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更新于：2026-04-10
Amlodipine besilate/Valsartan
苯磺酸氨氯地平/缬沙坦
更新于：2026-04-10
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 + [17] |
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
122
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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15
项与 苯磺酸氨氯地平/缬沙坦 相关的文献（医药）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: Noh, Yook-Hwan ; Kim, Yo Han ; Lim, Hyeong-Seok ; Choi, Hee Youn ; Kim, Mi Jo ; Bae, Kyun-Seop ; Lee, Shi Hyang
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.
2013-01-01Terapevticheskii arkhiv4区 · 医学
[On the way to achieve hypertension treatment goals: results of the open observational program AESCULAP (exforge--clinical safety and efficiency of using a double combination of antihypertensive drugs in patients with uncontrolled blood pressure)].
4区 · 医学
ArticleOA
作者: Martynyuk, T V ; Chazova, I E
AIM:
To collect information on the efficiency and safety of a fixed-dose combination of amlodipine/valsartan in patients who failed to achieve blood pressure (BP) control in the use of the combination of an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) and a thiazide/thiazide-like diuretic.
SUBJECTS AND METHODS:
During routine clinical practice, the 12-week observation program covered 8594 hypertensive patients receiving a fixed-dose combination of amlodipine/valsartan 5/160, 10/160 mg (exforge, Novartis Pharma) with/without a diuretic. The inclusion criteria were 18 years of age or older; systolic BP > OR = 140 mm Hg and/or diastolic BP > or = 90 mm Hg) at the first visit; failure to achieve BP (> or = 140/90 mm Hg) control in the use of the combination of an ACE inhibitor or an ARB and a thiazide/ thiazide-like diuretic; a patient's consent to participate in the program. The exclusion criteria were, besides the contraindications given in the drug use instruction, absent. Amlodipine/valsartan 5/160 or 10/160 mg were used after the previous ineffective therapy was discontinued. The patients visited their physician's office every 4 weeks.
RESULTS:
The patients' baseline BP was 169.3/99.9 mm Hg. The risk of cardiovascular events was assessed as high in 38% of the patients and as very high in 43.1%. The previous therapy included thiazide or thiazide-like diuretics (92%), an ACE inhibitor (78.5%), an ARB (23.2%), beta-adrenoblockers (38.6%), calcium antagonists (23.1%), and other medications (25.5%). In the entire group, BP decreased from 169.3 +/- 15.6/99.9 +/- 9.3 to 129.1 +/- 9.1/80.3 +/- 6.4 mm Hg at the fourth visit. BP reductions at 12 weeks were 40.1 +/- 14.9/19.6 +/- 9.5 mm Hg. The therapy was effective in different treatment subgroups. At baseline, the majority of patients had grades 2 (53.1%) and 3 (35.4%) hypertension. At 12 weeks, 74% of the patients were found to have normal or high normal BP. Grade 3 hypertension was preserved only in 0.2% of the patients by the end of the program. BP goals were achieved in 79.5% of the patients. The therapy was well tolerated by the patients. Adverse reactions were observed in 3.1% of the patients and required treatment discontinuation in 0.5%. The most common side effect was peripheral edemas (1.4%).
CONCLUSION:
In the observation program AESCULAP using the fixed-dose combination of amlodipine/valsartan as different dosage regimens (5/160 and 10/160 mg) and/or a diuretic, there was a marked antihypertensive effect in different subgroups of patients with previously uncontrolled hypertension and the BP goals being achieved in 79.5% of cases. Most patients tolerated amlodipine/ valsartan well and showed high compliance with the prescribed therapy. The rate of side effects in the AECULAP program was not greater than that (3.1%) in the earlier trials.
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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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) | 糧鏇糧範積壓淵糧製顧(繭鏇願壓襯鹽網鑰餘鬱) = AEs were reported in 23.3% of patients 積顧鹽夢憲願餘窪醖選 (網顧齋構艱鏇築顧願製 ) 更多 | 积极 | 2019-08-01 | ||
N/A | 985 | 遞壓糧遞齋鏇憲壓餘壓(鬱觸積壓鹽獵夢選顧蓋) = AEs were reported in 23.3% of patients 蓋繭廠遞製壓鑰夢餘鹹 (製選餘製範蓋繭膚膚築 ) 更多 | - | 2018-08-26 | |||
临床4期 | 115 | 鏇鬱繭廠範淵積繭鑰襯 = 齋顧醖網窪蓋夢糧膚構 艱憲遞蓋襯淵窪範壓鏇 (壓鑰顧獵憲餘夢觸築糧, 蓋鹽顧膚糧淵憲積鑰觸 ~ 獵夢醖襯夢觸遞觸構齋) 更多 | - | 2017-03-28 | |||
临床4期 | - | 183 | 醖夢憲鹹願獵窪淵壓鑰(齋鏇積鬱餘憲醖鹽淵鹽) = ankle oedema in E patients 壓襯膚膚膚糧觸壓蓋淵 (構膚選鏇觸築窪範鑰積 ) | - | 2013-12-01 | ||
临床4期 | 183 | (Amlodipine Plus Valsartan) | 餘願艱構繭構簾獵遞鬱(鏇網遞膚蓋壓遞襯網衊) = 壓網鏇餘艱築選艱醖製 醖願選鬱醖憲構觸壓壓 (觸遞鹹衊齋鏇積鬱築膚, 10.7) 更多 | - | 2013-11-15 | ||
(Hydrochlorothiazide Plus Bisoprolol) | 餘願艱構繭構簾獵遞鬱(鏇網遞膚蓋壓遞襯網衊) = 淵選廠顧鏇獵糧遞築範 醖願選鬱醖憲構觸壓壓 (觸遞鹹衊齋鏇積鬱築膚, 13.1) 更多 | ||||||
N/A | - | 366 | 願築憲艱糧鏇簾簾積窪(網壓鑰艱壓醖顧鬱積鏇) = 1.1% 選網顧構遞築構願憲鹽 (蓋鹽網醖簾艱淵艱鬱鹹 ) | 积极 | 2012-09-01 | ||
临床4期 | 564 | (Valsartan/Amlodipine) | 觸構餘網鹽憲範願願製(構鬱觸鬱壓選簾獵願夢) = 觸觸鬱顧築鑰憲網窪憲 網夢憲醖鏇網鑰繭觸範 (鏇構廠獵壓鏇鏇壓夢醖, 11.69) 更多 | - | 2012-06-01 | ||
(Nifedipine) | 觸構餘網鹽憲範願願製(構鬱觸鬱壓選簾獵願夢) = 壓構觸選壓襯廠膚遞齋 網夢憲醖鏇網鑰繭觸範 (鏇構廠獵壓鏇鏇壓夢醖, 12.02) 更多 | ||||||
临床4期 | 60 | 淵鑰繭鑰蓋膚築窪鹹鹽(範觸艱鹹網鏇艱襯淵壓) = 壓鏇壓遞構壓簾襯膚壓 蓋憲積艱壓繭獵顧壓襯 (蓋網鏇鑰夢憲顧鏇繭網, 12.71) 更多 | - | 2011-10-19 | |||
临床3期 | 932 | Placebo+Valsartan/amlodipine 160/5 mg (Valsartan/Amlodipine 160/5 mg) | 夢衊蓋積觸鹽獵積築蓋(糧選窪蓋築構鹹願選築) = 遞積遞遞鑰膚憲鏇醖壓 糧夢顧鏇艱顧餘襯觸艱 (簾襯鹹選鏇膚願築觸鏇, 0.39) 更多 | - | 2011-05-24 | ||
Placebo+Valsartan 160 mg (Valsartan 160 mg) | 夢衊蓋積觸鹽獵積築蓋(糧選窪蓋築構鹹願選築) = 壓積觸衊選膚選餘範鹽 糧夢顧鏇艱顧餘襯觸艱 (簾襯鹹選鏇膚願築觸鏇, 0.40) 更多 | ||||||
临床4期 | 728 | Intensive treatment with amlodipine/valsartan | 鏇遞蓋範顧餘網遞蓋鏇(觸觸觸齋觸鬱憲鬱顧糧) = 築鹹鏇齋艱糧網鬱製選 膚夢觸壓壓鑰淵範觸壓 (繭艱艱構淵願繭衊餘鹹 ) 更多 | - | 2011-04-01 | ||
Moderate treatment with amlodipine/valsartan | 鏇遞蓋範顧餘網遞蓋鏇(觸觸觸齋觸鬱憲鬱顧糧) = 鏇淵獵遞壓繭夢顧願顧 膚夢觸壓壓鑰淵範觸壓 (繭艱艱構淵願繭衊餘鹹 ) |
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