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

NCT ID: NCT06500689

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-30
• Study Completion Date: 2024-05-24

Brief 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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Allisartan Isoproxil/Sustained-Release Indapamide Group

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.

Group Type: EXPERIMENTAL

Allisartan Isoproxil/Sustained-Release Indapamide

Intervention Type: DRUG

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 Isoproxil Group

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.

Group Type: ACTIVE_COMPARATOR

Allisartan Isoproxil

Intervention Type: DRUG

Double-blind period (Week 1~Week 12): Allisartan Isoproxil.

Open-label period (Week 13~Week 52): Allisartan Isoproxil/Sustained-Release Indapamide.

Interventions

Allisartan Isoproxil/Sustained-Release Indapamide

Double-blind period (Week 1~Week 12): Allisartan Isoproxil/Sustained-Release Indapamide.

Open-label period (Week 13~Week 52): Allisartan Isoproxil/Sustained-Release Indapamide.

Intervention Type: DRUG

Allisartan Isoproxil

Double-blind period (Week 1~Week 12): Allisartan Isoproxil.

Open-label period (Week 13~Week 52): Allisartan Isoproxil/Sustained-Release Indapamide.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients 18-75 years old with mild to moderate essential hypertension;

2. Patients who meet one of the following criteria when screening:

1. 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;

2. 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;

3. 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);

4. 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.

3. During randomization for the double-blind treatment period, msSBP should be 140 mmHg≤ SBP <180 mmHg and DBP<110 mmHg;

4. Participants enrolled in the ABPM study should have 24-hour mean ambulatory blood pressure ≥130/80 mmHg after 4 weeks of monotherapy treatment;

5. Patients who understand and sign the informed consent form.

Exclusion Criteria

1. Patients with secondary hypertension;

2. Patients with msSBP ≥180 m mHg and/or msDBP≥110 mmHg, or withhypertensive emergency or hypertensive urgency.

3. Patients who have taken three or more antihypertensive drugs (including single-pill combination) simultaneously within one month prior to screening.

4. 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.

5. Patients with history of severe cerebrovascular diseases (such as hypertensive encephalopathy, cerebrovascular injury, stroke, transient ischemic attack) in the past 6 months.

6. Patients with aortic aneurysm, aortic dissection, or dissecting aneurysm.

7. Patients with severe renal insufficiency (Cr>1.5 times the upper limit of normal).

8. Patients with hypokalemia or hyperkalemia.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Salubris Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinxiu Lin, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Xuancheng People's Hospital

Xuancheng, Anhui, China

Aerospace Central Hospital

Beijing, Beijing Municipality, China

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Chongqing University Affiliated Three Gorges Hospital

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Gansu Provincial People's Hospital

Lanzhou, Gansu, China

Shunde Hospital of Southern Medical University

Foshan, Guangdong, China

Guangdong Medical University Affiliated Hospital

Zhanjiang, Guangdong, China

Nanning First People's Hospital

Nanning, Guangxi, China

Hebei Provincial People's Hospital

Shijiazhuang, Hebei, China

Shijiazhuang People's Hospital

Shijiazhuang, Hebei, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Daqing People's Hospital

Daqing, Heilongjiang, China

Kaifeng Traditional Chinese Medicine Hospital

Kaifeng, Henan, China

Chinese Medicine Dongfeng General Hospital

Shiyan, Hubei, China

Wuhan First Hospital

Wuhan, Hubei, China

Wuhan Fourth Hospital

Wuhan, Hubei, China

Wuhan Sixth Hospital

Wuhan, Hubei, China

Xiangya Second Hospital of Central South University

Changsha, Hunan, China

Yueyang Central Hospital

Yueyang, Hunan, China

Yueyang People's Hospital

Yueyang, Hunan, China

Huai'an First People's Hospital

Huai'an, Jiangsu, China

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Ganzhou People's Hospital

Ganzhou, Jiangxi, China

The First Affiliated Hospital of Gannan Medical College

Ganzhou, Jiangxi, China

Pingxiang People's Hospital

Pingxiang, Jiangxi, China

Tonghua Central Hospital

Tonghua, Jilin, China

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Shanxi Provincial People's Hospital

Xi’an, Shanxi, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Nanchong Central Hospital

Nanchong, Sichuan, China

Suining Central Hospital

Suining, Sichuan, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Li Huili Hospital of Ningbo Medical Center

Ningbo, Zhejiang, China

Quzhou People's Hospital

Quzhou, Zhejiang, China

Wenzhou Medical University Affiliated First Hospital

Wenzhou, Zhejiang, China

Countries

China

Other Identifiers

SAL0108A103

Identifier Type: -

Identifier Source: org_study_id