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

Phase 3

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: Allisartan Isoproxil/Amlodipine group 1; Drug: Allisartan Isoproxil/Amlodipine group 2; Drug: Allisartan Isoproxil group 2; Drug: Amlodipine group 1

• Registration Number: NCT06465264
• Lead Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.

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).

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.

Study Timeline

• Study Start: 2021-04-29
• Primary Completion: 2022-08-16
• Study Completion: 2023-02-24
• Status Verified: 2024-06
• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-18
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 499

Inclusion Criteria

• 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;

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allisartan Isoproxil/Amlodipine group 1	Allisartan Isoproxil/Amlodipine group 1	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.
Allisartan Isoproxil/Amlodipine group 2	Allisartan Isoproxil/Amlodipine group 2	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.
Allisartan Isoproxil group 2	Allisartan Isoproxil group 2	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.
Amlodipine group 1	Amlodipine group 1	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in mean sitting diastolic blood pressure after 12 weeks of randomized, double-blind treatment	Baseline, week 12	Twenty-four hour mean msDBP will be performed at baseline and week 12 of double-blind treatment
The proportion of responders to antihypertensive treatment after 12 weeks of randomized, double-blind treatment	Week 12	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
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	Sitting blood pressure target is SBP/DBP\<140/90 mmHg
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	Twenty-four hour mean msSBP will be performed at baseline and week 4, week 8 of double-blind treatment

Trial Locations

Locations (1)

Beijing Chaoyang Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China