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

NCT06500689 | Completed Phase 3

• 1 other identifier: SAL0108A103
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 40

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).

Conditions

Essential Hypertension

Keywords

Allisartan isoproxil; Indapamide; Essential hypertension; Systolic BP; Diastolic BP

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment

  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

  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

  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. )

  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

  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

  week 1, week 4, week 8, week 12.

Other Outcomes (3)

• Change from baseline in 24-hour mean systolic and diastolic blood pressure during ambulatory blood pressure monitoring (ABPM) after 12 weeks of randomized, double-blind treatment

  week 1, week 12.

• Change from baseline in daytime mean systolic and diastolic blood pressure during ambulatory blood pressure monitoring (ABPM) after 12 weeks of randomized, double-blind treatment

  week 1, week 12.

• Change from baseline in nighttime mean systolic and diastolic blood pressure during ambulatory blood pressure monitoring (ABPM) after 12 weeks of randomized, double-blind treatment

  week 1, week 12.

Study Arms (2)

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.

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.

Drug: Allisartan Isoproxil

Interventions

Allisartan Isoproxil/Sustained-Release Indapamide 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/Sustained-Release Indapamide Group

Allisartan Isoproxil DRUG

Double-blind period (Week 1\~Week 12): Allisartan Isoproxil. Open-label period (Week 13\~Week 52): Allisartan Isoproxil/Sustained-Release Indapamide.

Allisartan Isoproxil Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (40)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Location

Xuancheng People's Hospital

Xuancheng, Anhui, China

Location

Aerospace Central Hospital

Beijing, Beijing Municipality, China

Location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Location

Chongqing University Affiliated Three Gorges Hospital

Chongqing, Chongqing Municipality, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

Gansu Provincial People's Hospital

Lanzhou, Gansu, China

Location

Shunde Hospital of Southern Medical University

Foshan, Guangdong, China

Location

Guangdong Medical University Affiliated Hospital

Zhanjiang, Guangdong, China

Location

Nanning First People's Hospital

Nanning, Guangxi, China

Location

Hebei Provincial People's Hospital

Shijiazhuang, Hebei, China

Location

Shijiazhuang People's Hospital

Shijiazhuang, Hebei, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Daqing People's Hospital

Daqing, Heilongjiang, China

Location

Kaifeng Traditional Chinese Medicine Hospital

Kaifeng, Henan, China

Location

Chinese Medicine Dongfeng General Hospital

Shiyan, Hubei, China

Location

Wuhan First Hospital

Wuhan, Hubei, China

Location

Wuhan Fourth Hospital

Wuhan, Hubei, China

Location

Wuhan Sixth Hospital

Wuhan, Hubei, China

Location

Xiangya Second Hospital of Central South University

Changsha, Hunan, China

Location

Yueyang Central Hospital

Yueyang, Hunan, China

Location

Yueyang People's Hospital

Yueyang, Hunan, China

Location

Huai'an First People's Hospital

Huai'an, Jiangsu, China

Location

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Location

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Location

Ganzhou People's Hospital

Ganzhou, Jiangxi, China

Location

The First Affiliated Hospital of Gannan Medical College

Ganzhou, Jiangxi, China

Location

Pingxiang People's Hospital

Pingxiang, Jiangxi, China

Location

Tonghua Central Hospital

Tonghua, Jilin, China

Location

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Shanxi Provincial People's Hospital

Xi’an, Shanxi, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

Nanchong Central Hospital

Nanchong, Sichuan, China

Location

Suining Central Hospital

Suining, Sichuan, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Location

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

Li Huili Hospital of Ningbo Medical Center

Ningbo, Zhejiang, China

Location

Quzhou People's Hospital

Quzhou, Zhejiang, China

Location

Wenzhou Medical University Affiliated First Hospital

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

allisartan isoproxil

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jinxiu Lin, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: December 30, 2021
• Primary Completion: November 27, 2023
• Study Completion: May 24, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

CN (40)