精氨酸培哚普利/吲达帕胺/氨氯地平(Perindopril Arginine/ Indapamide/Amlodipine) - 药物靶点：ACE x VDCCs_在研适应症：原发性高血压_专利_临床

概要

基本信息

药物类型

小分子化药

别名

S06593、Triplixam

靶点

ACE x VDCCs

作用机制

ACE抑制剂(血管紧张素转化酶抑制剂)、VDCCs阻滞剂(电压门控性钙通道复合体阻滞剂)、协同转运子抑制剂

治疗领域

心血管疾病

在研适应症

原发性高血压

非在研适应症-

原研机构

Les Laboratoires Servier SAS

在研机构

Les Laboratoires Servier SAS

非在研机构-

最高研发阶段批准上市

首次获批日期

新加坡 (2016-05-23),

原发性高血压

最高研发阶段(中国)-

特殊审评-

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结构

分子式C20H25ClN2O5

InChIKeyHTIQEAQVCYTUBX-UHFFFAOYSA-N

CAS号88150-42-9

查看全部结构式(3)

关联

4

项与精氨酸培哚普利/吲达帕胺/氨氯地平相关的临床试验

NCT06259175 / Not yet recruitingN/A

Evaluation of the Antihypertensive effectIveness, Tolerability, and Adherence With Amlodipine/ Indapamide/ Perindopril Triple Single-pill Combination in Hypertensive Patients Without Concomitant Antihypertensive Therapy (TRIPTYCH)

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.

开始日期2024-05-01

申办/合作机构

Servier Russia

NCT06275763 / Recruiting临床4期IIT

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

开始日期2023-10-20

申办/合作机构-

NCT05940909 / Recruiting临床1期

Open-label Randomized Crossover Two Period Single Dose Bioequivalence Study of Two Formulations of Perindopril Erbumine/Indapamide/Amlodipine 8 mg/2.5 mg/10 mg Tablets (Pharmtechnology LLC, Republic of Belarus) and Triplixam® 10 mg/2.5 mg/10 mg Tablets (Les Laboratoires Servier Industrie, France) in Healthy Volunteers Under Fasting Conditions

This is an open-labeled, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Triplixam®, 10 mg/2.5 mg/10 mg tablets) or the test (Perindopril Erbumine/ 8 mg/2.5 mg/10 mg Tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.

开始日期2023-06-24

申办/合作机构

Pharmtechnology, LLC

100 项与精氨酸培哚普利/吲达帕胺/氨氯地平相关的临床结果

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100 项与精氨酸培哚普利/吲达帕胺/氨氯地平相关的转化医学

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100 项与精氨酸培哚普利/吲达帕胺/氨氯地平相关的专利（医药）

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6

项与精氨酸培哚普利/吲达帕胺/氨氯地平相关的文献（医药）

2023-05-03·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

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

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.

2020-12-01·BMC ophthalmology4区 · 医学

Acute bilateral myopia induced by Triplixam: a case report

4区 · 医学

ArticleOA

作者: 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.

2014-10-01·Revue medicale de Liege

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

Article

作者: 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 项与精氨酸培哚普利/吲达帕胺/氨氯地平相关的药物交易

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