Loading clinical trials...
Loading clinical trials...
Sacubitril/Allisartan Versus Amlodipine for Hypertensive Patients With Overweight or Obesity: A Multicenter, Open-Label, Randomized Controlled Trial
To compare the efficacy and safety of sacubitril/Allisartan versus amlodipine in the antihypertensive treatment of overweight/obese patients with primary hypertension
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Peking University People's Hospital
Beijing, China
Start Date
November 1, 2025
Primary Completion Date
November 1, 2026
Completion Date
June 1, 2027
Last Updated
November 21, 2025
104
ESTIMATED participants
sacubitril/allisartan
DRUG
Amlodipine
DRUG
Lead Sponsor
Jing Liu
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions