Clinical trial NCT05820880: Efficacy and Safety of Perindopril 5 mg / Indapamide 1.25 mg / Amlodipine 5 mg Fixed Combination in Hypertension
Official title: Evaluation of the Clinical Efficacy and Safety of Perindopril 5 mg / Indapamide 1.25 mg / Amlodipine 5 mg Fixed Combination in Single-pill After 2 Months of Treatment Versus Free Combination, Perindopril 4 mg / Indapamide 1.25 mg + Amlodipine 5 mg Given Separately at the Same Time, With Conditional Titration Based on Blood Pressure Control in Patients With Essential Hypertension Uncontrolled After 1 Month With Perindopril 4 mg / Indapamide 1.25 mg Bi-therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Servier
Sponsor class: INDUSTRY
First posted: 2023-04-20
Enrollment: 532
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety of a fixed-dose combination of perindopril 5 mg /indapamide 1.25 mg / amlodipine 5 mg compared to the free combination of the same components (perindopril 4 mg / indapamide 1.25 mg in a single pill and amlodipine 5 mg pill given separately at the same time) in chinese patients with uncontrolled essential hypertension.


Eligibility criteria: Main Inclusion Criteria:

* Men or women of Asian origin
* ≥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

Main Exclusion Criteria:

* Known or suspected symptomatic orthostatic hypotension or positive orthostatic test at the selection visit
* Treatment with more than 2 antihypertensive drugs or with 2 antihypertensive drugs at the highest doses at the selection visit

Primary outcomes:
measure: Sitting SBP change after two months of treatment
timeFrame: Baseline safety visit, Month 2 follow-up visit
Secondary outcomes:
measure: Sitting SBP change from month 2 to month 4
timeFrame: Month 2 follow-up visit, Month 4 follow-up visit
measure: Sitting SBP change from month 4 to month 6
timeFrame: Month 4 follow-up visit, Month 6 follow-up visit
measure: Sitting DBP change after two months of treatment
timeFrame: Baseline safety visit, Month 2 follow-up visit
measure: Sitting DBP change from month 2 to month 4
timeFrame: Month 2 follow-up visit, Month 4 follow-up visit
measure: Sitting DBP change from month 4 to month 6
timeFrame: Month 4 follow-up visit, Month 6 follow-up visit
measure: Sitting Mean Arterial Pressure change after two months of treatment
timeFrame: Baseline safety visit, Month 2 follow-up visit
measure: Sitting Mean Arterial Pressure change from month 2 to month 4
timeFrame: Month 2 follow-up visit, Month 4 follow-up visit
measure: Sitting Mean Arterial Pressure change from month 4 to month 6
timeFrame: Month 4 follow-up visit, Month 6 follow-up visit
measure: Sitting Pulse Pressure change after two months of treatment
timeFrame: Baseline safety visit, Month 2 follow-up visit
measure: Response to the treatment at two months
timeFrame: Month 2 follow-up visit
measure: Control of Blood Pressure at two months
timeFrame: Month 2 follow-up visit
measure: Adverse events between Month 0 and Month 2
timeFrame: Up to the 2 month follow-up visit
measure: Adverse events between Month 0 and Month 6
timeFrame: Up to the 6 month final visit
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical Universtiy
state: Beijing
city: Chongqing
country: China
facility: The First affiliated hospital Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: The second affiliated hospital of Chongqing medical university
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: The first affiliated hospital of Fujian medical university
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: The First affiliated hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First affiliated hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Baotou
country: China
facility: The First Affiliated Hosptial of Baotou Medical college, Innter Mongolia University of Science & Technology
state: Inner Mongolia
city: Hohhot
country: China
facility: Inner Mongolia People's Hospital
state: Inner Mongolia
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College
state: Jiangshu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangshu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Second People's Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Yangzhou First People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The First affiliated hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Second affiliated hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: Jilin university China-Japan Union Hospital
state: Jilin
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Daqing
country: China
facility: Daqing Oilfield general hospital
state: Liaonig
city: Dalian
country: China
facility: First affiliated hospital of Dalian medical university
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Province
state: Liaoning
city: Nanjing
country: China
facility: The Affiliated Jiangning Hospital of Nanjing Medical University
state: Nanjing
city: Xining
country: China
facility: Qinghai Provincial People's Hospital
state: Qinghai
city: Jinan
country: China
facility: Shandong Provincial Qianfoshan Hospita
state: Shandong
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
city: Zaozhuang
country: China
facility: Zaozhuang Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiaotong University
state: Shanghai
city: Taiyuan
country: China
facility: The First Hospital of Shanxi Medical University
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital, School of Medicine of Xi'an Jiaotong University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin People's hospital
state: Tianjin
city: Ürümqi
country: China
facility: People's Hospital of Xinjiang Uyghur Autonomous Region
state: Uyghur Autonomous Region
Study officials:
References:
citation: 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.