Essential HypertensionPhase 3NCT07704684
Assess Sacubitril/Allisartan and Amlodipine in Patients With Essential Hypertension Uncontrolled With Amlodipine
A Phase 3 study testing Experimental: Sacubitril/Allisartan and Amlodipine Group and Active Comparator: Amlodipine Group in people with Essential Hypertension, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The main objective of the study will be to assess the efficacy and safety of Sacubitril/Allisartan (240mg) and Amlodipine (5mg) in patients with essential hypertension uncontrolled after 4-week treatment with Amlodipine (5mg). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Experimental: Sacubitril/Allisartan and Amlodipine Group and Active Comparator: Amlodipine Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2023to 8 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Patients 18-75 years old.
- Confirmed diagnosis of essential hypertension.
- Patients who meet one of the following criteria when screening:
- Treatment-naive patients (newly diagnosed essential hypertension, or patients with a prior hypertension history who have not taken any antihypertensive medication for at least 4 weeks prior to screening): mean seated systolic blood pressure (msSBP) ≥150 mmHg and <180 mmHg.
- Patients with irregular oral administration of amlodipine besylate (5 mg once daily) (treatment duration less than 4 weeks before screening, or more than 5 missed dosing days within the 4 weeks prior to screening): msSBP ≥140 mmHg and<180 mmHg.
- Patients on existing stable antihypertensive therapy (receiving a stable dose of another single-agent antihypertensive, free combination of two single-agent drugs, or single-pill fixed-dose combination containing two active ingredients for at least 4 weeks prior to screening): msSBP ≥140 mmHg and <180 mmHg, and the physician determines that switching treatment to amlodipine besylate (5 mg once daily) is clinically appropriate.
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- Patients with essential hypertension who have been regularly treated with amlodipine besylate (5mg once daily) for ≥4 weeks and have msSBP ≥140 mmHg and<180 mmHg. The previously regularly administered product shall be Norvasc® or generic amlodipine besylate that has passed the generic consistency evaluation in China.
- At randomization, subjects must have msSBP ≥140 mmHg and <180 mmHg.
- Subjects voluntarily participate in the trial and sign the written informed consent form.
- For subjects enrolled for ambulatory blood pressure monitoring (ABPM): in addition to all above inclusion criteria, one further requirement must be satisfied: valid ABPM report with a 24-hour average blood pressure ≥130/80 mmHg. (Subjects failing to meet Criterion 6 remain eligible for the main trial without ABPM testing.)
Who cannot join
- Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg).
- History or confirmed diagnosis of secondary hypertension.
- Concomitant use of three or more types of antihypertensive agents.
- Personal history of angioedema induced by drugs or other causes.
- Clinically significant abnormal laboratory findings, including but not limited to: serum potassium >5.5 mmol/L or <3.5 mmol/L; serum ALT and/or AST >2.5 × upper limit of normal (ULN); serum creatinine >1.5 × ULN; any other clinically significant laboratory abnormality deemed by the investigator likely to confound efficacy and/or safety assessment of the study.
- Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus .
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- Subjects with active malignant tumor.
- History of substance abuse or excessive alcohol consumption within 6 months prior to screening.
- Blood donation or major blood loss (>400 mL) within 3 months prior to screening, or clinically diagnosed hypovolemia.
- Participation in any interventional clinical trial with investigational medicinal product or medical device within 3 months prior to screening.
- Drug compliance during run-in period <80% or >120%.
- Any other conditions deemed inappropriate for trial enrollment by the investigator that may interfere with efficacy and/or safety evaluation of the study, including but not limited to anticipated poor subject compliance or impractical regular follow-up due to long residential distance.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Efficacy and Safety of Sacubitril/Allisartan and Amlodipine in Patients With Essential Hypertension Uncontrolled With Amlodipine: A Phase III, Multicenter, Randomized, Double-blind, Parallel-controlled, 52-week Clinical Study
The main objective of the study will be to assess the efficacy and safety of Sacubitril/Allisartan (240mg) and Amlodipine (5mg) in patients with essential hypertension uncontrolled after 4-week treatment with Amlodipine (5mg).
- Conditions
- Essential Hypertension
- Being tested
- Experimental: Sacubitril/Allisartan and Amlodipine Group, Active Comparator: Amlodipine Group
- Keywords
- Hypertension, Sacubitril, Allisartan, Amlodipine
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Sacubitril/Allisartan and Amlodipine GroupDrug
Drug: Sacubitril/Allisartan and Amlodipine
Active Comparator: Amlodipine GroupDrug
Drug: Amlodipine
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Not described Receives: Drug: Experimental: Sacubitril/Allisartan and Amlodipine Group |
| Reference Group | Active comparator | Not described Receives: Drug: Active Comparator: Amlodipine Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The baseline change in mean seated systolic blood pressure (msSBP)
Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment
Measured: at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start28 Jun 2023
- Primary completion26 Aug 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Shenzhen Salubris Pharmaceuticals Co., Ltd.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704684
- Sponsor's protocol ID
- SAL0130A301
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sacubitril/Allisartan and Amlodipine in Patients With Essential Hypertension Uncontrolled With Amlodipine: A Phase III, Multicenter, Randomized, Double-blind, Parallel-controlled, 52-week Clinical Study
- ClinicalTrials.gov ID
- NCT07704684
- Acronym / sponsor ID
- SAL0130A301
- Conditions
- Essential Hypertension
- Keywords
- Hypertension, Sacubitril, Allisartan, Amlodipine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 15 Jul 2026 (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.
The main objective of the study will be to assess the efficacy and safety of Sacubitril/Allisartan (240mg) and Amlodipine (5mg) in patients with essential hypertension uncontrolled after 4-week treatment with Amlodipine (5mg).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: Experimental: Sacubitril/Allisartan and Amlodipine Group |
| Reference Group | Active comparator | Drug: Active Comparator: Amlodipine Group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients 18-75 years old.
- Confirmed diagnosis of essential hypertension.
- Patients who meet one of the following criteria when screening:
- At randomization, subjects must have msSBP ≥140 mmHg and <180 mmHg.
- Subjects voluntarily participate in the trial and sign the written informed consent form.
Key exclusion criteria (12 listed)
- Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg).
- History or confirmed diagnosis of secondary hypertension.
- Concomitant use of three or more types of antihypertensive agents.
- Personal history of angioedema induced by drugs or other causes.
- Clinically significant abnormal laboratory findings, including but not limited to: serum potassium >5.5 mmol/L or <3.5 mmol/L; serum ALT and/or AST >2.5 × upper limit of normal (ULN); serum creatinine >1.5 × ULN; any other clinically significant laboratory abnormality deemed by the investigator likely to confound efficacy and/or safety assessment of the study.
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 |
|---|---|---|
| Experimental: Sacubitril/Allisartan and Amlodipine GroupDrug: Sacubitril/Allisartan and Amlodipine | Drug | Test Group |
| Active Comparator: Amlodipine GroupDrug: Amlodipine | Drug | Reference Group |
Primary outcome
The baseline change in mean seated systolic blood pressure (msSBP)
Time frame: at 12 weeks
Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental: Sacubitril/Allisartan and Amlodipine Group and Active Comparator: Amlodipine Group in people with Essential Hypertension, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. 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 10 inclusion and 12 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: finished, as of the sponsor's last update on 15 Jul 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The baseline change in mean seated systolic blood pressure (msSBP) (time frame: at 12 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 15 Jul 2026.