苯磺酸氨氯地平/缬沙坦/氢氯噻嗪(Amlodipine besilate/valsartan/hydrochlorothiazide) - 药物靶点：AT1R x NCC x VDCCs_在研适应症：原发性高血压，高血压_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Amlodipine Besylate/Valsartan/Hydrochlorothiazide、Amlodipine besylate/valsartan/hydrochlorothiazide、Amlodipine/Valsartan/Hydrochlorothiazide

+ [4]

靶点

AT1R x NCC x VDCCs

作用方式

拮抗剂、抑制剂、阻滞剂

作用机制

AT1R拮抗剂(血管紧张素II-1型受体拮抗剂)、NCC抑制剂(噻嗪类敏感氯化钠协同转运蛋白抑制剂)、VDCCs阻滞剂(电压门控性钙通道复合体阻滞剂)

治疗领域

心血管疾病

在研适应症

原发性高血压高血压

非在研适应症-

原研机构

Novartis Pharma AG

在研机构

Novartis Europharm Ltd.

Novartis AG

Novartis Pharmaceuticals Corp.

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (2009-04-30),

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C57H68Cl2N10O15S3

InChIKeyDEUYZXPBTVNVGM-NNUMAELLSA-N

CAS号1315609-13-2

关联

6

项与苯磺酸氨氯地平/缬沙坦/氢氯噻嗪相关的临床试验

CTR20182354

/ Active, not recruiting临床3期

Aprocitentan 治疗难治性高血压（RHT）受试者的多中心、盲法、随机、平行组、 3 期研究

这项研究的目的是评价在难治性高血压患者中在其他抗高血压药物治疗的基础上添加新药Aprocitentan在的降血压作用以及这种作用的持久性。

开始日期2019-05-27

申办/合作机构

杭州泰格医药技术咨询有限公司

NCT02742467

/ Completed临床4期IIT

Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans

The creole study is a A Multi-centre, multinational, randomised single-blind, parallel group, three-armed superiority trial which is aimed at comparing the efficacy of three "free" combinations of two anti-hypertensive agents on 24 hour ambulatory systolic blood pressure (ASBP) in black African hypertensive patients.

开始日期2017-06-07

申办/合作机构

University of Abuja

[+7]

NCT00931710

/ Completed临床4期

A 12-week Multicenter, Randomized, Double-blind, Parallel-group, Active-control Study to Evaluate the Antihypertensive Efficacy and Safety of Valsartan/Amlodipine-based Regimen Versus a Losartan-based Regimen in Patients With Stage 2 Systolic Hypertension

This study will compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and less than 200 mmHg).

开始日期2009-07-01

申办/合作机构

Novartis AG

100 项与苯磺酸氨氯地平/缬沙坦/氢氯噻嗪相关的临床结果

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100 项与苯磺酸氨氯地平/缬沙坦/氢氯噻嗪相关的转化医学

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100 项与苯磺酸氨氯地平/缬沙坦/氢氯噻嗪相关的专利（医药）

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2

项与苯磺酸氨氯地平/缬沙坦/氢氯噻嗪相关的文献（医药）

2014-09-01·American Journal of Therapeutics

Azilsartan, Aliskiren, and Combination Antihypertensives Utilizing Renin–Angiotensin–Aldosterone System Antagonists

Review

作者: Aronow, Wilbert S ; Sankholkar, Kedar ; Lanier, Gregg

Health care providers managing hypertension (HTN) have a large selection of pharmacologic agents to choose from, including several different classes of drugs and many similar drugs within each class. Antagonism of the renin-angiotensin-aldosterone system has been shown to be very effective for HTN, especially in patients with cardiovascular disease, diabetes, and heart failure. Within this group, there have been 2 new agents recently introduced to the US market and approved by the Food and Drug Administration. It is important for the HTN specialist to be familiar with the merits of these 2 drugs: the angiotensin receptor blocker Edarbi (azilsartan) and the renin inhibitor Tekturna (aliskiren). Additionally, there have been several new, fixed-dose combination antihypertensives introduced to the market since 2006 that use a renin-angiotensin-aldosterone antagonist. Seven of these combine 2 drugs together in a single pill: Edarbyclor (azilsartan/chlorthalidone), Exforge (amlodipine/valsartan), Azor (olmesartan/amlodipine), Twynsta (amlodipine/telmisartan), Tekturna HCT [aliskiren/hydrochlorothiazide (HCTZ)], Valturna (aliskiren/valsartan), Tekamlo (aliskiren/amlodipine). Three triple-drug combination medications have also been introduced recently: Exforge HCT (amlodipine/valsartan/HCTZ), Tribenzor (olmesartan/amlodipine/HCTZ), and Amturnide (aliskiren/amlodipine/hydrocholorothiazide). This review will summarize the trial data and important pharmacologic merits of these 2 new renin-angiotensin-aldosterone antagonists and the advantages of initiating treatment with one of the new fixed-dose, combination drugs approved over the last 5 years.

Revue medicale de Liege

[Medication of the month. Exforge HCT: combination of amlodipine besylate, valsartan and hydrochlorothiazide in a single tablet].

Article

作者: Lancellotti, P

Because of the multifactorial nature of hypertension, most patients require combination therapy to achieve blood pressure control. Very often the antihypertensive regimen includes a renin-angiotensin system blocker, a calcium channel blocker, and a diuretic. Currently, several associations combining two antihypertensive agents with complementary mechanisms of action are available. These combination therapies are more efficient to control blood pressure through synergistic and additive effects, can reach target blood pressure more quickly, are likely to attenuate the side effects of each molecule, and could improve patient adherence. Exforge HCT is the first fixed-dose combination of three antihypertensive drugs including amlodipine besylate, valsartan and hydrochlorothiazide (HCTZ) in a single pill. The association of these three drugs improves, with an equal tolerance, blood pressure control compared to dual therapies (valsartan/HCTZ, amlodipine/valsartan, or HCTZ/amlodipine). This triple therapy attenuates the diuretic-induced hypokalemia. The benefits of triple therapy over dual therapy are observed regardless of age, sex, race, ethnicity, or baseline mean sitting systolic blood pressure. Exforge HCT is currently indicated for the treatment of essential hypertension, as replacement therapy for adult patients whose blood pressure is adequately controlled by the combination of amlodipine, valsartan and HCTZ.

2

项与苯磺酸氨氯地平/缬沙坦/氢氯噻嗪相关的新闻（医药）

2023-12-26

·蒲公英Ouryao

参比制剂目录（第74批）正式发布！

转自：国家药监局编辑：wangxinglai20042023年12月26日，国家药监局发布了第74批次仿制药一致性评价参比制剂目录，其中新增品种32个、变更及增加持证商品种28个。通知原文经国家药品监督管理局仿制药质量和疗效一致性评价专家委员会审核确定，现发布仿制药参比制剂目录（第七十四批）。涉及品种：替戈拉生片、维奈克拉片、拉替拉韦钾片、茚达格莫吸入粉雾剂（II）、复方肝素钠尿囊素凝胶、维生素B12注射液、盐酸沙丙蝶呤散剂、苯磺酸氨氯地平口服溶液、氨氯地平缬沙坦氢氯噻嗪片、缬沙坦口崩片、匹伐他汀钙口崩片、茚达特罗莫米松吸入粉雾剂（I）、二十碳五烯酸乙酯软胶囊、注射用两性霉素B脂质体、硝普钠注射液、米氮平片、呋喃妥因胶囊、阿莫西林克拉维酸钾干糖浆（14:1）等；仿制药参比制剂目录（第74批）（扫描二维码下载附件）仿制药参比制剂目录（第74批）

一致性评价

2023-07-18

·蒲公英Ouryao

参比制剂目录（第70批）正式发布！

‍转自：国家药监局编辑：wangxinglai20042023年07月17日，国家药监局发布了第70批次仿制药一致性评价参比制剂目录，其中新增品种21个、变更及增加持证商品种27个。通知原文经国家药品监督管理局仿制药质量和疗效一致性评价专家委员会审核确定，现发布仿制药参比制剂目录（第70批）。涉及品种：环硅酸锆钠散、硫酸瑞美吉泮口崩片、氨氯地平缬沙坦氢氯噻嗪片、奥氮平萨米多芬片、注射用替马西普、阿伐替尼片、福辛普利钠片、磷酸西格列汀片、对乙酰氨基酚泡腾片、盐酸左沙丁胺醇雾化吸入溶液、盐酸他喷他多缓释片、阿奇霉素滴眼液等；仿制药参比制剂目录（第70批）（扫描二维码下载附件）仿制药参比制剂目录（第70批）‍‍

一致性评价

100 项与苯磺酸氨氯地平/缬沙坦/氢氯噻嗪相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	C09DX01	-

研发状态

批准上市

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	冰岛	Novartis Europharm Ltd.	2009-10-15
原发性高血压	欧盟	Novartis Europharm Ltd.	2009-10-15
原发性高血压	挪威	Novartis Europharm Ltd.	2009-10-15
原发性高血压	列支敦士登	Novartis Europharm Ltd.	2009-10-15
高血压	美国	Novartis Pharmaceuticals Corp.	2009-04-30

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
高血压	临床3期	印度	Novartis AG	2007-09-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ESC2018	临床3期	水肿	2,268	Amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCTZ)	壓淵膚鹽範顧餘蓋製鬱(簾憲淵壓齋蓋壓構艱糧) = 襯繭顧艱範壓衊憲鬱夢醖選願壓顧簾淵蓋齋衊 (簾網憲鬱積夢鬱築築鏇 )	-	2018-08-26
				Valsartan/amlodipine (Val/Aml)	壓淵膚鹽範顧餘蓋製鬱(簾憲淵壓齋蓋壓構艱糧) = 餘壓齋憲鬱觸淵壓簾鏇醖選願壓顧簾淵蓋齋衊 (簾網憲鬱積夢鬱築築鏇 )
[PP.27.20] (ESH2016)	N/A	高血压	1,080	Amlodipine/valsartan/hydrochlorothiazide 5/160/12.5 mg	選範範鬱願餘築膚繭觸(憲鏇糧艱憲窪鏇壓築齋) = 選簾廠鑰範繭觸醖願簾範鬱築鏇願鏇製築鬱範 (選艱鹹獵鏇觸範簾鏇鏇 ) 更多	积极	2016-09-01
				Amlodipine/valsartan/hydrochlorothiazide 10/160/25 mg	構窪築築範繭獵簾夢鑰(艱憲衊淵顧窪艱遞繭餘) = 獵窪窪顧獵築餘鑰蓋夢壓憲膚築廠襯鏇製壓夢 (夢構築構廠獵餘願窪鬱 ) 更多
NCT00931710 (EXALT, CTgov)	临床4期	高血压	488	valsartan, amlodipine, HCTZ (Valsartan/Amlodipine/HCTZ)	獵夢鏇鹽廠鏇壓壓獵繭(遞築糧壓壓積願鬱蓋獵) = 廠夢憲遞觸淵顧齋壓餘範廠鑰獵網繭餘鏇鹹夢 (艱衊製顧鏇齋網製餘膚, 廠簾鑰窪鬱壓窪夢醖鹹 ~ 齋觸壓齋衊齋壓繭鑰廠) 更多	-	2011-02-04
				Losartan, HCTZ+HCTZ+valsartan, amlodipine (Losartan/HCTZ)	獵夢鏇鹽廠鏇壓壓獵繭(遞築糧壓壓積願鬱蓋獵) = 廠淵範顧壓衊製艱獵糧範廠鑰獵網繭餘鏇鹹夢 (艱衊製顧鏇齋網製餘膚, 鏇醖艱襯淵淵願憲窪網 ~ 壓壓築簾製鑰鑰淵壓襯) 更多