Efficacy and Safety of Perindopril 5 mg / Indapamide 1.25 mg / Amlodipine 5 mg Fixed Combination in Hypertension

Hypertension Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05820880
• Other study ID #: CL3-6593-018
• Status: Completed
• Phase: Phase 3
• Start date: May 6, 2019
• Est. completion date: February 23, 2022

Study information

• Verified date: April 2023
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 532
• Est. completion date: February 23, 2022
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Fixed [Per/Ind/Aml]
Fixed Dose combination of Perindopril/Indapamide/Amlodipine
• Free [Per/Ind + Aml]
Free dose combination of Perindopril/Indapamide and Amlodipine

Locations

Country	Name	City	State
China	The First Affiliated Hosptial of Baotou Medical college, Innter Mongolia University of Science & Technology	Baotou	Inner Mongolia
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Xuanwu Hospital Capital Medical Universtiy	Beijing	Beijing
China	Jilin university China-Japan Union Hospital	Changchun	Jilin
China	The First Bethune Hospital of Jilin University	Changchun	Jilin
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	The First affiliated hospital Chongqing Medical University	Chongqing	Chongqing
China	The second affiliated hospital of Chongqing medical university	Chongqing	Chongqing
China	First affiliated hospital of Dalian medical university	Dalian	Liaoning
China	Daqing Oilfield general hospital	Daqing	Liaonig
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	The first affiliated hospital of Fujian medical university	Fuzhou	Fujian
China	The First affiliated hospital of Harbin Medical University	Harbin	Heilongjiang
China	Inner Mongolia People's Hospital	Hohhot	Inner Mongolia
China	Shandong Provincial Qianfoshan Hospita	Jinan	Shandong
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	Linyi People's Hospital	Linyi	Shandong
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	The Affiliated Jiangning Hospital of Nanjing Medical University	Nanjing	Nanjing
China	Ruijin Hospital affiliated to Shanghai Jiaotong University	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	The People's Hospital of Liaoning Province	Shenyang	Liaoning
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Tianjin People's hospital	Tianjin	Tianjin
China	People's Hospital of Xinjiang Uyghur Autonomous Region	Ürümqi	Uyghur Autonomous Region
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	Wuxi Second People's Hospital	Wuxi	Jiangsu
China	The First Affiliated Hospital, School of Medicine of Xi'an Jiaotong University	Xi'an	Shanxi
China	Qinghai Provincial People's Hospital	Xining	Qinghai
China	The Affiliated Hospital of Xuzhou Medical College	Xuzhou	Jiangshu
China	Xuzhou Central Hospital	Xuzhou	Jiangshu
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu
China	Yangzhou First People's Hospital	Yangzhou	Jiangsu
China	Zaozhuang Municipal Hospital	Zaozhuang	Shandong
China	The First affiliated hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherches Internationales Servier

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Sitting SBP change from month 4 to month 6	Office sitting Systolic Blood Pressure (SBP) change from month 4 to month 6	Month 4 follow-up visit, Month 6 follow-up visit
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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