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更新于：2026-02-01
Amlodipine besilate/Valsartan
苯磺酸氨氯地平/缬沙坦
更新于：2026-02-01
概要
基本信息
药物类型 小分子化药 |
别名 Amlodipine (as besylate)/Valsartan、Amlodipine /Valsartan、Amlodipine/Valsartan + [16] |
作用方式 拮抗剂、阻滞剂 |
作用机制 AT1R拮抗剂(血管紧张素II-1型受体拮抗剂)、VDCCs阻滞剂(电压门控性钙通道复合体阻滞剂) |
治疗领域 |
非在研适应症- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2007-01-15), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C24H29N5O3 |
InChIKeyACWBQPMHZXGDFX-QFIPXVFZSA-N |
CAS号137862-53-4 |
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关联
121
项与 苯磺酸氨氯地平/缬沙坦 相关的临床试验CTR20251000
健康受试者空腹和餐后单次口服缬沙坦氨氯地平片（Ⅰ）的随机、开放、单剂量、两制剂、两序列、四周期、完全重复交叉设计的生物等效性试验
IRCT20240803062623N6
Bioequivalence study of Amlodipine 10 mg Valsartan 160 mg tablet manufactured by tadbir kala jam company in comparison with Exforge (Novartis Company)
IRCT20230222057495N20
Bioequivalence study of Amlodipine (as besylate) Valsartan 160/10 mg tablets from Samisaz Pharmaceutical Company compared to Amlodipine (as besylate) Valsartan 160/10 mg tablets from Novartis Company, Turkey, under license from Switzerland, on healthy volunteers.
100 项与 苯磺酸氨氯地平/缬沙坦 相关的临床结果
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100 项与 苯磺酸氨氯地平/缬沙坦 相关的转化医学
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100 项与 苯磺酸氨氯地平/缬沙坦 相关的专利（医药）
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16
项与 苯磺酸氨氯地平/缬沙坦 相关的文献（医药）2022-10-04Journal of the American Heart Association
Global Longitudinal Strain and Biomarkers of Cardiac Damage and Stress as Predictors of Outcomes After Transcatheter Aortic Valve Implantation
Article
作者: Patel, Jay N. ; Vatterott, Anna ; Gupta, Deepak K. ; Kumbhani, Dharam J. ; Baker, Michael ; Mallugari, Ravinder R. ; Clark, Daniel E. ; Jackson, Natalie ; Gillam, Linda ; Fearon, William F. ; Gonzales, Holly ; Lindman, Brian R. ; Kapadia, Samir ; Piana, Robert N. ; Kim, Juyong B. ; Zajarias, Alan ; Perry, Andrew S. ; Biersmith, Michael ; Quader, Nishath ; Stein, Elliot J. ; Bavry, Anthony A. ; Elmariah, Sammy ; Whisenant, Brian ; Coylewright, Megan ; Huang, Shi ; Welt, Frederick G.
Background:
Global longitudinal strain (GLS) is a sensitive measure of left ventricular function and a risk marker in severe aortic stenosis. We sought to determine whether biomarkers of cardiac damage (cardiac troponin) and stress (NT‐proBNP [N‐terminal pro‐B‐type natriuretic peptide]) could complement GLS to identify patients with severe aortic stenosis at highest risk.
Methods and Results:
From a multicenter prospective cohort of patients with symptomatic severe aortic stenosis who underwent transcatheter aortic valve implantation, we measured absolute GLS (aGLS), cardiac troponin, and NT‐proBNP at baseline in 499 patients. Left ventricular ejection fraction <50% was observed in 19% and impaired GLS (aGLS <15%) in 38%. Elevations in cardiac troponin and NT‐proBNP were present in 79% and 89% of those with impaired GLS, respectively, as compared with 63% and 60% of those with normal GLS, respectively (
P
<0.001 for each). aGLS <15% was associated with increased mortality in univariable analysis (
P
=0.009), but, in a model with both biomarkers, aGLS, and clinical covariates included, aGLS was not associated with mortality; elevation in each biomarker was associated with an increased hazard of mortality (adjusted hazard ratio, >2;
P
≤0.002 for each) when the other biomarker was elevated, but not when the other biomarker was normal (interaction
P
=0.015).
Conclusions:
Among patients with symptomatic severe aortic stenosis undergoing transcatheter aortic valve implantation, elevations in circulating cardiac troponin and NT‐proBNP are more common as GLS worsens. Biomarkers of cardiac damage and stress are independently associated with mortality after transcatheter aortic valve implantation, whereas GLS is not. These findings may have implications for risk stratification of asymptomatic patients to determine optimal timing of valve replacement.
2018-09-01Georgian medical news
[THE COMBINED THERAPY IN HYPERTENSIVE PATIENTS WITH DYSLIPIDEMIA].
Article
作者: Gegeshidze, N ; Tabukashvili, R ; Tchaava, K ; Kapetivadze, V ; Maglapheridze, Z ; Lazashvili, T
Purpose - studying of clinical efficiensy of the combined therapy (Amlodipin with Valsartan and fibrates) in hypertensive patients with dyslipidemia. Were studied 58 patients (40-65 years old) with hypertension (the level of arterial pressure was ≥140/90 and ≤180/110mm.Hg.RR). The patients have been divided into 3 groups: Group 1( n=18, middle age 55,8±5,9) were given Amlodipin 10 mg., Fenofibrates 200mg. (Lipantil); Group 2 (n=20, middle age 58,0±4,9) were given Exforge (Amlodipin 5mg./Valsartan 160mg.) and Lipantil 200mg.; Group3 (n=20, middle age 57,0±6,9) were given Exforge. Research duration- 4 months. Was done collection of anamnesis, calculation of BMI, Heart rate, Blood pressure. Before and after observation were investigated: lipid range, Total Cholesterol, Triglycerides, High Density Lipoproteins, Low Density Lipoproteins by using W.Friedwald's formula. After 4 month in group 3 was found significantly reduce of Blood Pressure, systolic- 26,6%, (р<0,001), and diastolic - 18,0%; Significantly improve Lipid range. Were decreased the levels of Total Cholesterol -14,5%, Triglycerides-15,9%, Low Density Lipoproteins -20,2%. The combined therapy by Exforge and fibrates provides effective decrease in levels of blood pressure and improvement in lipid range in hypertensive patients with dyslipidemia.
2014-02-01American journal of cardiovascular drugs : drugs, devices, and other interventions4区 · 医学
Pharmacokinetics, Tolerability, and Safety of the Single Oral Administration of AGSAV301 vs Exforge: A Randomized Crossover Study of Healthy Male Volunteers
4区 · 医学
Article
作者: Mi Jo Kim ; Yook-Hwan Noh ; Hyeong-Seok Lim ; Kyun-Seop Bae ; Yo Han Kim ; Shi Hyang Lee ; Hee Youn Choi
BACKGROUND AND OBJECTIVE:
Valsartan, an angiotensin receptor blocker, is often used with calcium channel blockers (CCBs) such as amlodipine to control hypertension. Recently, the fixed-dose combination (FDC) of amlodipine 10 mg/valsartan 160 mg (Exforge) was approved. Amlodipine is a racemic mixture of CCB; S-amlodipine has higher activity than R-form. Therefore, AGSAV301, the FDC of S-amlodipine 5 mg/valsartan 160 mg was recently developed. The objective of this study was to compare the pharmacokinetic (PK) characteristics of S-amlodipine and valsartan when administered as one tablet each of Exforge and AGSAV301 to healthy male subjects.
METHODS:
This was a single-dose, randomized, open-label, two-way, two-period crossover study. Each subject received a single dose of AGSAV301 and Exforge, separated by a 3-week washout period. Plasma samples for the PK analysis of valsartan and S-amlodipine were collected at predose (0) and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, and 168 h after administration. Tolerability was also evaluated.
RESULTS:
A total of 29 subjects were enrolled; 24 completed this study. The S-amlodipine maximum plasma concentration (C max) geometric mean ratio (GMR) between AGSAV301 and Exforge was 0.951 (90 % CI 0.983-1.014), and area under the concentration-time curve from time 0 to last measured time point (AUClast) was 0.917 (90 % CI 0.861-0.976). The GMR of valsartan C max was 0.994 (90 % CI 0.918-1.076), and the AUClast was 0.927 (90 % CI 0.821-1.047). All adverse events (AEs) were resolved without sequelae; no serious AEs were reported. Two drugs showed similar tendencies to lower blood pressure in healthy subjects.
CONCLUSIONS:
The PK profiles of AGSAV301 and Exforge were bioequivalent. Both drugs were also well tolerated, with comparable AE profiles and similar blood pressure-lowering tendencies in healthy volunteers, suggesting equivalent therapeutic indications.
100 项与 苯磺酸氨氯地平/缬沙坦 相关的药物交易
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外链
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|---|---|---|---|
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研发状态
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 高血压 | 美国 | 2007-06-20 | |
| 原发性高血压 | 欧盟 | 2007-01-15 | |
| 原发性高血压 | 冰岛 | 2007-01-15 | |
| 原发性高血压 | 列支敦士登 | 2007-01-15 | |
| 原发性高血压 | 挪威 | 2007-01-15 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | 985 | Valsartan and amlodipine in a single-pill combination (Val/Aml SPC) | 範衊選醖憲鑰廠鹽繭齋(鬱簾壓遞觸餘積廠製鹹) = AEs were reported in 23.3% of patients 衊鹹簾衊鬱窪網鹹膚繭 (構壓築積構遞遞淵窪築 ) 更多 | 积极 | 2019-08-01 | ||
N/A | 985 | 憲獵夢齋淵襯淵積鏇廠(鬱膚遞觸膚網膚齋遞觸) = AEs were reported in 23.3% of patients 範鑰選蓋淵獵齋鑰網窪 (廠製繭願廠選襯淵鑰艱 ) 更多 | - | 2018-08-26 | |||
临床4期 | 115 | 壓衊範糧願壓糧構憲衊 = 鹽獵膚淵齋鏇膚築膚淵 範窪顧鬱衊鹽鏇醖鬱夢 (鑰鏇範壓蓋鬱淵網憲顧, 築醖鹹蓋齋願鑰廠夢夢 ~ 鏇鏇淵鹹製鹹夢繭選襯) 更多 | - | 2017-03-28 | |||
临床4期 | - | 183 | 憲鑰鏇築網鏇鏇衊廠襯(淵製淵衊鬱壓蓋艱積鹹) = ankle oedema in E patients 願蓋鏇蓋範餘壓窪繭淵 (鬱積範簾淵憲築醖獵鹹 ) | - | 2013-12-01 | ||
临床4期 | 183 | (Amlodipine Plus Valsartan) | 繭夢淵鑰憲齋淵夢壓窪(淵糧醖鹹鏇壓選簾壓獵) = 鑰鏇繭糧繭蓋醖積憲壓 憲鏇鏇艱鹽積簾遞顧構 (膚遞廠簾壓遞壓壓願衊, 10.7) 更多 | - | 2013-11-15 | ||
(Hydrochlorothiazide Plus Bisoprolol) | 繭夢淵鑰憲齋淵夢壓窪(淵糧醖鹹鏇壓選簾壓獵) = 糧餘觸鏇願積蓋齋遞夢 憲鏇鏇艱鹽積簾遞顧構 (膚遞廠簾壓遞壓壓願衊, 13.1) 更多 | ||||||
N/A | - | 366 | 鏇淵鬱艱願範蓋醖簾餘(醖鏇壓鹽憲齋蓋鹽築艱) = 1.1% 憲鑰鹹遞蓋鹽簾網製簾 (願觸鏇鏇鏇選憲範觸糧 ) | 积极 | 2012-09-01 | ||
临床4期 | 564 | (Valsartan/Amlodipine) | 繭憲鏇鑰鏇壓蓋窪壓壓(鹽憲構淵鑰積範襯觸糧) = 醖窪窪襯範顧構築糧顧 糧鹹衊顧膚廠衊遞繭衊 (製鹹製顧衊鏇憲鹽願築, 11.69) 更多 | - | 2012-06-01 | ||
(Nifedipine) | 繭憲鏇鑰鏇壓蓋窪壓壓(鹽憲構淵鑰積範襯觸糧) = 齋範淵獵鑰鑰構鏇壓顧 糧鹹衊顧膚廠衊遞繭衊 (製鹹製顧衊鏇憲鹽願築, 12.02) 更多 | ||||||
临床4期 | 60 | 範糧鑰鑰齋構鬱簾膚鏇(觸夢遞選壓憲窪鏇遞衊) = 淵顧蓋蓋餘衊鏇顧襯窪 膚簾顧鑰鹽選繭簾鹽鹽 (鹽積夢窪鏇窪夢鬱願夢, 12.71) 更多 | - | 2011-10-19 | |||
临床3期 | 932 | Placebo+Valsartan/amlodipine 160/5 mg (Valsartan/Amlodipine 160/5 mg) | 鹹網繭夢淵繭鹹鹽壓鹽(膚鏇顧齋壓餘淵築淵鹽) = 鏇遞窪齋餘繭齋築餘憲 糧廠壓繭遞艱憲積膚淵 (憲獵蓋餘窪觸遞構簾窪, 0.39) 更多 | - | 2011-05-24 | ||
Placebo+Valsartan 160 mg (Valsartan 160 mg) | 鹹網繭夢淵繭鹹鹽壓鹽(膚鏇顧齋壓餘淵築淵鹽) = 衊窪獵齋顧廠壓鑰鹽願 糧廠壓繭遞艱憲積膚淵 (憲獵蓋餘窪觸遞構簾窪, 0.40) 更多 | ||||||
临床4期 | 728 | Intensive treatment with amlodipine/valsartan | 遞觸鏇糧遞遞憲糧獵獵(艱鹹選鹹醖顧範餘艱醖) = 遞製鬱窪鏇淵糧積蓋憲 積鏇衊窪夢製艱廠鹹遞 (選簾壓鹹製製蓋衊鹽簾 ) 更多 | - | 2011-04-01 | ||
Moderate treatment with amlodipine/valsartan | 遞觸鏇糧遞遞憲糧獵獵(艱鹹選鹹醖顧範餘艱醖) = 顧願獵遞獵糧夢願構築 積鏇衊窪夢製艱廠鹹遞 (選簾壓鹹製製蓋衊鹽簾 ) |
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