Efficacy and Safety of Perindopril 5 mg / Indapamide 1.25 mg / Amlodipine 5 mg Fixed Combination in Hypertension
NCT ID: NCT05820880
Last Updated: 2024-07-25
Study Results
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Basic Information
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COMPLETED
PHASE3
532 participants
INTERVENTIONAL
2019-05-06
2022-02-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Fixed [Per/Ind/Aml]
From inclusion to Month 2, patients receive the fixed combination of perindopril 5 mg / indapamide 1.25 mg / amlodipine 5 mg (S06593).
From Month 2 to 4, patients either stay at the same dose if the blood pressure is controlled, either are up-titrated to the next dose of the strategy if the blood pressure is not controlled (ie, perindopril 10 mg / indapamide 2.5 mg / amlodipine 5 mg).
From Month 4 to 6, patients either stay at the same dose if the blood pressure is controlled, either are up-titrated to the next dose of the strategy if the blood pressure is not controlled (ie, for patients who were up-titrated at Month 2 visit: perindopril 10 mg / indapamide 2.5 mg / amlodipine 10 mg or for patients who were not yet up-titrated: perindopril 10 mg / indapamide 2.5 mg / amlodipine 5 mg.
Fixed [Per/Ind/Aml]
Fixed Dose combination of Perindopril/Indapamide/Amlodipine
Free [Per/Ind + Aml]
From inclusion to Month 2, patients receive the free combination of perindopril 4 mg / indapamide 1.25 mg plus amlodipine 5 mg.
From Month 2 to 4, patients either stay at the same dose if the blood pressure is controlled, either are up-titrated to the next dose of the strategy if the blood pressure is not controlled (ie, double dose of perindopril 4 mg / indapamide 1.25 mg plus amlodipine 5 mg for patients).
From Month 4 to 6, patients either stay at the same dose if the blood pressure is controlled, either are up-titrated to the next dose of the strategy if the blood pressure is not controlled (ie for patients who were up-titrated at Month 2 visit: double dose of perindopril 4 mg / indapamide 1.25 mg plus double dose of amlodipine 5 mg or for patients who were not yet up-titrated:double dose of perindopril 4 mg / indapamide 1.25 mg plus amlodipine 5 mg.
Free [Per/Ind + Aml]
Free dose combination of Perindopril/Indapamide and Amlodipine
Interventions
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Fixed [Per/Ind/Aml]
Fixed Dose combination of Perindopril/Indapamide/Amlodipine
Free [Per/Ind + Aml]
Free dose combination of Perindopril/Indapamide and Amlodipine
Eligibility Criteria
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Inclusion Criteria
* ≥18 years old
* Treated for essential hypertension
* Having the day of the selection visit an uncontrolled hypertension treated with any anti-hypertensive monotherapy at maximal dose or any dual therapy at starting dose according to investigator's routine practice or at least 1 month prior to the visit
* Having at the selection visit a sitting SBP≥140 and \<180 mmHg and DBP≥90 and \<110 mmHg
Exclusion Criteria
* Treatment with more than 2 antihypertensive drugs or with 2 antihypertensive drugs at the highest doses at the selection visit
18 Years
ALL
No
Sponsors
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Institut de Recherches Internationales Servier
OTHER
Responsible Party
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Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Xuanwu Hospital Capital Medical Universtiy
Beijing, Beijing Municipality, China
The First affiliated hospital Chongqing Medical University
Chongqing, Chongqing Municipality, China
The second affiliated hospital of Chongqing medical university
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The first affiliated hospital of Fujian medical university
Fuzhou, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First affiliated hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First affiliated hospital of Zhengzhou University
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hosptial of Baotou Medical college, Innter Mongolia University of Science & Technology
Baotou, Inner Mongolia, China
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangshu, China
Xuzhou Central Hospital
Xuzhou, Jiangshu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Wuxi Second People's Hospital
Wuxi, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Yangzhou First People's Hospital
Yangzhou, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
The First affiliated hospital of Nanchang University
Nanchang, Jiangxi, China
The Second affiliated hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin university China-Japan Union Hospital
Changchun, Jilin, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Daqing Oilfield general hospital
Daqing, Liaonig, China
First affiliated hospital of Dalian medical university
Dalian, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, China
The Affiliated Jiangning Hospital of Nanjing Medical University
Nanjing, Nanjing, China
Qinghai Provincial People's Hospital
Xining, Qinghai, China
Shandong Provincial Qianfoshan Hospita
Jinan, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, China
Ruijin Hospital affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The First Affiliated Hospital, School of Medicine of Xi'an Jiaotong University
Xi’an, Shanxi, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Tianjin People's hospital
Tianjin, Tianjin Municipality, China
People's Hospital of Xinjiang Uyghur Autonomous Region
Ürümqi, Uyghur Autonomous Region, China
Countries
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References
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Wang JG, Topouchian J, Bricout-Hennel S, Mu J, Chen L, Li P, He S, Luo S, Jiang W, Jiang Y, Sun Y, Zhang Y, Asmar R. Efficacy and safety of a single-pill versus free combination of perindopril/indapamide/amlodipine: a multicenter, randomized, double-blind study in Chinese patients with hypertension. J Hypertens. 2024 Aug 1;42(8):1373-1381. doi: 10.1097/HJH.0000000000003741. Epub 2024 Apr 24.
Other Identifiers
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CL3-6593-018
Identifier Type: -
Identifier Source: org_study_id
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