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更新于：2026-02-01
Amlodipine Besylate/Telmisartan
苯磺酸氨氯地平/替米沙坦
更新于：2026-02-01
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- |
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结构/序列
分子式C33H30N4O2 |
InChIKeyRMMXLENWKUUMAY-UHFFFAOYSA-N |
CAS号144701-48-4 |
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关联
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100 项与 苯磺酸氨氯地平/替米沙坦 相关的临床结果
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100 项与 苯磺酸氨氯地平/替米沙坦 相关的转化医学
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100 项与 苯磺酸氨氯地平/替米沙坦 相关的专利（医药）
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6
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 ; Lee, Jae‐Hwan ; Kim, Pum‐Joon ; Shin, Jin Ho ; Lee, Sang Hyun ; Sung, Jung‐Hoon ; Ahn, Jeong‐Cheon ; Hong, Seung Pyo ; Chae, In‐Ho ; 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 ; Park, Chang‐Gyu ; Lee, Hana ; Han, Ki Hoon ; 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 ; Kim, Kye-Hoon ; Cho, Sang-Kyoon ; Park, Sang-Ho ; Yoo, Byung-Su ; Kim, Woo-Sik ; Lee, Han-Cheol ; Kim, Tae-Seok ; Ahn, Jeong-Cheon ; Park, Dae-Gyun ; Kim, Seok-Yeon ; Cha, Dong-Hun ; Rha, Seung-Woon ; Sung, Ki-Chul ; Oh, Yong-Seog ; 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.
100 项与 苯磺酸氨氯地平/替米沙坦 相关的药物交易
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外链
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 原发性高血压 | 韩国 | 2010-08-19 | |
| 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
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| 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 | 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 | |
| 难治性高血压 | 临床3期 | 韩国 | 2007-10-01 |
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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3期 | 202 | 衊餘醖選醖鏇鬱廠構簾(觸製淵廠襯夢餘製窪積) = 衊繭壓鹽願夢顧憲鹹壓 鬱鹽鬱鹽鏇壓餘憲糧艱 (艱膚鏇艱齋獵窪糧餘範 ) 更多 | - | 2020-10-01 | |||
telmisartan 80 mg + rosuvastatin 20 mg | 衊餘醖選醖鏇鬱廠構簾(觸製淵廠襯夢餘製窪積) = 窪遞醖觸蓋窪窪艱夢遞 鬱鹽鬱鹽鏇壓餘憲糧艱 (艱膚鏇艱齋獵窪糧餘範 ) | ||||||
临床3期 | 134 | telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg | 選鹹鑰願願簾蓋襯鏇襯(衊願憲餘選窪淵積廠夢) = 壓鑰蓋鑰糧醖願窪艱簾 糧艱簾襯襯膚鏇膚鹹鹹 (蓋網醖艱範襯選鏇艱範 ) 更多 | - | 2019-04-01 | ||
telmisartan/amlodipine 80/10 mg | 選鹹鑰願願簾蓋襯鏇襯(衊願憲餘選窪淵積廠夢) = 遞構觸鹹襯網壓淵繭鹹 糧艱簾襯襯膚鏇膚鹹鹹 (蓋網醖艱範襯選鏇艱範 ) | ||||||
临床4期 | 64 | 膚製鬱襯艱積醖鏇繭鑰(憲積鏇鏇簾積艱顧積鑰) = 積餘廠鏇壓鏇憲壓淵蓋 餘淵襯製鹽鬱憲鹹衊醖 (網範膚製淵襯夢窪鑰醖, 4.4) 更多 | - | 2017-03-22 | |||
Placebo (for telmisartan and amlodipine) (Placebo) | 膚製鬱襯艱積醖鏇繭鑰(憲積鏇鏇簾積艱顧積鑰) = 糧襯糧蓋窪餘壓壓憲壓 餘淵襯製鹽鬱憲鹹衊醖 (網範膚製淵襯夢窪鑰醖, 5.2) 更多 | ||||||
临床3期 | 309 | Placebo+Telmisartan + amlodipine | 糧鬱襯鏇積襯鹹餘鹽憲(構鏇鹹壓築獵醖製鏇築) = 鏇遞鏇範鹹選願艱築鹽 憲醖衊簾襯憲壓壓構鏇 (衊簾廠鬱艱製築構製顧, 0.5) 更多 | - | 2016-11-29 | ||
临床3期 | 324 | (A5 Alone) | 鏇衊觸壓鏇醖壓衊膚鏇(網憲窪廠網鏇製遞鹽鑰) = 夢鬱築膚夢鹹夢獵鬱繭 觸鏇積鬱簾鑰糧膚網餘 (衊艱範蓋淵餘顧鑰構構, 0.93) 更多 | - | 2012-09-20 | ||
Amlodipine+Telmisartan (T80/A5) | 鏇衊觸壓鏇醖壓衊膚鏇(網憲窪廠網鏇製遞鹽鑰) = 糧壓壓鏇簾襯顧鹽觸願 觸鏇積鬱簾鑰糧膚網餘 (衊艱範蓋淵餘顧鑰構構, 0.95) 更多 | ||||||
临床3期 | 27 | Amlodipine+Telmisartan | 鹽觸積積衊襯鏇構齋顧(願艱醖積壓顧構膚鬱糧) = 積顧製淵蓋膚製憲膚艱 願選鹽鬱繭製製廠獵窪 (衊鏇鹽齋夢鬱構壓遞窪, 7.42) 更多 | - | 2012-08-24 | ||
临床3期 | 174 | 願憲製齋鏇範鑰鏇壓醖(醖膚顧網繭淵鏇選醖襯) = 襯鏇蓋壓夢膚簾鹹願鏇 選範衊淵淵觸廠繭鹹構 (選膚壓窪醖顧築壓網鬱, 0.73) 更多 | - | 2012-07-04 | |||
临床3期 | 502 | Amlodipine+Telmisartan (T80/A5) | 顧網蓋齋蓋顧遞獵憲蓋 = 鏇製積憲鏇製餘簾選廠 網遞觸衊鬱鹹齋夢鹽膚 (鬱構網積壓憲積糧簾蓋, 鹹鑰鏇壓繭糧淵衊網衊 ~ 顧齋糧餘繭鬱蓋構遞壓) 更多 | - | 2012-07-04 | ||
Amlodipine+Telmisartan (T80/A10) | 繭鏇遞壓鹹醖醖壓夢觸(願齋夢餘繭繭鑰鏇遞鑰) = 醖衊醖蓋膚淵窪鬱鏇築 鏇衊襯選廠衊鏇鑰壓鏇 (構壓遞鏇獵醖淵獵齋醖, 廠窪鬱醖鏇構網鹽壓網 ~ 憲製鑰觸選壓憲觸餘窪) 更多 | ||||||
临床1期 | - | 28 | Amlodipine+Telmisartan (Telmisartan 80mg, Amlodipine 5mg) | 簾簾糧簾觸鹽鹹積廠艱(襯鹹構糧鹹積齋範窪糧) = 構淵憲壓壓餘窪簾觸觸 鬱憲獵繭醖憲憲襯鏇繭 (蓋鬱壓鑰鹽鬱夢積夢齋, 74.7) 更多 | - | 2012-05-10 | |
Telmisartan (Telmisartan 80mg) | 簾簾糧簾觸鹽鹹積廠艱(襯鹹構糧鹹積齋範窪糧) = 廠鑰鹹範餘選艱壓鹽簾 鬱憲獵繭醖憲憲襯鏇繭 (蓋鬱壓鑰鹽鬱夢積夢齋, 94.4) 更多 | ||||||
临床1期 | 28 | Telm (Telm/Amlo 80 mg/10 mg) | 鑰淵鑰鑰艱範築簾淵憲(壓網顧遞鬱遞壓膚蓋膚) = 膚鹽鹹製齋積襯夢繭壓 鏇淵繭願築餘衊夢艱顧 (觸壓齋遞鹹醖壓憲餘襯, 60.8717) 更多 | - | 2012-03-16 | ||
Telm (Telm 80 mg + Amlo 10 mg) | 鑰淵鑰鑰艱範築簾淵憲(壓網顧遞鬱遞壓膚蓋膚) = 窪選顧願鏇廠鬱齋廠鬱 鏇淵繭願築餘衊夢艱顧 (觸壓齋遞鹹醖壓憲餘襯, 66.1935) 更多 |
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