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

Triplixam

靶点

ACE x VDCCs

作用方式

抑制剂、阻滞剂

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/序列

分子式C25H46N6O7

InChIKeyRYCSJJXKEWBUTI-YDYAIEMNSA-N

CAS号612548-45-5

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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-

NCT05470764

/ Completed临床1期

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.

开始日期2021-05-30

申办/合作机构

Darnitsa Pharmaceutical Co.

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

AbstractBackgroundTriplixam® is a new antihypertensive drug combination consisting of perindopril, amlodipine, and indapamide, which have a synergistic mechanism of action in combination with each other.ObjectiveComparative study of different spectrophotometric approaches used for the simultaneous determination of perindopril, indapamide, and amlodipine in bulk powder and in dosage form Triplixam.MethodThe 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.ResultsThe 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.ConclusionsThe 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.HighlightsThe 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: Jaruseviciene, Ruta ; Sirvydyte, Ginte

AbstractBackgroundSide 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 presentationA 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.ConclusionOur 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

Combinaison fixe périndopril-indapamide-amlodipine (Triplixam) pour le traitement de l'hypertension artérielle.

Article

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

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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研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
原发性高血压	新加坡	Les Laboratoires Servier SAS	2016-05-23

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


FORSAGE (ESH2018)	N/A	肥胖	1,963	Perindopril arginine/indapamide (Normal BMI < 25 kg/m2)	(築艱網構鏇鹹夢壓鹽構) = highest values were observed in the group of obese patients 窪積願襯獵艱獵觸衊壓 (淵憲鑰遞繭廠鑰顧壓壓 ) 更多	积极	2018-06-01
				Perindopril arginine/indapamide (Overweight with 25 < BMI < 30 kg/m2)
PERFORMANCE study (ESH2017)	N/A	糖尿病 \| 高血压	251	Perindopril arginine 10 mg/Indapamide 2.5 mg	觸顧醖鬱鏇蓋積築簾衊(蓋鬱窪夢顧鹽鑰糧艱鹹) = 蓋廠顧憲憲齋鑰觸蓋鏇選遞遞顧獵鹽艱鹹夢觸 (鹹觸糧鑰顧憲積糧遞餘 ) 更多	积极	2017-09-01
PERFORMANCE study (ESH2017)	N/A	糖尿病 \| 高血压	2,746	Perindopril arginine 10 mg/Indapamide 2.5 mg	夢齋糧鹹餘鹹遞壓糧顧(衊鬱鏇簾窪網範網鏇衊) = 積選鹹繭網鹹鹽壓鏇顧壓夢鑰夢廠鏇餘鑰艱襯 (襯衊鑰鏇鹹鑰壓鹹鹹鬱 ) 更多	积极	2017-09-01
PP.21.07 (ESH2015)	N/A	高血压	-	Triplixam® 5/1.25/5 mg	範壓夢積網鏇壓壓鏇壓(鑰蓋憲衊製夢顧製壓製) = An adverse event occurred in 1 patient from the initial group - mild edema of the lower limbs 繭蓋獵醖餘觸餘壓淵糧 (夢製構築獵構鹽蓋蓋襯 )	积极	2015-06-01
				Triplixam® 10/2.5/10 mg