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The main objective of the study will be to assess the efficacy and safety of Allisartan Isoproxil/sustained-release indapamide (240 mg/1.5 mg) in patients with mild to moderate essential hypertension uncontrolled after 4-week treatment with Allisartan Isoproxil (240 mg).
Allisartan isoproxil is a novel angiotensin receptor blocke available in China for over ten years and has the same active compound EXP3174 with losartan, while sustained-release indapamide is a long-standing thiazide-type diuretic. The novel single-pill combination of allisartan isoproxil and sustained-release indapamide exerts synergistic antihypertensive effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allisartan Isoproxil/Sustained-Release Indapamide Group | Experimental | Patients will be treated with one Allisartan Isoproxil/Sustained-Release Indapamide (240 mg/1.5 mg) tablet and one placebo of Allisartan Isoproxil during the double-blind period (Week 1~Week 12) and one Allisartan Isoproxil/Sustained-Release Indapamide (240 mg/1.5 mg) tablet during the open-label period (Week 13~Week 52) once daily. |
|
| Allisartan Isoproxil Group | Active Comparator | Patients will be treated with one Allisartan Isoproxil (240 mg) and one placebo of Allisartan Isoproxil/Sustained-Release Indapamide (240 mg/1.5 mg) tablet during the double-blind period (Week 1~Week 12) and one Allisartan Isoproxil/Sustained-Release Indapamide (240 mg/1.5 mg) tablet during the open-label period (Week 13~Week 52) once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allisartan Isoproxil/Sustained-Release Indapamide | Drug | Double-blind period (Week 1~Week 12): Allisartan Isoproxil/Sustained-Release Indapamide. Open-label period (Week 13~Week 52): Allisartan Isoproxil/Sustained-Release Indapamide. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment | week 1, week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean seated systolic blood pressure (msSBP) after 4 and 8 weeks of randomized, double-blind treatment | week 1, week 4, week 8. | |
| Change from baseline in mean seated diastolic blood pressure (msDBP) after 4, 8, and 12 weeks of randomized, double-blind treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 24-hour mean systolic and diastolic blood pressure during ambulatory blood pressure monitoring (ABPM) after 12 weeks of randomized, double-blind treatment | week 1, week 12. | |
| Change from baseline in daytime mean systolic and diastolic blood pressure during ambulatory blood pressure monitoring (ABPM) after 12 weeks of randomized, double-blind treatment |
Key Inclusion Criteria:
Patients 18-75 years old with mild to moderate essential hypertension;
Patients who meet one of the following criteria when screening:
During randomization for the double-blind treatment period, msSBP should be 140 mmHg≤ SBP <180 mmHg and DBP<110 mmHg;
Participants enrolled in the ABPM study should have 24-hour mean ambulatory blood pressure ≥130/80 mmHg after 4 weeks of monotherapy treatment;
Patients who understand and sign the informed consent form.
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinxiu Lin, MD | The First Affiliated Hospital of Fujian Medical University, Fuzhou 350212, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | China | |||
| Xuancheng People's Hospital |
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| Allisartan Isoproxil | Drug | Double-blind period (Week 1~Week 12): Allisartan Isoproxil. Open-label period (Week 13~Week 52): Allisartan Isoproxil/Sustained-Release Indapamide. |
|
| week 1, week 4, week 8, week 12. |
| The proportion of responders to antihypertensive treatment after 12 weeks of randomized, double-blind treatment. (Responders are the participants achieving SBP/DBP<140/90 mmHg or a reduction from baseline of >20 mmHg in msSBP and/or >10 mmHg in msDBP. ) | week 1, week 12. |
| The proportion of patients meeting the mean sitting blood pressure target (SBP/DBP <140/90mmHg) after 4, 8, and 12 weeks of randomized, double-blind treatment | week 1, week 4, week 8, week 12. |
| The proportion of patients with the mean sitting blood pressure SBP/DBP <130/80mmHg) after 4, 8, and 12 weeks of randomized, double-blind treatment | week 1, week 4, week 8, week 12. |
| Change from baseline in msSBP after 20, 28, 40, and 52 weeks of treatment | week 1, week 20, week 28, week 40, week 52. |
| Change from baseline in msDBP after 20, 28, 40, and 52 weeks of treatment | week 1, week 20, week 28, week 40, week 52. |
| The proportion of patients meeting the mean sitting blood pressure target (SBP/DBP <140/90mmHg) after 52 weeks of treatment | week 1, week 52. |
| The proportion of patients with the mean sitting blood pressure SBP/DBP <130/80mmHg) after 52 weeks of treatment | week 1, week 52. |
| week 1, week 12. |
| Change from baseline in nighttime mean systolic and diastolic blood pressure during ambulatory blood pressure monitoring (ABPM) after 12 weeks of randomized, double-blind treatment | week 1, week 12. |
| Xuancheng |
| Anhui |
| China |
| Aerospace Central Hospital | Beijing | Beijing Municipality | China |
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | China |
| Chongqing University Affiliated Three Gorges Hospital | Chongqing | Chongqing Municipality | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | China |
| Gansu Provincial People's Hospital | Lanzhou | Gansu | China |
| Shunde Hospital of Southern Medical University | Foshan | Guangdong | China |
| Guangdong Medical University Affiliated Hospital | Zhanjiang | Guangdong | China |
| Nanning First People's Hospital | Nanning | Guangxi | China |
| Hebei Provincial People's Hospital | Shijiazhuang | Hebei | China |
| Shijiazhuang People's Hospital | Shijiazhuang | Hebei | China |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| The Third Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| Daqing People's Hospital | Daqing | Heilongjiang | China |
| Kaifeng Traditional Chinese Medicine Hospital | Kaifeng | Henan | China |
| Chinese Medicine Dongfeng General Hospital | Shiyan | Hubei | China |
| Wuhan First Hospital | Wuhan | Hubei | China |
| Wuhan Fourth Hospital | Wuhan | Hubei | China |
| Wuhan Sixth Hospital | Wuhan | Hubei | China |
| Xiangya Second Hospital of Central South University | Changsha | Hunan | China |
| Yueyang Central Hospital | Yueyang | Hunan | China |
| Yueyang People's Hospital | Yueyang | Hunan | China |
| Huai'an First People's Hospital | Huai'an | Jiangsu | China |
| Suzhou Municipal Hospital | Suzhou | Jiangsu | China |
| Xuzhou Central Hospital | Xuzhou | Jiangsu | China |
| Ganzhou People's Hospital | Ganzhou | Jiangxi | China |
| The First Affiliated Hospital of Gannan Medical College | Ganzhou | Jiangxi | China |
| Pingxiang People's Hospital | Pingxiang | Jiangxi | China |
| Tonghua Central Hospital | Tonghua | Jilin | China |
| The Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | China |
| Shanxi Provincial People's Hospital | Xi’an | Shanxi | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | China |
| Nanchong Central Hospital | Nanchong | Sichuan | China |
| Suining Central Hospital | Suining | Sichuan | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | China |
| The Second Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | China |
| Li Huili Hospital of Ningbo Medical Center | Ningbo | Zhejiang | China |
| Quzhou People's Hospital | Quzhou | Zhejiang | China |
| Wenzhou Medical University Affiliated First Hospital | Wenzhou | Zhejiang | China |
| 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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