Essential HypertensionPhase 3NCT06465264

To Assess Allisartan Isoproxil/Amlodipine in Patients With Essential Hypertension Uncontrolled With Amlodipine or Allisartan Isoproxil

A Phase 3 study testing Allisartan Isoproxil/Amlodipine group 1, Amlodipine group 1 and Allisartan Isoproxil/Amlodipine group 2 in people with Essential Hypertension, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main objective of the study will be to assess the efficacy and safety of Allisartan Isoproxil/Amlodipine (240 mg/5 mg) in patients with mild to moderate essential hypertension uncontrolled after 4-week treatment with Amlodipine besylate（5 mg) or Allisartan Isoproxil (240 mg). Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Essential Hypertension
What is being tested?: Allisartan Isoproxil/Amlodipine group 1, Amlodipine group 1 and Allisartan Isoproxil/Amlodipine group 2
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 499 participants
Where: 1 siteChina
Study dates: 29 Apr 2021to 24 Feb 2023
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients 18-70 years old with mild to moderate essential hypertension;
Untreated patients (either newly diagnosed essential hypertension or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 2 weeks before the first visit) must have an office msSBP ≥ 150 mmHg and < 180 mmHg and DBP<110 mmHg;
Patients who had not received regular treatment with Amlodipine Besylate (5 mg/day) (less than 4 weeks of medication intake or a history of missing doses for 5 or more days within the 4 weeks before screening) with the mean sitting blood pressure of 140 mmHg≤ SBP <180 mmHg and DBP<110 mmHg;
Patients currently receiving other antihypertensive agents (non-study medications for at least 2 weeks prior to screening) with the mean sitting blood pressure of 140 mmHg≤ SBP <180 mmHg and DBP<110 mmHg, and the clinician determined that it was appropriate to switch to Amlodipine Besylate (5 mg/day);
Patients who have been stably treated with Amlodipine Besylate (5 mg/day) for at least 4 weeks with the mean sitting blood pressure of 140 mmHg≤ SBP <180 mmHg and DBP<110 mmHg. During randomization for the double-blind treatment period, mean sitting blood pressure should be 140 mmHg≤ SBP <180 mmHg and DBP<110 mmHg;
Participants enrolled in the ambulatory blood pressure monitoring (ABPM) study should have 24-hour mean ambulatory blood pressure ≥130/80 mmHg after 4 weeks of monotherapy treatment;

Who cannot join

Patients with secondary hypertension;
Patients with msSBP ≥180 mmHg and/or msDBP≥110 mmHg, or with hypertensive emergency or hypertensive urgency.
Patients with history of heart failure (New York Heart Association (NYHA) Functional Classification class III and IV), acute coronary syndrome, percutaneous coronary intervention, or other serious heart diseases (such as cardiogenic shock, moderate or severe heart valvular disorders, atrioventricular block second or third degree, bradycardia (with a heart rate <50 beats per minute), severe arrhythmias) in the past 6 months.
Patients with history of severe cerebrovascular diseases (such as hypertensive encephalopathy, cerebrovascular injury, stroke, transient ischemic attack) in the past 6 months.
Patients with aortic aneurysm, aortic dissection, or dissecting aneurysm.
Patients with renal artery stenosis or severe renal insufficiency (Cr>1.5 times the upper limit of normal).
Patients with blood potassium >5.5 mmol/L.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020

Other trials in China

About this study

Official title: Efficacy and Safety of Allisartan Isoproxil/Amlodipine in Patients With Essential Hypertension Uncontrolled With Amlodipine or Allisartan Isoproxil: A Phase III, Multicenter, Randomized, Double-blind, Parallel-controlled, 52-week Clinical Study

Read the detailed description

Amlodipine belongs to the calcium channel blocker (CCB) class of drugs, which acts as an antihypertensive agent mainly via blocking calcium channels on the vascular smooth muscle cells to dilate blood vessels.

Allisartan Isoproxil belongs to the ARB class of drugs, which can effectively exert antihypertensive effects.

The combination of dihydropyridine CCBs and ARBs exerts synergistic antihypertensive effects.

Conditions: Essential Hypertension
Being tested: Allisartan Isoproxil/Amlodipine group 1, Amlodipine group 1, Allisartan Isoproxil/Amlodipine group 2, Allisartan Isoproxil group 2
Keywords: Allisartan Isoproxil, Amlodipine, Essential hypertension, Systolic BP, Diastolic BP
Medical subject headings: Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Allisartan Isoproxil/Amlodipine group 1Drug
One Allisartan Isoproxil/Amlodipine (240 mg/5 mg) tablet and one placebo of Amlodipine during the double-blind period (Week 4~Week 16).
One Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16~ Week 56) once daily.
Amlodipine group 1Drug
One Amlodipine (5 mg) tablet and one placebo of Allisartan Isoproxil/Amlodipine during the double-blind period (Week 4~Week 16).
One Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16~ Week 56) once daily.
Allisartan Isoproxil/Amlodipine group 2Drug
One Allisartan Isoproxil/Amlodipine (240 mg/5 mg) tablet and one placebo of Allisartan Isoproxil (240 mg) during the double-blind period (Week 4~Week 16).
One Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16~ Week 56) once daily.
Allisartan Isoproxil group 2Drug
One Allisartan Isoproxil (240 mg) and one placebo of Allisartan Isoproxil/Amlodipine (240 mg/5 mg) during the double-blind period (Week 4~Week 16).
One Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16~ Week 56) once daily.

Study groups in NCT06465264
Study group	Role	What they receive
Allisartan Isoproxil/Amlodipine group 1	Experimental	Patients will be treated with one Allisartan Isoproxil/Amlodipine (240 mg/5 mg) tablet and one placebo of Amlodipine during the double-blind period (Week 4~Week 16) and one Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16~ Week 56) once daily. Receives: Drug: Allisartan Isoproxil/Amlodipine group 1
Amlodipine group 1	Active comparator	Patients will be treated with one Amlodipine (5 mg) tablet and one placebo of Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the double-blind period (Week 4~Week 16) and one Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16~ Week 56) once daily. Receives: Drug: Amlodipine group 1
Allisartan Isoproxil/Amlodipine group 2	Experimental	Patients will be treated with one Allisartan Isoproxil/Amlodipine (240 mg/5 mg) tablet and one placebo of Allisartan Isoproxil tablet during the double-blind period (Week 4~Week 16) and one Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16~ Week 56) once daily. Receives: Drug: Allisartan Isoproxil/Amlodipine group 2
Allisartan Isoproxil group 2	Active comparator	Patients will be treated with one Allisartan Isoproxil (240 mg) and one placebo of Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the double-blind period (Week 4~Week 16) and one Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16~ Week 56) once daily. Receives: Drug: Allisartan Isoproxil group 2

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in mean sitting systolic blood pressure after 12 weeks of randomized, double-blind treatment
Twenty-four hour mean msSBP will be performed at baseline and week 12 of double-blind treatment
Measured: Baseline, week 12

Secondary outcomes (4)

Change from baseline in mean sitting diastolic blood pressure after 12 weeks of randomized, double-blind treatment
Twenty-four hour mean msDBP will be performed at baseline and week 12 of double-blind treatment
Measured: Baseline, week 12
Change from baseline in mean sitting systolic blood pressure and mean sitting diastolic blood pressure after 4 and 8 weeks of randomized, double-blind treatment
Twenty-four hour mean msSBP will be performed at baseline and week 4, week 8 of double-blind treatment
Measured: Baseline, week 4, week 8
The proportion of responders to antihypertensive treatment after 12 weeks of randomized, double-blind treatment
Responders is the ratio of the number of participants achieving SBP/DBP<140/90 mmHg or a reduction from baseline of >20 mmHg in mean systolic blood pressure and or >10 mmHg in mean diastolic blood pressure to the total number of participants in each group
Measured: Week 12
The proportion of patients meeting the mean sitting blood pressure target after 4, 8, and 12 weeks of randomized, double-blind treatment
Sitting blood pressure target is SBP/DBP<140/90 mmHg
Measured: Week 4, week 8, week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Apr 202124 Feb 2023

First posted18 Jun 2024
Study start29 Apr 2021
Primary completion16 Aug 2022
Study completion24 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: 499 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06465264
Sponsor's protocol ID: SAL0107A103
Status last verified: Jun 2024
First submitted: 13 Jun 2024
Last updated: 28 Jun 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Chi H, Zhang X, Ma S, Pan G, Lian X, Chen Y, Pei H, Liu Z, Lin X. Efficacy and Safety of Allisartan Isoproxil/Amlodipine in Patients With Essential Hypertension Uncontrolled by Amlodipine: A Phase III, Multicenter, Double-Blind, Parallel-Group, Randomized Controlled Trial. J Clin Hypertens (Greenwich). 2025 Jan;27(1):e14955. doi: 10.1111/jch.14955.
PubMed 39821945

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Essential Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Allisartan Isoproxil/Amlodipine in Patients With Essential Hypertension Uncontrolled With Amlodipine or Allisartan Isoproxil: A Phase III, Multicenter, Randomized, Double-blind, Parallel-controlled, 52-week Clinical Study
ClinicalTrials.gov ID: NCT06465264
Acronym / sponsor ID: SAL0107A103
Conditions: Essential Hypertension
Keywords: Allisartan Isoproxil, Amlodipine, Essential hypertension, Systolic BP, Diastolic BP
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 499 participants (actual)
Lead sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Study start: 29 Apr 2021 (actual)
Primary completion: 16 Aug 2022 (actual)
Study completion: 24 Feb 2023 (actual)
First posted: 18 Jun 2024 (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.

Detailed description

Allisartan Isoproxil belongs to the ARB class of drugs, which can effectively exert antihypertensive effects.

The combination of dihydropyridine CCBs and ARBs exerts synergistic antihypertensive effects.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Allisartan Isoproxil/Amlodipine group 1	Experimental	Drug: Allisartan Isoproxil/Amlodipine group 1Patients will be treated with one Allisartan Isoproxil/Amlodipine (240 mg/5 mg) tablet and one placebo of Amlodipine during the double-blind period (Week 4~Week 16) and one Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16~ Week 56) once daily.
Amlodipine group 1	Active comparator	Drug: Amlodipine group 1Patients will be treated with one Amlodipine (5 mg) tablet and one placebo of Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the double-blind period (Week 4~Week 16) and one Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16~ Week 56) once daily.
Allisartan Isoproxil/Amlodipine group 2	Experimental	Drug: Allisartan Isoproxil/Amlodipine group 2Patients will be treated with one Allisartan Isoproxil/Amlodipine (240 mg/5 mg) tablet and one placebo of Allisartan Isoproxil tablet during the double-blind period (Week 4~Week 16) and one Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16~ Week 56) once daily.
Allisartan Isoproxil group 2	Active comparator	Drug: Allisartan Isoproxil group 2Patients will be treated with one Allisartan Isoproxil (240 mg) and one placebo of Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the double-blind period (Week 4~Week 16) and one Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16~ Week 56) once daily.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients 18-70 years old with mild to moderate essential hypertension;
Untreated patients (either newly diagnosed essential hypertension or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 2 weeks before the first visit) must have an office msSBP ≥ 150 mmHg and < 180 mmHg and DBP<110 mmHg;
Patients who had not received regular treatment with Amlodipine Besylate (5 mg/day) (less than 4 weeks of medication intake or a history of missing doses for 5 or more days within the 4 weeks before screening) with the mean sitting blood pressure of 140 mmHg≤ SBP <180 mmHg and DBP<110 mmHg;
Patients currently receiving other antihypertensive agents (non-study medications for at least 2 weeks prior to screening) with the mean sitting blood pressure of 140 mmHg≤ SBP <180 mmHg and DBP<110 mmHg, and the clinician determined that it was appropriate to switch to Amlodipine Besylate (5 mg/day);
Patients who have been stably treated with Amlodipine Besylate (5 mg/day) for at least 4 weeks with the mean sitting blood pressure of 140 mmHg≤ SBP <180 mmHg and DBP<110 mmHg. During randomization for the double-blind treatment period, mean sitting blood pressure should be 140 mmHg≤ SBP <180 mmHg and DBP<110 mmHg;

Key exclusion criteria (7 listed)

Patients with secondary hypertension;
Patients with msSBP ≥180 mmHg and/or msDBP≥110 mmHg, or with hypertensive emergency or hypertensive urgency.
Patients with history of heart failure (New York Heart Association (NYHA) Functional Classification class III and IV), acute coronary syndrome, percutaneous coronary intervention, or other serious heart diseases (such as cardiogenic shock, moderate or severe heart valvular disorders, atrioventricular block second or third degree, bradycardia (with a heart rate <50 beats per minute), severe arrhythmias) in the past 6 months.
Patients with history of severe cerebrovascular diseases (such as hypertensive encephalopathy, cerebrovascular injury, stroke, transient ischemic attack) in the past 6 months.
Patients with aortic aneurysm, aortic dissection, or dissecting aneurysm.

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
Allisartan Isoproxil/Amlodipine group 1One Allisartan Isoproxil/Amlodipine (240 mg/5 mg) tablet and one placebo of Amlodipine during the double-blind period (Week 4~Week 16). One Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16~ Week 56) once daily.	Drug	Allisartan Isoproxil/Amlodipine group 1
Amlodipine group 1One Amlodipine (5 mg) tablet and one placebo of Allisartan Isoproxil/Amlodipine during the double-blind period (Week 4~Week 16). One Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16~ Week 56) once daily.	Drug	Amlodipine group 1
Allisartan Isoproxil/Amlodipine group 2One Allisartan Isoproxil/Amlodipine (240 mg/5 mg) tablet and one placebo of Allisartan Isoproxil (240 mg) during the double-blind period (Week 4~Week 16). One Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16~ Week 56) once daily.	Drug	Allisartan Isoproxil/Amlodipine group 2
Allisartan Isoproxil group 2One Allisartan Isoproxil (240 mg) and one placebo of Allisartan Isoproxil/Amlodipine (240 mg/5 mg) during the double-blind period (Week 4~Week 16). One Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16~ Week 56) once daily.	Drug	Allisartan Isoproxil group 2

Primary outcome

Change from baseline in mean sitting systolic blood pressure after 12 weeks of randomized, double-blind treatment
Time frame: Baseline, week 12
Twenty-four hour mean msSBP will be performed at baseline and week 12 of double-blind treatment

4 secondary outcomes

Change from baseline in mean sitting diastolic blood pressure after 12 weeks of randomized, double-blind treatment
Time frame: Baseline, week 12
Change from baseline in mean sitting systolic blood pressure and mean sitting diastolic blood pressure after 4 and 8 weeks of randomized, double-blind treatment
Time frame: Baseline, week 4, week 8
The proportion of responders to antihypertensive treatment after 12 weeks of randomized, double-blind treatment
Time frame: Week 12
The proportion of patients meeting the mean sitting blood pressure target after 4, 8, and 12 weeks of randomized, double-blind treatment
Time frame: Week 4, week 8, week 12

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 28 Jun 2024.
Derived from this study: PubMed 39821945Chi H, Zhang X, Ma S, Pan G, Lian X, Chen Y, Pei H, Liu Z, Lin X. Efficacy and Safety of Allisartan Isoproxil/Amlodipine in Patients With Essential Hypertension Uncontrolled by Amlodipine: A Phase III, Multicenter, Double-Blind, Parallel-Group, Randomized Controlled Trial. J Clin Hypertens (Greenwich). 2025 Jan;27(1):e14955. doi: 10.1111/jch.14955.

Related trials for Essential Hypertension

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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.

Xinchun Yang, Ph.D principal investigator

Beijing Chaoyang Hospital, Capital Medical University City:Beijing

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 7 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 28 Jun 2024. 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?

Change from baseline in mean sitting systolic blood pressure after 12 weeks of randomized, double-blind treatment (time frame: Baseline, week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06465264, which also lists 1 linked publication.

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 28 Jun 2024.