HypertensionPhase 4SHOTNCT07241338
Sacubitril/Allisartan for Hypertensive Patients With Overweight or Obesity
A Phase 4 study testing sacubitril/allisartan and Amlodipine in people with Hypertension, run by Jing Liu at 1 site in China.
Trial summary
To compare the efficacy and safety of sacubitril/Allisartan versus amlodipine in the antihypertensive treatment of overweight/obese patients with primary hypertension Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- sacubitril/allisartan and Amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- Nov 2025to Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- 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);
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- 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;
- Patients undergoing hemodialysis or strict salt-restriction therapy;
- Known or suspected allergy to sacubitril/allisartan, sacubitril/valsartan sodium, amlodipine, or related drugs;
- Patients deemed unsuitable for participation in the study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing
Jing Liu, +8610 88325457, heartcenter@163.com
About this study
Official title: 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
Read the detailed description
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.
- Conditions
- Hypertension
- Being tested
- sacubitril/allisartan, Amlodipine
- Keywords
- obesity, overweight, hypertension, sacubitril/Allisartan
- Medical subject headings
- Hypertension, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacubitril/allisartanDrug
Also called angiotensin receptor neprilysin inhibitor, ARNI
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
AmlodipineDrug
Also called calcium channel blocker, CCB
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 group | Role | What they receive |
|---|---|---|
| Sacubitril/Allisartan | Experimental | Not described Receives: Drug: sacubitril/allisartan |
| Amlodipine | Active comparator | Not described Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the mean sitting systolic blood pressure (msSBP) from baseline to week 8, assessed for sacubitril/allisartan as compared to amlodipine
Measured: From the start of randomization to the end of treatment at 8 weeks
Secondary outcomes (7)
The change in the mean sitting diastolic blood pressure (msSBP) from baseline to week 8, assessed for sacubitril/allisartan as compared to amlodipine
Measured: From the start of randomization to the end of treatment at 8 weeks
The BP control rate of sacubitril/allisartan compared to amlodipine
BP control was defined as msSBP/msDBP < 140/90mmHg
Measured: From the start of randomization to the end of treatment at 4 weeks and 8 weeks
The BP response rate of sacubitril/allisartan compared to amlodipine
The percentage of patients who had a successful response after treatment for msSBP (<140 mmHg or a reduction by ≥20 mmHg from baseline) and msDBP (<90 mmHg or a reduction by ≥10 mmHg from baseline)
Measured: From the start of randomization to the end of treatment at 8 weeks
Changes in 24-hour mean ambulatory systolic and diastolic blood pressures of sacubitril/allisartan compared to amlodipine
Measured: From the start of randomization to the end of treatment at 8 weeks
Changes in daytime and night-time mean ambulatory blood pressures of sacubitril/allisartan compared to amlodipine
Measured: From the start of randomization to the end of treatment at 8 weeks
Changes in circadian rhythm of blood pressure between sacubitril/allisartan compared to amlodipine
Measured: From the start of randomization to the end of treatment at 8 weeks
Safety assessments between sacubitril/allisartan compared to amlodipine
Number of participants with adverse events (AEs), serious AEs (SAE), adverse drug reactions (ADR), with abnormal vital signs, abnormal physical exam findings, abnormal laboratory tests results
Measured: From the start of randomization to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jing Liu, Peking University People's Hospital
- Investigators
- Jing Liu, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241338
- Sponsor's protocol ID
- 2025PHB414
- Acronym
- SHOT
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacubitril/Allisartan Versus Amlodipine for Hypertensive Patients With Overweight or Obesity: A Multicenter, Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07241338
- Acronym / sponsor ID
- SHOT / 2025PHB414
- Conditions
- Hypertension
- Keywords
- obesity, overweight, hypertension, sacubitril/Allisartan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Jing LiuUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy and safety of sacubitril/Allisartan versus amlodipine in the antihypertensive treatment of overweight/obese patients with primary hypertension
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacubitril/Allisartan | Experimental | Drug: sacubitril/allisartan |
| Amlodipine | Active comparator | Drug: Amlodipine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sacubitril/allisartanAlso: angiotensin receptor neprilysin inhibitor, ARNIOral 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 | Drug | Sacubitril/Allisartan |
| AmlodipineAlso: calcium channel blocker, CCBAmlodipine 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 | Drug | Amlodipine |
Primary outcome
The change in the mean sitting systolic blood pressure (msSBP) from baseline to week 8, assessed for sacubitril/allisartan as compared to amlodipine
Time frame: From the start of randomization to the end of treatment at 8 weeks
7 secondary outcomes
The change in the mean sitting diastolic blood pressure (msSBP) from baseline to week 8, assessed for sacubitril/allisartan as compared to amlodipine
Time frame: From the start of randomization to the end of treatment at 8 weeks
The BP control rate of sacubitril/allisartan compared to amlodipine
Time frame: From the start of randomization to the end of treatment at 4 weeks and 8 weeks
The BP response rate of sacubitril/allisartan compared to amlodipine
Time frame: From the start of randomization to the end of treatment at 8 weeks
Changes in 24-hour mean ambulatory systolic and diastolic blood pressures of sacubitril/allisartan compared to amlodipine
Time frame: From the start of randomization to the end of treatment at 8 weeks
Changes in daytime and night-time mean ambulatory blood pressures of sacubitril/allisartan compared to amlodipine
Time frame: From the start of randomization to the end of treatment at 8 weeks
Changes in circadian rhythm of blood pressure between sacubitril/allisartan compared to amlodipine
Time frame: From the start of randomization to the end of treatment at 8 weeks
Safety assessments between sacubitril/allisartan compared to amlodipine
Time frame: From the start of randomization to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Liu, MD principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sacubitril/allisartan and Amlodipine in people with Hypertension, run by Jing Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Liu, MD (+8610 88325457, heartcenter@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the mean sitting systolic blood pressure (msSBP) from baseline to week 8, assessed for sacubitril/allisartan as compared to amlodipine (time frame: From the start of randomization to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.