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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed [Per/Ind/Aml] | Experimental | 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. |
|
| Free [Per/Ind + Aml] | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed [Per/Ind/Aml] | Drug | Fixed Dose combination of Perindopril/Indapamide/Amlodipine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sitting SBP change from month 2 to month 4 | Office sitting Systolic Blood Pressure (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 |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | China | |||
| Xuanwu Hospital Capital Medical Universtiy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38660708 | Background | 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. |
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| Free [Per/Ind + Aml] | Drug | Free dose combination of Perindopril/Indapamide and Amlodipine |
|
Office sitting Systolic Blood Pressure (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 | Office sitting Diastolic Blood Pressure (DBP) 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 |
| Sitting DBP change from month 2 to month 4 | Office sitting Diastolic Blood Pressure (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 | Office sitting Diastolic Blood Pressure (DBP) change from month 4 to month 6 | Month 4 follow-up visit, Month 6 follow-up visit |
| Sitting Mean Arterial Pressure change after two months of treatment | Sitting Mean Arterial Pressure (MAP) change from baseline to last post-baseline value over the period from Month 0 to month 2 with MAP=2/3 DBP+1/3 SBP | Baseline safety visit, Month 2 follow-up visit |
| Sitting Mean Arterial Pressure change from month 2 to month 4 | Sitting Mean Arterial Pressure (MAP) change from from month 2 to month 4 , with MAP=2/3 DBP+1/3 SBP | Month 2 follow-up visit, Month 4 follow-up visit |
| Sitting Mean Arterial Pressure change from month 4 to month 6 | Sitting Mean Arterial Pressure (MAP) change from from month 4 to month 6, with MAP=2/3 DBP+1/3 SBP | Month 4 follow-up visit, Month 6 follow-up visit |
| Sitting Pulse Pressure change after two months of treatment | Sitting Pulse Pressure change from baseline to last post-baseline value over the period from Month 0 to month 2, with Pulse Pressure=SBP-DBP | Baseline safety visit, Month 2 follow-up visit |
| Response to the treatment at two months | Number of patients responders, ie: with control of Blood Pressure : sitting SBP <140 mmHg and sitting DBP <90 mmHg) and/or sitting SBP decrease from baseline ≥20 mmHg or sitting DBP decrease from baseline ≥10 mmHg. | Month 2 follow-up visit |
| Control of Blood Pressure at two months | Number of patients with Blood pressure controlled, ie : with sitting SBP <140 mmHg and sitting DBP < 90 mmHg | Month 2 follow-up visit |
| Adverse events between Month 0 and Month 2 | Number experiencing treatment emergent adverse events between month 0 and month 2 | Up to the 2 month follow-up visit |
| Adverse events between Month 0 and Month 6 | Number experiencing treatment emergent adverse events between month 0 and month 6 | Up to the 6 month final visit |
| 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 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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