Body Mass Index (BMI) ≥ 24 kg/m²; 3. Diagnosed with essential hypertension, either untreated or currently receiving antihypertensive medication; 4. 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; 5. 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. Exclusion Criteria: 1. Severe hypertension (msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg); malignant hypertension, etc.; 2. History of or diagnostic evidence for obstructive sleep apnea (OSA); 3. History of angioedema; 4. History of or diagnostic evidence for secondary hypertension; 5. 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; 6. 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); 7. Type 1 diabetes mellitus and type 2 diabetes mellitus with poor glycemic control (glycated hemoglobin (HbA1c) \> 8.0%); 8. Patients currently using drugs with weight-loss effects such as glucagon-like peptide-1 (GLP-1) and sodium-glucose cotransporter 2 (SGLT-2) inhibitors; 9. Patients undergoing hemodialysis or strict salt-restriction therapy; 10. Known or suspected allergy to sacubitril/allisartan, sacubitril/valsartan sodium, amlodipine, or related drugs; 11. Patients deemed unsuitable for participation in the study by the investigator.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University People's Hospital Beijing China

On this site

📄 Norvasc (amlodipine) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07241338 on ClinicalTrials.gov ↗ ← All trials in China