Delving into the Latest Updates on Perindopril Arginine/ Indapamide/Amlodipine with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

S06593, Triplixam

Target

ACE x VDCCs

Mechanism

ACE inhibitors(Angiotensin-converting enzyme inhibitors), VDCCs blockers(Voltage-gated calcium channel blockers), Symporters inhibitors

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Essential Hypertension

Inactive Indication-

Originator Organization

Les Laboratoires Servier SAS

Active Organization

Les Laboratoires Servier SAS

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

SG (23 May 2016),

Essential Hypertension

Regulation-

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Structure/Sequence

Molecular FormulaC20H25ClN2O5

InChIKeyHTIQEAQVCYTUBX-UHFFFAOYSA-N

CAS Registry88150-42-9

View All Structures (3)

This is a multi-centre, observational, ambispective study, which will retrospectively and prospectively collect clinical and socio-demographic data from medical records of outpatients with arterial hypertension (HTN) initiated with the amlodipine/indapamide/perindopril SPC in real clinical settings.
375 patients to be included in the study in order for at least 300 patients to complete the study and provide an estimated 90% power of the study.
75 outpatient general practitioners and cardiologists will participate in this study.

Start Date01 May 2024

Sponsor / Collaborator

Servier Russia

NCT06275763

/ RecruitingPhase 4IIT

Optimal Medical Treatment of Difficult-to-treat Hypertension

The purpose of this study is to evaluate best medical management to achieve the BP goals of ESC/ESH (120-129 / 70-79 mmHg) in HT patients who are <65 years old and ineffectively treated (BP ≥ 130/80 mg) with 3 or more antihypertensive drugs

Start Date20 Oct 2023

Sponsor / Collaborator-

NCT05470764

/ CompletedPhase 1

Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover, Comparative, Oral Bioequivalence Study of Test Product PERINDOPRES® TRIO, 8 mg Perindopril Tert-Butylamine / 2.5 mg Indapamide/ 10 mg Amlodipine Tablets (PrJSC "Pharmaceutical Firm "Darnitsa") And Reference Product TRIPLIXAM® 10 mg /2.5 mg/10 mg, 10 mg Perindopril Arginine / 2.5 mg Indapamide / 10 mg Amlodipine Film-Coated Tablets (Manufactured By Servier (Ireland) Industries Ltd) In Healthy, Adult Subjects Under Fasting Conditions

The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (PERINDOPRES® TRIO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide / 10 mg amlodipine tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine]) and a Reference medication (marketed medicinal product TRIPLIXAM® 10 mg /2.5 mg/10 mg, 10 mg perindopril arginine / 2.5 mg indapamide / 10 mg amlodipine film-coated tablets [manufactured by Servier (Ireland) Industries Ltd]) in healthy adult volunteers under fasting conditions.

Start Date30 May 2021

Sponsor / Collaborator

Darnitsa Pharmaceutical Co.

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100 Clinical Results associated with Perindopril Arginine/ Indapamide/Amlodipine

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100 Translational Medicine associated with Perindopril Arginine/ Indapamide/Amlodipine

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100 Patents (Medical) associated with Perindopril Arginine/ Indapamide/Amlodipine

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6

Literatures (Medical) associated with Perindopril Arginine/ Indapamide/Amlodipine

03 May 2023·Journal of AOAC International

In Vitro Dissolution Profile of Antihypertensive Mixture: Comparison Between Multivariate Methods and Statistical and Graphical Representation of Different Univariate Spectrophotometric Data

Article

Author: Magdy, Ragaa ; Fares, Nermine V ; Farouk, Maha ; Hemdan, Ahmed

Abstract:

Background:

Triplixam® is a new antihypertensive drug combination consisting of perindopril, amlodipine, and indapamide, which have a synergistic mechanism of action in combination with each other.

Objective:

Comparative study of different spectrophotometric approaches used for the simultaneous determination of perindopril, indapamide, and amlodipine in bulk powder and in dosage form Triplixam.

Method:

The methods include univariate and multivariate spectrophotometric methods depending on either mathematical calculation or graphical representation of data. For the univariate methods: perindopril was resolved from other components using constant multiplication followed by spectrum subtraction resolution technique, and then two base point, AUC, constant value, and concentration value (CNV) methods were applied. For both amlodipine and indapamide: constant multiplication resolution technique was used, and then constant value and CNV methods were applied. CNV depends on graphical representation of data rather than statistical data. PLS and PCR chemometric assisted spectrophotometric techniques were also applied. The proposed methods are considered a green alternative to the reported methods as the greenness of the proposed methods was evaluated qualitatively and quantitatively by four green analytical evaluation tools.

Results:

The methods were applied for the analysis of the mixture in the pharmaceutical dosage form Triplixam and in vitro release at intestinal pH (7.4) using a USP dissolution tester.

Conclusions:

The proposed green analytical methods are considered to be greener than the reported methods and simpler, so they could be used as an alternative for routine analysis of the mixture in quality control laboratories for the reason of their accurate results beside minimum manipulation steps that reduced the error and time required of the analysis with no harmful effect on analyst health as well as the environment.

Highlights:

The study was the first in vitro dissolution profiling of perindopril, amlodipine, and indapamide. The developed methods were excellent green methods without compromising the analytical criteria.

01 Dec 2020·BMC ophthalmologyQ4 · MEDICINE

Acute bilateral myopia induced by Triplixam: a case report

Q4 · MEDICINE

ArticleOA

Author: Sirvydyte, Ginte ; Jaruseviciene, Ruta

Abstract:

Background:

Side effects of the systemic drugs used to treat eyes are not common. Triplixam is used to treat systemic hypertension and contains amlodipine, indapamide and perindopril arginine as active ingredients which might have induced the sudden myopia. The transient myopia with objective findings disappeared after the discontinuation of the drug.

Case presentation:

A 33-year-old male presented to the emergency department with a history of blurred vision in both eyes. Development of myopia, lens thickening, choroidal effusion and retinal striae at the macula with the increase in macular thickness was observed in both eyes. These symptoms cleared completely after the drug was discontinued. Myopisation could have been caused by lens thickening and changing its refractive index as a result of allergic or idiosyncratic reaction of the ciliary body. Retinal striae may be caused by the volume effect of the choroidal effusion.

Conclusion:

Our report describes the adverse effect of Triplixam, probably resulting from its ingredient indapamide. Although indapamide is a common drug used in the treatment of systemic hypertension, it is important for cardiologists, general practitioners and other physicians to be aware of the possible adverse effect of Triplixam.

01 Oct 2014·Revue medicale de Liege

[Fixed dose combination perindopril-indapamide-amlodipine (Triplixam) for the treatment of arterial hypertension].

Article

Author: Scheen, A J ; Krzesinski, J M ; Lancellotti, P

Triplixam is a fixed dose combination of three well known antihypertensive agents, with complementary activities, to control blood pressure in patients with arterial hypertension: perindopril, an angiotensin converting enzyme inhibitor, indapamide, a diuretic whith thiazide-like effects but also specific properties, and amlodipine, a long-acting calcium antagonist of the dihydropyridine family. The potential synergic action allows better control of blood pressure with once daily administration, while limiting the incidence of adverse events. Various presentations with different dosages are available to facilitate individualized therapy. Warnings and precautions for use of every molecule should of course be respected. Such a fixed dose combination should contribute to limit clinical inertia and to improve therapeutic compliance.

100 Deals associated with Perindopril Arginine/ Indapamide/Amlodipine

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Essential Hypertension	SG	Les Laboratoires Servier SAS	23 May 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESH2019	Not Applicable	Hypertension \| Chronic Kidney Diseases	60	Perindopril arginine/indapamide 2.5/0.625 mg	ippzwpzuis(jamwkaaubv) = yrwfpggkei cqcuwfljcp (vnxjcwzvst ) View more	Positive	01 Jul 2019
ESH2019	Not Applicable	Hypertension	35	Perindopril arginine/indapamide fixed-dose combination (Pa/I FC)	wbbrwbnjeu(qiurcylnap) = bvbmjthckm tpjhgqmthy (uozhtpmvyr ) View more	Positive	01 Jul 2019
FORSAGE (ESH2018)	Not Applicable	Obesity	1,963	Perindopril arginine/indapamide (Normal BMI < 25 kg/m2)	fccdpcfhrv(ibbhngmpwj) = highest values were observed in the group of obese patients pqkbslwkhf (xqvghoyxue ) View more	Positive	01 Jun 2018
FORSAGE (ESH2018)	Not Applicable	Obesity	1,963	Perindopril arginine/indapamide (Overweight with 25 < BMI < 30 kg/m2)		Positive	01 Jun 2018