Efficacy and Safety of Perindopril 5 mg / Indapamide 1.25 mg / Amlodipine 5 mg Fixed Combination in Hypertension
- Conditions
- Hypertension
- Interventions
- Drug: Free [Per/Ind + Aml]Drug: Fixed [Per/Ind/Aml]
- Registration Number
- NCT05820880
- Lead Sponsor
- Institut de Recherches Internationales Servier
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 532
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Free [Per/Ind + Aml] 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. Fixed [Per/Ind/Aml] 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.
- Primary Outcome Measures
Name Time Method Sitting SBP change after two months of treatment Baseline safety visit, Month 2 follow-up visit Office sitting Systolic Blood Pressure (SBP) change from baseline to last post-baseline value over the period from Month 0 to month 2
- Secondary Outcome Measures
Name Time Method Sitting DBP change after two months of treatment Baseline safety visit, Month 2 follow-up visit Office sitting Diastolic Blood Pressure (DBP) change from baseline to last post-baseline value over the period from Month 0 to month 2
Sitting DBP change from month 4 to month 6 Month 4 follow-up visit, Month 6 follow-up visit Office sitting Diastolic Blood Pressure (DBP) change from month 4 to month 6
Sitting SBP change from month 4 to month 6 Month 4 follow-up visit, Month 6 follow-up visit Office sitting Systolic Blood Pressure (SBP) change from month 4 to month 6
Sitting DBP change from month 2 to month 4 Month 2 follow-up visit, Month 4 follow-up visit Office sitting Diastolic Blood Pressure (DBP) change from month 2 to month 4
Sitting Pulse Pressure change after two months of treatment Baseline safety visit, Month 2 follow-up visit 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
Sitting SBP change from month 2 to month 4 Month 2 follow-up visit, Month 4 follow-up visit Office sitting Systolic Blood Pressure (SBP) change from month 2 to month 4
Sitting Mean Arterial Pressure change from month 2 to month 4 Month 2 follow-up visit, Month 4 follow-up visit Sitting Mean Arterial Pressure (MAP) change from from month 2 to month 4 , with MAP=2/3 DBP+1/3 SBP
Adverse events between Month 0 and Month 2 Up to the 2 month follow-up visit Number experiencing treatment emergent adverse events between month 0 and month 2
Adverse events between Month 0 and Month 6 Up to the 6 month final visit Number experiencing treatment emergent adverse events between month 0 and month 6
Sitting Mean Arterial Pressure change after two months of treatment Baseline safety visit, Month 2 follow-up visit 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
Sitting Mean Arterial Pressure change from month 4 to month 6 Month 4 follow-up visit, Month 6 follow-up visit Sitting Mean Arterial Pressure (MAP) change from from month 4 to month 6, with MAP=2/3 DBP+1/3 SBP
Response to the treatment at two months Month 2 follow-up visit 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.
Control of Blood Pressure at two months Month 2 follow-up visit Number of patients with Blood pressure controlled, ie : with sitting SBP \<140 mmHg and sitting DBP \< 90 mmHg
Trial Locations
- Locations (42)
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Xuanwu Hospital Capital Medical Universtiy
🇨🇳Beijing, Beijing, China
The First affiliated hospital Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The second affiliated hospital of Chongqing medical university
🇨🇳Chongqing, Chongqing, 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
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