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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
366
Double-blind period (Week 1\~Week 12): Allisartan Isoproxil/Sustained-Release Indapamide. Open-label period (Week 13\~Week 52): Allisartan Isoproxil/Sustained-Release Indapamide.
Double-blind period (Week 1\~Week 12): Allisartan Isoproxil. Open-label period (Week 13\~Week 52): Allisartan Isoproxil/Sustained-Release Indapamide.
Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment
Time frame: week 1, week 12.
Change from baseline in mean seated systolic blood pressure (msSBP) after 4 and 8 weeks of randomized, double-blind treatment
Time frame: 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
Time frame: 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. )
Time frame: 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
Time frame: 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
Time frame: week 1, week 4, week 8, week 12.
Change from baseline in msSBP after 20, 28, 40, and 52 weeks of treatment
Time frame: week 1, week 20, week 28, week 40, week 52.
Change from baseline in msDBP after 20, 28, 40, and 52 weeks of treatment
Time frame: week 1, week 20, week 28, week 40, week 52.
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
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China-Japan Friendship Hospital
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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
...and 30 more locations
The proportion of patients meeting the mean sitting blood pressure target (SBP/DBP <140/90mmHg) after 52 weeks of treatment
Time frame: week 1, week 52.
The proportion of patients with the mean sitting blood pressure SBP/DBP <130/80mmHg) after 52 weeks of treatment
Time frame: week 1, week 52.