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

Phase 3CompletedNCT05820880

Institut de Recherches Internationales Servier532 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

532

Conditions

Hypertension

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (42)

Outcomes

Primary Outcomes

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

Time frame: Baseline safety visit, Month 2 follow-up visit

Secondary Outcomes

Sitting SBP change from month 2 to month 4

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

Time frame: Month 2 follow-up visit, Month 4 follow-up visit

Sitting SBP change from month 4 to month 6

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Xuanwu Hospital Capital Medical Universtiy

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

...and 32 more locations

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Up to the 6 month final visit