Efficacy and Safety of Perindopril 5 mg / Indapamide 1.25 mg / Amlodipine 5 mg Fixed Combination in Hypertension
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.
1 other identifier
interventional
532
1 country
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hypertension
Started May 2019
Typical duration for phase_3 hypertension
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2022
CompletedFirst Submitted
Initial submission to the registry
February 28, 2023
CompletedFirst Posted
Study publicly available on registry
April 20, 2023
CompletedJuly 25, 2024
July 1, 2024
2.8 years
February 28, 2023
July 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Sitting SBP change after two months of treatment
Office sitting Systolic Blood Pressure (SBP) change from baseline to last post-baseline value over the period from Month 0 to month 2
Baseline safety visit, Month 2 follow-up visit
Secondary Outcomes (13)
Sitting SBP change from month 2 to month 4
Month 2 follow-up visit, Month 4 follow-up visit
Sitting SBP change from month 4 to month 6
Month 4 follow-up visit, Month 6 follow-up visit
Sitting DBP change after two months of treatment
Baseline safety visit, Month 2 follow-up visit
Sitting DBP change from month 2 to month 4
Month 2 follow-up visit, Month 4 follow-up visit
Sitting DBP change from month 4 to month 6
Month 4 follow-up visit, Month 6 follow-up visit
- +8 more secondary outcomes
Study Arms (2)
Fixed [Per/Ind/Aml]
EXPERIMENTALFrom 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.
Free [Per/Ind + Aml]
ACTIVE COMPARATORFrom 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.
Interventions
Fixed Dose combination of Perindopril/Indapamide/Amlodipine
Free dose combination of Perindopril/Indapamide and Amlodipine
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
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
Related Publications (1)
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.
PMID: 38660708BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2023
First Posted
April 20, 2023
Study Start
May 6, 2019
Primary Completion
February 23, 2022
Study Completion
February 23, 2022
Last Updated
July 25, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After Marketing Authorisation in EEA or US if the study is used for the approval.
- Access Criteria
- Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
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