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HypertensionPhase 3NCT05820880

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

A Phase 3 study testing Fixed [Per/Ind/Aml] and Free [Per/Ind + Aml] in people with Hypertension, run by Institut de Recherches Internationales Servier at 42 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
Fixed [Per/Ind/Aml] and Free [Per/Ind + Aml]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
532 participants
Where
42 sitesChina
Study dates
6 May 2019to 23 Feb 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

China42 sites

  • The First Affiliated Hosptial of Baotou Medical college, Innter Mongolia University of Science & Technology

    Baotou, Inner Mongolia

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality

  • Xuanwu Hospital Capital Medical Universtiy

    Beijing, Beijing Municipality

  • Jilin university China-Japan Union Hospital

    Changchun, Jilin

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • Xiangya Hospital of Central South University

    Changsha, Hunan

  • The First affiliated hospital Chongqing Medical University

    Chongqing, Chongqing Municipality

  • The second affiliated hospital of Chongqing medical university

    Chongqing, Chongqing Municipality

  • First affiliated hospital of Dalian medical university

    Dalian, Liaoning

  • Daqing Oilfield general hospital

    Daqing, Liaonig

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

  • The first affiliated hospital of Fujian medical university

    Fuzhou, Fujian

  • The First affiliated hospital of Harbin Medical University

    Harbin, Heilongjiang

  • Inner Mongolia People's Hospital

    Hohhot, Inner Mongolia

  • Shandong Provincial Qianfoshan Hospita

    Jinan, Shandong

  • Lanzhou University Second Hospital

    Lanzhou, Gansu

  • Linyi People's Hospital

    Linyi, Shandong

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi

  • The First affiliated hospital of Nanchang University

    Nanchang, Jiangxi

  • The Second affiliated hospital of Nanchang University

    Nanchang, Jiangxi

  • The Affiliated Jiangning Hospital of Nanjing Medical University

    Nanjing, Nanjing

  • Ruijin Hospital affiliated to Shanghai Jiaotong University

    Shanghai, Shanghai Municipality

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

  • The People's Hospital of Liaoning Province

    Shenyang, Liaoning

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality

  • Tianjin People's hospital

    Tianjin, Tianjin Municipality

  • People's Hospital of Xinjiang Uyghur Autonomous Region

    Ürümqi, Uyghur Autonomous Region

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

  • Wuxi Second People's Hospital

    Wuxi, Jiangsu

  • The First Affiliated Hospital, School of Medicine of Xi'an Jiaotong University

    Xi’an, Shanxi

  • Qinghai Provincial People's Hospital

    Xining, Qinghai

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, Jiangshu

  • Xuzhou Central Hospital

    Xuzhou, Jiangshu

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu

  • Yangzhou First People's Hospital

    Yangzhou, Jiangsu

  • Zaozhuang Municipal Hospital

    Zaozhuang, Shandong

  • The First affiliated hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

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.

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.

Conditions
Hypertension
Being tested
Fixed [Per/Ind/Aml], Free [Per/Ind + Aml]
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fixed [Per/Ind/Aml]Drug

    Fixed Dose combination of Perindopril/Indapamide/Amlodipine

  • Free [Per/Ind + Aml]Drug

    Free dose combination of Perindopril/Indapamide and Amlodipine

Study groups in NCT05820880
Study groupRoleWhat they receive
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.
Receives: Drug: Fixed [Per/Ind/Aml]
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.
Receives: Drug: Free [Per/Ind + Aml]

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline safety visit, Month 2 follow-up visit

Secondary outcomes (13)

  1. Sitting SBP change from month 2 to month 4

    Office sitting Systolic Blood Pressure (SBP) change from month 2 to month 4

    Measured: Month 2 follow-up visit, Month 4 follow-up visit

  2. Sitting SBP change from month 4 to month 6

    Office sitting Systolic Blood Pressure (SBP) change from month 4 to month 6

    Measured: Month 4 follow-up visit, Month 6 follow-up visit

  3. 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

    Measured: Baseline safety visit, Month 2 follow-up visit

  4. Sitting DBP change from month 2 to month 4

    Office sitting Diastolic Blood Pressure (DBP) change from month 2 to month 4

    Measured: Month 2 follow-up visit, Month 4 follow-up visit

  5. Sitting DBP change from month 4 to month 6

    Office sitting Diastolic Blood Pressure (DBP) change from month 4 to month 6

    Measured: Month 4 follow-up visit, Month 6 follow-up visit

  6. 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

    Measured: Baseline safety visit, Month 2 follow-up visit

  7. 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

    Measured: Month 2 follow-up visit, Month 4 follow-up visit

  8. 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

    Measured: Month 4 follow-up visit, Month 6 follow-up visit

  9. 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

    Measured: Baseline safety visit, Month 2 follow-up visit

  10. 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.

    Measured: Month 2 follow-up visit

  11. 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

    Measured: Month 2 follow-up visit

  12. Adverse events between Month 0 and Month 2

    Number experiencing treatment emergent adverse events between month 0 and month 2

    Measured: Up to the 2 month follow-up visit

  13. Adverse events between Month 0 and Month 6

    Number experiencing treatment emergent adverse events between month 0 and month 6

    Measured: Up to the 6 month final visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2023
  2. Study start6 May 2019
  3. Primary completion23 Feb 2022
  4. Study completion23 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
532 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05820880
Sponsor's protocol ID
CL3-6593-018
Status last verified
Jul 2024
First submitted
28 Feb 2023
Last updated
25 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1st January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

Publications

  • 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.

    PubMed 38660708

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fixed [Per/Ind/Aml] and Free [Per/Ind + Aml] in people with Hypertension, run by Institut de Recherches Internationales Servier at 42 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sitting SBP change after two months of treatment (time frame: Baseline safety visit, Month 2 follow-up visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05820880, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.

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