Efficacy and Safety of Allisartan Isoproxil/Amlodipine Tablets in Patients With Essential Hypertension Uncontrolled With Amlodipine or Allisartan Isoproxil: A Phase III, Multicenter, Randomized, Double-blind, Parallel-controlled, 52-week Clinical Study

SAL0107A103

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) .

2021-04-29

2022-08-16

2023-02-24

Completed

Early phase I

499

Inclusion Criteria: * Patients of 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 prior to first visit) must have an offcie 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 Amlodi-pine 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 into the ambulatory blood pressure monitoring (ABPM) study should have 24-hour mean ambulatory blood pressure ≥130/80 mmHg after 4 weeks of mon-otherapy treatment; Exclusion Criteria: * Patients with secondary hypertension; * msSBP ≥180 mmHg and/or msDBP≥110 mmHg, or with hypertensive emergency or hypertensive urgency. * 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. * History of severe cerebrovascular diseases (such as hypertensive encephalopathy, cerebrovascular injury, stroke, transient ischemic attack) in the past 6 months. * Presence of aortic aneurysm, aortic dissection or dissecting aneurysm. * Presence of renal artery stenosis or severe renal insufficiency (Cr\>1.5 times the upper limit of normal) . * blood potassium \>5.5 mmol/L

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2024-06-18