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

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06465264
• Other study ID #: SAL0107A103
• Status: Completed
• Phase: Phase 3
• Start date: April 29, 2021
• Est. completion date: February 24, 2023

Study information

• Verified date: June 2024
• Source: Shenzhen Salubris Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

Description:

Amlodipine belongs to the calcium channel blocker (CCB) class of drugs, which acts as 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 effect. The combination of dihydropyridine CCBs and ARBs exerts synergistic antihypertensive effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 499
• Est. completion date: February 24, 2023
• Est. primary completion date: August 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 33 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Allisartan Isoproxil/Amlodipine group1
Allisartan Isoproxil/Amlodipine (240 mg /5 mg) tablet and one placebo of Amlodipine during double-blind period (Week 4~Week 16) . Allisartan Isoproxil/Amlodipine(240 mg /5 mg) tablet during open-lable period(Week 16~ Week 56) once daily.
• Amlodipine group1
Amlodipine (5 mg) tablet and one placebo of Allisartan Isoproxil/Amlodipineduring double-blind period (Week 4~Week 16). Allisartan Isoproxil/Amlodipine(240 mg /5 mg) tablet during open-lable period(Week 16~ Week 56) once daily.
• Allisartan Isoproxil/Amlodipine group2
Allisartan Isoproxil/Amlodipine (240 mg /5 mg) tablet and one placebo of Allisartan Isoproxil (240 mg) during double-blind period (Week 4~Week 16). Allisartan Isoproxil/Amlodipine(240 mg /5 mg) tablet during open-lable period(Week 16~ Week 56) once daily
• Allisartan Isoproxil group2
Allisartan Isoproxil (240 mg) and one placebo of Allisartan Isoproxil/Amlodipine during double-blind period (Week 4~Week 16). Allisartan Isoproxil/Amlodipine(240 mg /5 mg) tablet during open-lable period(Week 16~ Week 56) once daily

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Salubris Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of patients meeting the mean sitting blood pressure target after 20 weeks of extended treatment	Sitting blood pressure target defined as SBP/DBP<140/90 mmHg.	Baseline, 52 weeks
Other	Proportion of patients meeting the mean sitting blood pressure target at the end of treatment	Sitting blood pressure target defined as SBP/DBP<140/90 mmHg.	Baseline, 52 weeks
Primary	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, 12 weeks
Secondary	Change from baseline in mean sitting diastolic blood pressure after 12 weeks of randomized double-blind treatment	Twenty-four hour mean msDBP will be performed at baseline and week 12 of double-blind treatment	Baseline, 12 weeks
Secondary	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	Twenty-four hour mean msSBP will be performed at baseline and week 4/week8 of double-blind treatment	Baseline, 12 weeks
Secondary	Proportion of responders to antihypertensive treatment after 12 weeks of randomized double-blind treatment	Responders defined as 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.	Baseline, 12 weeks
Secondary	Proportion of patients meeting the mean sitting blood pressure target after 4, 8, and 12 weeks of randomized double-blind treatment	Sitting blood pressure target defined as SBP/DBP<140/90 mmHg.	Baseline, 12 weeks