To Assess Allisartan Isoproxil/Sustained-Release Indapamide in Patients With Essential Hypertension Uncontrolled With Allisartan Isoproxil
NCT Number: NCT06500689
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Essential Hypertension
Interventions: DRUG: Allisartan Isoproxil/Sustained-Release Indapamide|DRUG: Allisartan Isoproxil
Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 366
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-12-30
Completion Date: 2024-05-24
Locations: The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China|Xuancheng People's Hospital, Xuancheng, Anhui, China|Aerospace Central Hospital, Beijing, Beijing, China|China-Japan Friendship Hospital, Beijing, Beijing, China|Chongqing University Affiliated Three Gorges Hospital, Chongqing, Chongqing, 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, 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

Summary:
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).

Primary Outcome Measures: Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment, week 1, week 12.
Secondary Outcome Measures: 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, 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.
Other Outcome Measures: 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, 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.