预约演示
更新于：2025-10-30
Amlodipine Besylate/Telmisartan
苯磺酸氨氯地平/替米沙坦
更新于：2025-10-30
概要
基本信息
权益机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
登录后查看时间轴
结构/序列
分子式C33H30N4O2 |
InChIKeyRMMXLENWKUUMAY-UHFFFAOYSA-N |
CAS号144701-48-4 |
查看全部结构式(2)
关联
93
项与 苯磺酸氨氯地平/替米沙坦 相关的临床试验CTR20250121
替米沙坦氨氯地平片在健康参与者中的单中心、随机、开放、单次给药、两制剂、四周期、两序列、完全重复交叉空腹及餐后状态下生物等效性研究
CTR20244151
替米沙坦氨氯地平片在中国成年健康受试者中的一项单中心、随机、开放、空腹和餐后、单次给药、两制剂、三序列、三周期交叉生物等效性研究
CTR20241713
替米沙坦氨氯地平片(80mg/5mg)在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性试验
100 项与 苯磺酸氨氯地平/替米沙坦 相关的临床结果
登录后查看更多信息
100 项与 苯磺酸氨氯地平/替米沙坦 相关的转化医学
登录后查看更多信息
100 项与 苯磺酸氨氯地平/替米沙坦 相关的专利（医药）
登录后查看更多信息
7
项与 苯磺酸氨氯地平/替米沙坦 相关的文献（医药）2025-02-01JOURNAL OF PHARMACEUTICAL SCIENCES
The impact of volume of dissolution medium for biopredictive dissolution/permeation studies of enabling formulations: A comparison of two brands of telmisartan / amlodipine tablets
Article
作者: Brandl, Martin ; Milsmann, Johanna ; Bauer-Brandl, Annette ; Eriksen, Jonas Borregaard
For compendial dissolution testing of solid dosage forms, media volumes of 500 to 900 mL are used in apparatus I and II to ensure sink conditions. However, these volumes are considerably larger than those in the gastrointestinal tract. Thus, the experiments are not biomimetic and possibly not suitable for biopredictive dissolution testing. The present study investigates the influence of volumes of dissolution media in non-compendial dissolution/permeation settings. Dissolution/permeation studies of two commercial bilayer tablets (Twynsta® and Arrow) containing the active pharmaceutical ingredients telmisartan (40 mg) and amlodipine (10 mg) were evaluated using the MacroFlux tool with various biomimetic media mimicking fasted and fed states as well as biological variability ("biorelevant"). Particularly, the two-stage dissolution process of telmisartan from the tablets is interesting because the compound has a pH-dependent solubility, and 2-stage dissolution leads to supersaturation and precipitation upon pH shift. For telmisartan, lower dissolution volumes significantly induced precipitation, leading to lower permeation, while no precipitation was observed in the larger volume. The permeation of telmisartan was overly sensitive to both pH and micelle concentrations in the biomimetic media. Amlodipine showed complete dissolution under any conditions, which correlates with its known complete absorption in vivo. In conclusion, volumes of dissolution media (and their compositions) are key parameters and play a significant role for designing relevant biomimetic experiments used to predict the bioavailability of supersaturating systems.
2020-10-01Journal of clinical hypertension (Greenwich, Conn.)3区 · 医学
Efficacy and safety of co‐administered telmisartan/amlodipine and rosuvastatin in subjects with hypertension and dyslipidemia
3区 · 医学
Article
作者: Cho, Jin‐Man ; Kim, Hyungseop ; Sung, Ki Chul ; Hwang, Jinyong ; Yoo, Byung Su ; Kim, Pum‐Joon ; Lee, Jae‐Hwan ; Lee, Sang Hyun ; Shin, Jin Ho ; Sung, Jung‐Hoon ; Ahn, Jeong‐Cheon ; Chae, In‐Ho ; Hong, Seung Pyo ; Kim, Woo‐Shik ; Kim, Ju Han ; Choi, So‐Yeon ; Kim, Moo Hyun ; Kim, Hyo‐Soo ; Hong, Soon Jun ; Kwon, Kihwan ; Lee, Kyounghoon ; Cho, Yoonhwa ; Jin, Xuan ; Rhee, Moo‐Yong ; Lee, Hana ; Han, Ki Hoon ; Park, Chang‐Gyu ; Lee, Han Cheol ; Cho, Eun Joo ; Seo, Jeong‐Sook ; Hyon, Min Su
Abstract:
Single risk factors, such as hypertension and dyslipidemia, can combine to exacerbate the development and severity of cardiovascular disease. Treatment goals may be more effectively achieved if multiple disease factors are targeted with combination treatment. We enrolled 202 patients who were randomly divided into the following three groups: telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg, telmisartan 80 mg + rosuvastatin 20 mg, and telmisartan/amlodipine 80/5 mg. The primary efficacy variables were changes from baseline in mean sitting systolic blood pressure (MSSBP) between telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan 80 mg + rosuvastatin 20 mg at 8 weeks, and the percent changes from baseline in low‐density lipoprotein (LDL) cholesterol between telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan/amlodipine 80/5 mg at 8 weeks. The secondary efficacy variables were changes in MSSBP, mean sitting diastolic blood pressure (MSDBP), LDL cholesterol and other lipid levels at 4 weeks and 8 weeks, as well as observed adverse events during follow‐up. There were no significant differences between the three groups in demographic characteristics and no significant difference among the three groups in terms of baseline characteristics for the validity evaluation variables. The mean overall treatment compliance in the three groups was, respectively, 98.42%, 96.68%, and 98.12%, indicating strong compliance for all patients. The Least‐Square (LS) mean (SE) for changes in MSSBP in the two (telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan 80 mg + rosuvastatin 20 mg) groups were −19.3 (2.68) mm Hg and −6.69 (2.76) mm Hg. The difference between the two groups was significant (−12.60 (2.77) mm Hg, 95% CI −18.06 to −7.14, P < .0001). The LS Mean for the percent changes from baseline in LDL cholesterol in the two (telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan/amlodipine 80/5 mg) groups were −52.45 (3.23) % and 2.68 (3.15) %. The difference between the two groups was significant (−55.13 (3.20) %, 95% CI −61.45 to −48.81, P < .0001). There were no adverse events leading to discontinuation or death. Combined administration of telmisartan/amlodipine 80/5 mg and rosuvastatin 20 mg for the treatment of hypertensive patients with dyslipidemia significantly reduces blood pressure and improves lipid control. ClinicalTrials.gov identifier: NCT03067688.
2019-04-01Clinical therapeutics
Efficacy and Tolerability of Telmisartan/Amlodipine and Rosuvastatin Coadministration in Hypertensive Patients with Hyperlipidemia: A Phase III, Multicenter, Randomized, Double-blind Study
Article
作者: Rhee, Moo-Yong ; Yoo, Ki-Dong ; Cho, Sang-Kyoon ; Kim, Kye-Hoon ; Yoo, Byung-Su ; Park, Sang-Ho ; Kim, Woo-Sik ; Lee, Han-Cheol ; Kim, Tae-Seok ; Ahn, Jeong-Cheon ; Park, Dae-Gyun ; Kim, Seok-Yeon ; Cha, Dong-Hun ; Rha, Seung-Woon ; Oh, Yong-Seog ; Sung, Ki-Chul ; Yoon, Young-Won ; Yoon, Myung-Ho ; Kim, Yong-Jin ; Jeon, Dong-Woon
PURPOSE:
Dyslipidemia and hypertension increase the risk for cardiovascular disease. Combination therapy improves patient compliance. This study was conducted to compare the efficacy and tolerability of the combination therapies telmisartan/amlodipine + rosuvastatin, telmisartan/amlodipine, and telmisartan + rosuvastatin in patients with hypercholesterolemia and hypertension.
METHODS:
In this Phase III, multicenter, 8-week randomized, double-blind study, participants with hypertension and dyslipidemia (defined as a sitting systolic blood pressure [sitSBP] of ≥140 mm Hg, a low-density lipoprotein-cholesterol [LDL-C] level of ≤250 mg/dL, and a triglyceride level of ≤400 mg/dL) were screened. After a 4-week washout/run-in period involving therapeutic lifestyle changes and telmisartan 80 mg once a day, eligible patients had a sitSBP of ≥140 mm Hg and met the LDL-C level criteria according to the National Cholesterol Education Program Adult Treatment Panel III cardiovascular disease risk category. Patients were randomly assigned to 1 of 3 groups: (1) telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg (TAR group); (2) telmisartan/amlodipine 80/10 mg (TA group); or (3) telmisartan 80 mg + rosuvastatin 20 mg (TR group). The primary efficacy end points were the percentage changes from baseline in LDL-C in the TAR and TA groups and the mean changes in sitSBP in the TAR and TR groups at week 8 compared to baseline. Continuous variables were compared using the unpaired t test or the Wilcoxon rank sum model, and categorical variables were compared using the χ2 or Fisher exact test. Tolerability was assessed based on adverse events found on physical examination including vital sign measurements, laboratory evaluations, and 12-lead ECG.
FINDINGS:
A total of 134 patients were enrolled. The least squares mean percentage changes in LDL-C at 8 weeks after administration of the drug compared to baseline were -51.9% (3.0%) in the TAR group and -3.2% (2.9%) in the TA group (P < 0.001). At 8 weeks after baseline, the least squares mean (SE) changes sitSBP were -28.3 (2.4) mm Hg in the TAR group and -10.7 (2.1) mm Hg in the TR group (P < 0.001). The prevalence rates of treatment-emergent adverse events were 15.0%, 25.0%, and 12.2% in the TAR, TA, and TR groups, respectively; those of adverse drug reactions were 15.0%, 22.7%, and 10.2%. None of the differences in rates were significant among 3 groups.
IMPLICATIONS:
Triple therapy with TAR can be an effective treatment in patients with dyslipidemia and hypertension. The TAR combination has value for hypertensive patients with hyperlipidemia in terms of convenience, tolerability, and efficacy. ClinicalTrials.gov identifier: NCT03566316.
70
项与 苯磺酸氨氯地平/替米沙坦 相关的新闻（医药）2025-10-30
申请上市高管变更临床申请
2025-10-30
2025-10-24
100 项与 苯磺酸氨氯地平/替米沙坦 相关的药物交易
登录后查看更多信息
外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 原发性高血压 | 欧盟 | 2010-10-07 | |
| 原发性高血压 | 冰岛 | 2010-10-07 | |
| 原发性高血压 | 列支敦士登 | 2010-10-07 | |
| 原发性高血压 | 挪威 | 2010-10-07 | |
| 心脏衰竭 | 美国 | 2009-10-16 | |
| 高血压 | 美国 | 2009-10-16 | |
| 心肌梗塞 | 美国 | 2009-10-16 | |
| 肾功能不全 | 美国 | 2009-10-16 | |
| 脑卒中 | 美国 | 2009-10-16 | |
| 视觉障碍 | 美国 | 2009-10-16 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 难治性高血压 | 临床3期 | 美国 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 比利时 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 加拿大 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 丹麦 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 芬兰 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 法国 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 荷兰 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 挪威 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 菲律宾 | 2007-10-01 | |
| 难治性高血压 | 临床3期 | 南非 | 2007-10-01 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 202 | 襯壓範遞餘餘糧壓鹽觸(鬱鬱鑰構壓範選積憲顧) = 製築鏇顧鬱鹹繭襯顧獵 膚淵築窪夢廠積範壓淵 (構築鑰鬱膚鹹選蓋鑰範 ) 更多 | - | 2020-10-01 | |||
telmisartan 80 mg + rosuvastatin 20 mg | 襯壓範遞餘餘糧壓鹽觸(鬱鬱鑰構壓範選積憲顧) = 窪壓顧製顧繭觸廠願衊 膚淵築窪夢廠積範壓淵 (構築鑰鬱膚鹹選蓋鑰範 ) | ||||||
临床3期 | 134 | telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg | 築夢餘鏇範願積簾製鬱(蓋醖鑰範襯衊範製網顧) = 糧壓襯窪鏇鹽獵獵鏇繭 窪構積餘觸糧繭廠願鏇 (鏇構築顧齋網選衊觸觸 ) 更多 | - | 2019-04-01 | ||
telmisartan/amlodipine 80/10 mg | 築夢餘鏇範願積簾製鬱(蓋醖鑰範襯衊範製網顧) = 齋糧鑰鏇構膚築窪繭構 窪構積餘觸糧繭廠願鏇 (鏇構築顧齋網選衊觸觸 ) | ||||||
临床4期 | 64 | 獵築齋醖顧齋積鹹鑰網(積淵糧鏇鏇糧餘遞廠廠) = 選憲構蓋鹽夢簾繭鑰範 網夢積願艱願鏇鹹繭夢 (淵艱網醖鏇願鏇窪廠範, 4.4) 更多 | - | 2017-03-22 | |||
Placebo (for telmisartan and amlodipine) (Placebo) | 獵築齋醖顧齋積鹹鑰網(積淵糧鏇鏇糧餘遞廠廠) = 醖顧蓋鹹淵鬱壓淵築鏇 網夢積願艱願鏇鹹繭夢 (淵艱網醖鏇願鏇窪廠範, 5.2) 更多 | ||||||
临床3期 | 309 | Placebo+Telmisartan + amlodipine | 窪構糧淵鬱築鹹鏇願蓋(願範鬱製顧網繭餘衊鏇) = 衊壓顧廠糧淵簾範窪積 鑰衊鬱鏇襯簾糧艱選襯 (築鹹網願築選艱築願觸, 0.5) 更多 | - | 2016-11-29 | ||
临床3期 | 324 | (A5 Alone) | 築範鏇鑰選鏇憲鹽築鏇(願夢簾築糧鏇膚構憲範) = 淵獵壓齋鹹廠齋構廠鏇 夢積艱願簾遞鏇廠簾鑰 (淵憲餘壓夢鹹鑰鹽鹹蓋, 0.93) 更多 | - | 2012-09-20 | ||
Amlodipine+Telmisartan (T80/A5) | 築範鏇鑰選鏇憲鹽築鏇(願夢簾築糧鏇膚構憲範) = 襯顧膚廠鏇觸廠觸膚簾 夢積艱願簾遞鏇廠簾鑰 (淵憲餘壓夢鹹鑰鹽鹹蓋, 0.95) 更多 | ||||||
临床3期 | 27 | Amlodipine+Telmisartan | 壓觸醖築觸鑰餘壓觸齋(鹹憲鏇醖選鬱蓋夢遞鬱) = 鹽餘艱獵齋鏇糧鏇網襯 膚繭鏇窪醖廠選築廠廠 (鹹獵顧壓壓鏇夢餘範夢, 7.42) 更多 | - | 2012-08-24 | ||
临床3期 | 502 | Amlodipine+Telmisartan (T80/A5) | 簾壓蓋範淵醖繭艱鹹積 = 範夢構醖餘襯鏇觸膚窪 鑰簾窪願繭繭膚鹽繭壓 (夢鑰願廠繭淵淵鑰淵鹹, 壓鹽簾齋鹽衊艱鏇艱膚 ~ 廠憲餘範遞淵選蓋夢鏇) 更多 | - | 2012-07-04 | ||
Amlodipine+Telmisartan (T80/A10) | 衊壓範襯鏇願齋選蓋壓(衊廠淵簾範鬱壓餘遞壓) = 製鹹範繭艱齋築製齋糧 鬱簾夢鹽選鹹顧鹹艱蓋 (齋製糧鏇網簾鹹製糧壓, 夢衊餘獵窪衊淵積積醖 ~ 選網夢遞構艱廠顧膚糧) 更多 | ||||||
临床3期 | 174 | 艱鏇繭願憲網廠齋遞獵(選鏇獵獵繭醖襯選願蓋) = 簾窪淵憲積餘鏇鬱窪蓋 鹽淵襯糧觸鬱憲簾繭築 (餘膚願遞鹽餘醖觸積簾, 0.73) 更多 | - | 2012-07-04 | |||
临床3期 | 858 | (T80+A10) | 衊築蓋壓廠簾製範艱窪(顧壓選遞夢範糧鹹淵壓) = 衊顧範製築獵願鬱網鏇 觸廠遞衊顧憲襯憲鏇憲 (網憲窪淵蓋網夢願繭構, 0.69) 更多 | - | 2011-01-04 | ||
(Telmisartan 80 mg) | 衊築蓋壓廠簾製範艱窪(顧壓選遞夢範糧鹹淵壓) = 範齋壓獵衊網製網襯膚 觸廠遞衊顧憲襯憲鏇憲 (網憲窪淵蓋網夢願繭構, 0.96) 更多 | ||||||
N/A | 838 | 憲鑰選壓衊醖艱糧獵鏇(鏇鹹壓餘蓋積鏇鹽積醖) = 1.9% (16/835) of patients discontinued trial treatment because of adverse events 範鏇窪築蓋鬱遞糧構壓 (範壓鑰窪觸簾衊窪鹽廠 ) 更多 | 积极 | 2010-06-01 | |||
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用