Clinical trial NCT06465264: To Assess Allisartan Isoproxil/Amlodipine in Patients With Essential Hypertension Uncontrolled With Amlodipine or Allisartan Isoproxil
Official title: Efficacy and Safety of Allisartan Isoproxil/Amlodipine in Patients With Essential Hypertension Uncontrolled With Amlodipine or Allisartan Isoproxil: A Phase III, Multicenter, Randomized, Double-blind, Parallel-controlled, 52-week Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Keywords: Allisartan Isoproxil
Amlodipine
Essential hypertension
Systolic BP
Diastolic BP
Lead sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-18
Enrollment: 499
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

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.

Primary outcomes:
measure: Change from baseline in mean sitting systolic blood pressure after 12 weeks of randomized, double-blind treatment
timeFrame: Baseline, week 12
Secondary outcomes:
measure: Change from baseline in mean sitting diastolic blood pressure after 12 weeks of randomized, double-blind treatment
timeFrame: Baseline, week 12
measure: 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
timeFrame: Baseline, week 4, week 8
measure: The proportion of responders to antihypertensive treatment after 12 weeks of randomized, double-blind treatment
timeFrame: Week 12
measure: The proportion of patients meeting the mean sitting blood pressure target after 4, 8, and 12 weeks of randomized, double-blind treatment
timeFrame: Week 4, week 8, week 12
Other outcomes:
measure: The proportion of patients meeting the mean sitting blood pressure target after 20 weeks of extended treatment
timeFrame: Week 36
measure: The proportion of patients meeting the mean sitting blood pressure target at the end of treatment
timeFrame: Week 56
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Chaoyang Hospital, Capital Medical University City:Beijing
name: Xinchun Yang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: