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

Sponsor
Institut de Recherches Internationales Servier (Other)
Overall Status
Completed
CT.gov ID
NCT05820880
Collaborator
(none)
532
Enrollment
42
Locations
2
Arms
33.6
Actual Duration (Months)
12.7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Fixed [Per/Ind/Aml]
  • Drug: Free [Per/Ind + Aml]
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
532 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
May 6, 2019
Actual Primary Completion Date :
Feb 23, 2022
Actual Study Completion Date :
Feb 23, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Fixed [Per/Ind/Aml]
Fixed Dose combination of Perindopril/Indapamide/Amlodipine
Active Comparator: 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.

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  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

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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

  12. 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

  13. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 China-Japan Friendship Hospital Beijing Beijing China
2 Xuanwu Hospital Capital Medical Universtiy Beijing Beijing China
3 The First affiliated hospital Chongqing Medical University Chongqing Chongqing China
4 The second affiliated hospital of Chongqing medical university Chongqing Chongqing China
5 Fujian Medical University Union Hospital Fuzhou Fujian China
6 The first affiliated hospital of Fujian medical university Fuzhou Fujian China
7 Lanzhou University Second Hospital Lanzhou Gansu China
8 The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei China
9 The First affiliated hospital of Harbin Medical University Harbin Heilongjiang China
10 The First affiliated hospital of Zhengzhou University Zhengzhou Henan China
11 Renmin Hospital of Wuhan University Wuhan Hubei China
12 Zhongnan Hospital of Wuhan University Wuhan Hubei China
13 The Third Xiangya Hospital of Central South University Changsha Hunan China
14 Xiangya Hospital of Central South University Changsha Hunan China
15 The First Affiliated Hosptial of Baotou Medical college, Innter Mongolia University of Science & Technology Baotou Inner Mongolia China
16 Inner Mongolia People's Hospital Hohhot Inner Mongolia China
17 The Affiliated Hospital of Xuzhou Medical College Xuzhou Jiangshu China
18 Xuzhou Central Hospital Xuzhou Jiangshu China
19 The Second Affiliated Hospital of Soochow University Suzhou Jiangsu China
20 Wuxi Second People's Hospital Wuxi Jiangsu China
21 Northern Jiangsu People's Hospital Yangzhou Jiangsu China
22 Yangzhou First People's Hospital Yangzhou Jiangsu China
23 Jiangxi Provincial People's Hospital Nanchang Jiangxi China
24 The First affiliated hospital of Nanchang University Nanchang Jiangxi China
25 The Second affiliated hospital of Nanchang University Nanchang Jiangxi China
26 Jilin university China-Japan Union Hospital Changchun Jilin China
27 The First Bethune Hospital of Jilin University Changchun Jilin China
28 Daqing Oilfield general hospital Daqing Liaonig China
29 First affiliated hospital of Dalian medical university Dalian Liaoning China
30 Shengjing Hospital of China Medical University Shenyang Liaoning China
31 The People's Hospital of Liaoning Province Shenyang Liaoning China
32 The Affiliated Jiangning Hospital of Nanjing Medical University Nanjing Nanjing China
33 Qinghai Provincial People's Hospital Xining Qinghai China
34 Shandong Provincial Qianfoshan Hospita Jinan Shandong China
35 Linyi People's Hospital Linyi Shandong China
36 Zaozhuang Municipal Hospital Zaozhuang Shandong China
37 Ruijin Hospital affiliated to Shanghai Jiaotong University Shanghai Shanghai China
38 The First Hospital of Shanxi Medical University Taiyuan Shanxi China
39 The First Affiliated Hospital, School of Medicine of Xi'an Jiaotong University Xi'an Shanxi China
40 Tianjin Medical University General Hospital Tianjin Tianjin China
41 Tianjin People's hospital Tianjin Tianjin China
42 People's Hospital of Xinjiang Uyghur Autonomous Region Ürümqi Uyghur Autonomous Region China

Sponsors and Collaborators

  • Institut de Recherches Internationales Servier

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier:
NCT05820880
Other Study ID Numbers:
  • CL3-6593-018
First Posted:
Apr 20, 2023
Last Update Posted:
Apr 20, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypertension

Study Results

No Results Posted as of Apr 20, 2023