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

NCT06465264 | Completed Phase 3

• 1 other identifier: SAL0107A103
• Study Type: interventional
• Target: 499
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Essential Hypertension

Keywords

Allisartan Isoproxil; Amlodipine; Essential hypertension; Systolic BP; Diastolic BP

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, week 12

Secondary Outcomes (4)

• Change from baseline in mean sitting diastolic blood pressure after 12 weeks of randomized, double-blind treatment

  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

  Baseline, week 4, week 8

• The proportion of responders to antihypertensive treatment after 12 weeks of randomized, double-blind treatment

  Week 12

• The proportion of patients meeting the mean sitting blood pressure target after 4, 8, and 12 weeks of randomized, double-blind treatment

  Week 4, week 8, week 12

Other Outcomes (2)

• The proportion of patients meeting the mean sitting blood pressure target after 20 weeks of extended treatment

  Week 36

• The proportion of patients meeting the mean sitting blood pressure target at the end of treatment

  Week 56

Study Arms (4)

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.

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.

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.

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.

Drug: Allisartan Isoproxil group 2

Interventions

Allisartan Isoproxil/Amlodipine group 1 DRUG

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.

Allisartan Isoproxil/Amlodipine group 1

Amlodipine group 1 DRUG

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.

Amlodipine group 1

Allisartan Isoproxil/Amlodipine group 2 DRUG

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/Amlodipine group 2

Allisartan Isoproxil group 2 DRUG

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.

Allisartan Isoproxil group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

Related Publications (1)

• 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.

  PMID: 39821945 DERIVED

MeSH Terms

Conditions

Essential Hypertension

Interventions

allisartan isoproxil

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xinchun Yang, Ph.D

  Beijing Chaoyang Hospital, Capital Medical University City:Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind treatment (Week 4\~Week 16): Open-label period(Week 16\~ Week 56):
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: April 29, 2021
• Primary Completion: August 16, 2022
• Study Completion: February 24, 2023
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

CN (1)