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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
499
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.
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.
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.
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
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
Time frame: Baseline, week 12
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
Time frame: 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
Twenty-four hour mean msSBP will be performed at baseline and week 4, week 8 of double-blind treatment
Time frame: Baseline, week 4, week 8
The proportion of responders to antihypertensive treatment after 12 weeks of randomized, double-blind treatment
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
Time frame: Week 12
The 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 is SBP/DBP\<140/90 mmHg
Time frame: Week 4, week 8, week 12
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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.