Essential HypertensionPhase 3NCT06500689

To Assess Allisartan Isoproxil/Sustained-Release Indapamide in Patients With Essential Hypertension Uncontrolled With Allisartan Isoproxil

A Phase 3 study testing Allisartan Isoproxil/Sustained-Release Indapamide and Allisartan Isoproxil in people with Essential Hypertension, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 40 sites 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/sustained-release indapamide (240 mg/1.5 mg) in patients with mild to moderate essential hypertension uncontrolled after 4-week treatment with Allisartan Isoproxil (240 mg). 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?: Allisartan Isoproxil/Sustained-Release Indapamide and Allisartan Isoproxil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 366 participants
Where: 40 sitesChina
Study dates: 30 Dec 2021to 24 May 2024
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 with mild to moderate essential hypertension;
Patients who meet one of the following criteria when screening:
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 msDBP<110 mmHg;
Patients who had not received regular treatment with allisartan isoproxil (240 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 msSBP 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 msSBP of 140 mmHg≤ SBP <180 mmHg and DBP<110 mmHg, and the clinician determined that it was appropriate to switch to allisartan isoproxil (240 mg/day);
Patients who have been stably treated with allisartan isoproxil (240 mg/day) for at least 4 weeks with the msSBP of 140 mmHg≤ SBP <180 mmHg and DBP<110 mmHg.

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During randomization for the double-blind treatment period, msSBP should be 140 mmHg≤ SBP <180 mmHg and DBP<110 mmHg;
Participants enrolled in the ABPM study should have 24-hour mean ambulatory blood pressure ≥130/80 mmHg after 4 weeks of monotherapy treatment;
Patients who understand and sign the informed consent form.

Who cannot join

Patients with secondary hypertension;
Patients with msSBP ≥180 m mHg and/or msDBP≥110 mmHg, or withhypertensive emergency or hypertensive urgency.
Patients who have taken three or more antihypertensive drugs (including single-pill combination) simultaneously within one month prior to screening.
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 severe renal insufficiency (Cr>1.5 times the upper limit of normal).
Patients with hypokalemia or hyperkalemia.

Trial locations and contacts

40 sites in 1 country.

City, postcode or hospital

40 sites in 1 country

China40 sites

Aerospace Central Hospital
Beijing, Beijing Municipality
China-Japan Friendship Hospital
Beijing, Beijing Municipality
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui
Xiangya Second Hospital of Central South University
Changsha, Hunan
West China Hospital of Sichuan University
Chengdu, Sichuan
Chongqing University Affiliated Three Gorges Hospital
Chongqing, Chongqing Municipality
Daqing People's Hospital
Daqing, Heilongjiang
Shunde Hospital of Southern Medical University
Foshan, Guangdong
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Ganzhou People's Hospital
Ganzhou, Jiangxi
The First Affiliated Hospital of Gannan Medical College
Ganzhou, Jiangxi
Huai'an First People's Hospital
Huai'an, Jiangsu
Kaifeng Traditional Chinese Medicine Hospital
Kaifeng, Henan
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Gansu Provincial People's Hospital
Lanzhou, Gansu
Nanchong Central Hospital
Nanchong, Sichuan
Nanning First People's Hospital
Nanning, Guangxi
Li Huili Hospital of Ningbo Medical Center
Ningbo, Zhejiang
Pingxiang People's Hospital
Pingxiang, Jiangxi
Quzhou People's Hospital
Quzhou, Zhejiang
Hebei Provincial People's Hospital
Shijiazhuang, Hebei
Shijiazhuang People's Hospital
Shijiazhuang, Hebei
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei
Chinese Medicine Dongfeng General Hospital
Shiyan, Hubei
Suining Central Hospital
Suining, Sichuan
Suzhou Municipal Hospital
Suzhou, Jiangsu
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Tonghua Central Hospital
Tonghua, Jilin
Wenzhou Medical University Affiliated First Hospital
Wenzhou, Zhejiang
Wuhan First Hospital
Wuhan, Hubei
Wuhan Fourth Hospital
Wuhan, Hubei
Wuhan Sixth Hospital
Wuhan, Hubei
Shanxi Provincial People's Hospital
Xi’an, Shanxi
Xuancheng People's Hospital
Xuancheng, Anhui
Xuzhou Central Hospital
Xuzhou, Jiangsu
Yueyang Central Hospital
Yueyang, Hunan
Yueyang People's Hospital
Yueyang, Hunan
Guangdong Medical University Affiliated Hospital
Zhanjiang, Guangdong

Other trials in China

About this study

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

Read the detailed description

Allisartan isoproxil is a novel angiotensin receptor blocke available in China for over ten years and has the same active compound EXP3174 with losartan, while sustained-release indapamide is a long-standing thiazide-type diuretic. The novel single-pill combination of allisartan isoproxil and sustained-release indapamide exerts synergistic antihypertensive effects.

Conditions: Essential Hypertension
Being tested: Allisartan Isoproxil/Sustained-Release Indapamide, Allisartan Isoproxil
Keywords: Allisartan isoproxil, Indapamide, 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/Sustained-Release IndapamideDrug
Double-blind period (Week 1~Week 12): Allisartan Isoproxil/Sustained-Release Indapamide.
Open-label period (Week 13~Week 52): Allisartan Isoproxil/Sustained-Release Indapamide.
Allisartan IsoproxilDrug
Double-blind period (Week 1~Week 12): Allisartan Isoproxil.
Open-label period (Week 13~Week 52): Allisartan Isoproxil/Sustained-Release Indapamide.

Study groups in NCT06500689
Study group	Role	What they receive
Allisartan Isoproxil/Sustained-Release Indapamide Group	Experimental	Patients will be treated with one Allisartan Isoproxil/Sustained-Release Indapamide (240 mg/1.5 mg) tablet and one placebo of Allisartan Isoproxil during the double-blind period (Week 1~Week 12) and one Allisartan Isoproxil/Sustained-Release Indapamide (240 mg/1.5 mg) tablet during the open-label period (Week 13~Week 52) once daily. Receives: Drug: Allisartan Isoproxil/Sustained-Release Indapamide
Allisartan Isoproxil Group	Active comparator	Patients will be treated with one Allisartan Isoproxil (240 mg) and one placebo of Allisartan Isoproxil/Sustained-Release Indapamide (240 mg/1.5 mg) tablet during the double-blind period (Week 1~Week 12) and one Allisartan Isoproxil/Sustained-Release Indapamide (240 mg/1.5 mg) tablet during the open-label period (Week 13~Week 52) once daily. Receives: Drug: Allisartan Isoproxil

What is being measured

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

Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment
Measured: week 1, week 12.

Secondary outcomes (9)

Change from baseline in mean seated systolic blood pressure (msSBP) after 4 and 8 weeks of randomized, double-blind treatment
Measured: week 1, week 4, week 8.
Change from baseline in mean seated diastolic blood pressure (msDBP) after 4, 8, and 12 weeks of randomized, double-blind treatment
Measured: week 1, week 4, week 8, week 12.
The proportion of responders to antihypertensive treatment after 12 weeks of randomized, double-blind treatment. (Responders are the participants achieving SBP/DBP<140/90 mmHg or a reduction from baseline of >20 mmHg in msSBP and/or >10 mmHg in msDBP. )
Measured: week 1, week 12.
The proportion of patients meeting the mean sitting blood pressure target (SBP/DBP <140/90mmHg) after 4, 8, and 12 weeks of randomized, double-blind treatment
Measured: week 1, week 4, week 8, week 12.
The proportion of patients with the mean sitting blood pressure SBP/DBP <130/80mmHg) after 4, 8, and 12 weeks of randomized, double-blind treatment
Measured: week 1, week 4, week 8, week 12.
Change from baseline in msSBP after 20, 28, 40, and 52 weeks of treatment
Measured: week 1, week 20, week 28, week 40, week 52.
Change from baseline in msDBP after 20, 28, 40, and 52 weeks of treatment
Measured: week 1, week 20, week 28, week 40, week 52.
The proportion of patients meeting the mean sitting blood pressure target (SBP/DBP <140/90mmHg) after 52 weeks of treatment
Measured: week 1, week 52.
The proportion of patients with the mean sitting blood pressure SBP/DBP <130/80mmHg) after 52 weeks of treatment
Measured: week 1, week 52.

Timeline

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

30 Dec 202124 May 2024

First posted15 Jul 2024
Study start30 Dec 2021
Primary completion27 Nov 2023
Study completion24 May 2024

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: 366 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06500689
Sponsor's protocol ID: SAL0108A103
Status last verified: Jul 2024
First submitted: 8 Jul 2024
Last updated: 15 Jul 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

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 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Allisartan Isoproxil/Sustained-Release Indapamide in Patients With Essential Hypertension Uncontrolled With Allisartan Isoproxil: A Phase III, Multicenter, Randomized, Double-blind, Parallel-controlled, 52-week Clinical Study
ClinicalTrials.gov ID: NCT06500689
Acronym / sponsor ID: SAL0108A103
Conditions: Essential Hypertension
Keywords: Allisartan isoproxil, Indapamide, Essential hypertension, Systolic BP, Diastolic BP
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 366 participants (actual)
Lead sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Study start: 30 Dec 2021 (actual)
Primary completion: 27 Nov 2023 (actual)
Study completion: 24 May 2024 (actual)
First posted: 15 Jul 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

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
Allisartan Isoproxil/Sustained-Release Indapamide Group	Experimental	Drug: Allisartan Isoproxil/Sustained-Release IndapamidePatients will be treated with one Allisartan Isoproxil/Sustained-Release Indapamide (240 mg/1.5 mg) tablet and one placebo of Allisartan Isoproxil during the double-blind period (Week 1~Week 12) and one Allisartan Isoproxil/Sustained-Release Indapamide (240 mg/1.5 mg) tablet during the open-label period (Week 13~Week 52) once daily.
Allisartan Isoproxil Group	Active comparator	Drug: Allisartan IsoproxilPatients will be treated with one Allisartan Isoproxil (240 mg) and one placebo of Allisartan Isoproxil/Sustained-Release Indapamide (240 mg/1.5 mg) tablet during the double-blind period (Week 1~Week 12) and one Allisartan Isoproxil/Sustained-Release Indapamide (240 mg/1.5 mg) tablet during the open-label period (Week 13~Week 52) once daily.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Patients 18-75 years old with mild to moderate essential hypertension;
Patients who meet one of the following criteria when screening:
During randomization for the double-blind treatment period, msSBP should be 140 mmHg≤ SBP <180 mmHg and DBP<110 mmHg;
Participants enrolled in the ABPM study should have 24-hour mean ambulatory blood pressure ≥130/80 mmHg after 4 weeks of monotherapy treatment;
Patients who understand and sign the informed consent form.

Key exclusion criteria (8 listed)

Patients with secondary hypertension;
Patients with msSBP ≥180 m mHg and/or msDBP≥110 mmHg, or withhypertensive emergency or hypertensive urgency.
Patients who have taken three or more antihypertensive drugs (including single-pill combination) simultaneously within one month prior to screening.
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.

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/Sustained-Release IndapamideDouble-blind period (Week 1~Week 12): Allisartan Isoproxil/Sustained-Release Indapamide. Open-label period (Week 13~Week 52): Allisartan Isoproxil/Sustained-Release Indapamide.	Drug	Allisartan Isoproxil/Sustained-Release Indapamide Group
Allisartan IsoproxilDouble-blind period (Week 1~Week 12): Allisartan Isoproxil. Open-label period (Week 13~Week 52): Allisartan Isoproxil/Sustained-Release Indapamide.	Drug	Allisartan Isoproxil Group

Primary outcome

Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment
Time frame: week 1, week 12.

9 secondary outcomes

Change from baseline in mean seated systolic blood pressure (msSBP) after 4 and 8 weeks of randomized, double-blind treatment
Time frame: week 1, week 4, week 8.
Change from baseline in mean seated diastolic blood pressure (msDBP) after 4, 8, and 12 weeks of randomized, double-blind treatment
Time frame: week 1, week 4, week 8, week 12.
The proportion of responders to antihypertensive treatment after 12 weeks of randomized, double-blind treatment. (Responders are the participants achieving SBP/DBP<140/90 mmHg or a reduction from baseline of >20 mmHg in msSBP and/or >10 mmHg in msDBP. )
Time frame: week 1, week 12.
The proportion of patients meeting the mean sitting blood pressure target (SBP/DBP <140/90mmHg) after 4, 8, and 12 weeks of randomized, double-blind treatment
Time frame: week 1, week 4, week 8, week 12.
The proportion of patients with the mean sitting blood pressure SBP/DBP <130/80mmHg) after 4, 8, and 12 weeks of randomized, double-blind treatment
Time frame: week 1, week 4, week 8, week 12.
Change from baseline in msSBP after 20, 28, 40, and 52 weeks of treatment
Time frame: week 1, week 20, week 28, week 40, week 52.
Change from baseline in msDBP after 20, 28, 40, and 52 weeks of treatment
Time frame: week 1, week 20, week 28, week 40, week 52.
The proportion of patients meeting the mean sitting blood pressure target (SBP/DBP <140/90mmHg) after 52 weeks of treatment
Time frame: week 1, week 52.
The proportion of patients with the mean sitting blood pressure SBP/DBP <130/80mmHg) after 52 weeks of treatment
Time frame: week 1, week 52.

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 2024.

Related trials for Essential Hypertension

Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
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Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
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Recruiting
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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.

Jinxiu Lin, MD principal investigator

The First Affiliated Hospital of Fujian Medical University, Fuzhou 350212, China

40 sites 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 9 inclusion and 8 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 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites 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 seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment (time frame: week 1, 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 NCT06500689.

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 2024.