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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allisartan Isoproxil/Amlodipine group 1 | Experimental | 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. |
|
| Amlodipine group 1 | Active Comparator | 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. |
|
| Allisartan Isoproxil/Amlodipine group 2 | Experimental | 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 | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allisartan Isoproxil/Amlodipine group 1 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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, 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients meeting the mean sitting blood pressure target after 20 weeks of extended treatment | Sitting blood pressure target is SBP/DBP<140/90 mmHg | Week 36 |
| The proportion of patients meeting the mean sitting blood pressure target at the end of treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xinchun Yang, Ph.D | Beijing Chaoyang Hospital, Capital Medical University City:Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang Hospital, Capital Medical University | Beijing | Beijing Municipality | 100020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39821945 | Derived | Chi H, Zhang X, Ma S, Pan G, Lian X, Chen Y, Pei H, Liu Z, Lin X. Efficacy and Safety of Allisartan Isoproxil/Amlodipine in Patients With Essential Hypertension Uncontrolled by Amlodipine: A Phase III, Multicenter, Double-Blind, Parallel-Group, Randomized Controlled Trial. J Clin Hypertens (Greenwich). 2025 Jan;27(1):e14955. doi: 10.1111/jch.14955. |
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Double-blind treatment (Week 4~Week 16):
Open-label period(Week 16~ Week 56):
|
|
| Amlodipine group 1 | Drug | 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. |
|
| Allisartan Isoproxil/Amlodipine group 2 | Drug | 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. |
|
| Allisartan Isoproxil group 2 | Drug | 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. |
|
Twenty-four hour mean msSBP will be performed at baseline and week 4, week 8 of double-blind treatment |
| 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 | 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 | Week 4, week 8, week 12 |
Sitting blood pressure target is SBP/DBP<140/90 mmHg |
| Week 56 |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C587132 | allisartan isoproxil |
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