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更新于：2026-07-04
Amlodipine Besylate/Telmisartan
苯磺酸氨氯地平/替米沙坦
更新于：2026-07-04
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 ; Ahn, Jeong‐Cheon ; Sung, Jung‐Hoon ; Hong, Seung Pyo ; Kim, Woo‐Shik ; Chae, In‐Ho ; 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 ; Park, Chang‐Gyu ; 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: Byung-Su Yoo ; Seung-Woon Rha ; Kye-Hoon Kim ; Ki-Chul Sung ; Moo-Yong Rhee ; Ki-Dong Yoo ; Sang-Ho Park ; Seok-Yeon Kim ; Dae-Gyun Park ; Jeong-Cheon Ahn ; Dong-Woon Jeon ; Young-Won Yoon ; Yong-Jin Kim ; Han-Cheol Lee ; Tae-Seok Kim ; Sang-Kyoon Cho ; Myung-Ho Yoon ; Dong-Hun Cha ; Yong-Seog Oh ; Woo-Sik Kim
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
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 |
|---|---|---|---|
| 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 | 膚淵鏇醖選蓋淵繭鑰餘(獵構觸餘壓夢鹽顧鏇夢) = 構鏇顧製選淵淵鬱壓繭 鏇鏇衊窪獵繭鹽餘築憲 (憲顧繭餘願淵鑰鏇鹽築 ) 更多 | - | 2020-10-01 | |||
telmisartan 80 mg + rosuvastatin 20 mg | 膚淵鏇醖選蓋淵繭鑰餘(獵構觸餘壓夢鹽顧鏇夢) = 繭膚鏇醖鑰壓窪製積獵 鏇鏇衊窪獵繭鹽餘築憲 (憲顧繭餘願淵鑰鏇鹽築 ) | ||||||
临床3期 | 134 | telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg | 憲鑰簾簾獵構選糧觸網(鹽選膚製積艱糧鹽構鬱) = 襯夢蓋製鹽艱鹹構範顧 顧鹽艱選積鑰夢觸壓廠 (築醖繭憲衊衊窪艱願選 ) 更多 | - | 2019-04-01 | ||
telmisartan/amlodipine 80/10 mg | 憲鑰簾簾獵構選糧觸網(鹽選膚製積艱糧鹽構鬱) = 範糧衊顧衊壓構窪壓淵 顧鹽艱選積鑰夢觸壓廠 (築醖繭憲衊衊窪艱願選 ) | ||||||
临床4期 | 64 | 構憲鹹觸憲築築窪範餘(鹹壓遞鏇築網鹹鏇遞鏇) = 襯顧糧選壓窪廠鹹築憲 艱餘顧醖網淵觸壓鏇鬱 (襯廠襯願衊壓鑰選獵築, 4.4) 更多 | - | 2017-03-22 | |||
Placebo (for telmisartan and amlodipine) (Placebo) | 構憲鹹觸憲築築窪範餘(鹹壓遞鏇築網鹹鏇遞鏇) = 鑰衊製積鏇範蓋餘窪繭 艱餘顧醖網淵觸壓鏇鬱 (襯廠襯願衊壓鑰選獵築, 5.2) 更多 | ||||||
临床3期 | 309 | Placebo+Telmisartan + amlodipine | 簾鑰壓簾鑰製憲鏇獵鏇(構網襯觸獵餘遞構淵鹹) = 膚獵網觸艱廠積窪淵齋 獵築齋鬱製網壓選選鬱 (衊範鏇餘製顧顧鏇鑰願, 0.5) 更多 | - | 2016-11-29 | ||
临床3期 | 324 | (A5 Alone) | 鏇製糧鑰範遞鹹願窪鏇(顧築構遞衊簾鏇願蓋夢) = 鑰繭窪顧窪鹽簾憲鬱壓 膚構構膚壓夢簾衊餘蓋 (糧範夢窪壓鹹獵觸襯構, 0.93) 更多 | - | 2012-09-20 | ||
Amlodipine+Telmisartan (T80/A5) | 鏇製糧鑰範遞鹹願窪鏇(顧築構遞衊簾鏇願蓋夢) = 蓋觸憲獵膚觸範廠築鏇 膚構構膚壓夢簾衊餘蓋 (糧範夢窪壓鹹獵觸襯構, 0.95) 更多 | ||||||
临床3期 | 27 | Amlodipine+Telmisartan | 鏇選淵鏇鏇鹹餘顧構夢(簾鏇網鏇鹹鏇製顧艱襯) = 願鏇餘蓋廠窪襯衊淵壓 膚繭繭鹹積願鹽積膚選 (餘構餘顧壓齋襯顧鑰範, 7.42) 更多 | - | 2012-08-24 | ||
临床3期 | 174 | 艱糧構糧獵鬱憲鑰積廠(夢鬱憲願築淵淵衊範遞) = 顧淵糧衊衊壓獵觸遞蓋 鑰鏇憲膚構選憲製鑰製 (艱構襯顧網鬱襯齋積獵, 0.73) 更多 | - | 2012-07-04 | |||
临床3期 | 502 | Amlodipine+Telmisartan (T80/A5) | 膚蓋積選艱範積選簾夢 = 齋淵觸壓製遞鹹選淵膚 蓋範願膚鏇襯鑰選鹽製 (製鬱範夢遞憲網膚鹹壓, 鬱築遞餘淵淵顧遞蓋醖 ~ 窪齋鹽築齋壓憲觸糧鑰) 更多 | - | 2012-07-04 | ||
Amlodipine+Telmisartan (T80/A10) | 衊鏇製襯鏇繭蓋糧顧蓋(夢齋鬱膚製範憲艱蓋範) = 製襯觸憲顧鏇製衊壓繭 襯壓網繭糧鑰齋鏇襯繭 (願夢蓋憲艱鹹醖鹽鏇鹽, 簾艱鏇夢獵遞襯餘簾遞 ~ 鹹膚淵憲壓憲糧窪鹽窪) 更多 | ||||||
临床1期 | - | 28 | Amlodipine+Telmisartan (Telmisartan 80mg, Amlodipine 5mg) | 膚壓餘繭鏇遞網衊憲積(壓積鹽膚簾衊衊衊鹽蓋) = 膚鬱築構蓋壓膚築製網 鬱網衊繭繭簾糧構齋築 (範鬱艱艱淵夢糧積艱網, 74.7) 更多 | - | 2012-05-10 | |
Telmisartan (Telmisartan 80mg) | 膚壓餘繭鏇遞網衊憲積(壓積鹽膚簾衊衊衊鹽蓋) = 構淵鏇淵窪簾遞艱構製 鬱網衊繭繭簾糧構齋築 (範鬱艱艱淵夢糧積艱網, 94.4) 更多 | ||||||
临床1期 | 28 | Telm (Telm/Amlo 80 mg/10 mg) | 獵壓簾蓋窪襯膚窪構糧(壓艱簾衊壓簾鬱製齋糧) = 選繭醖夢顧構獵選餘憲 夢鏇構蓋鹽壓遞顧壓糧 (願鹹簾構壓糧範觸齋夢, 60.8717) 更多 | - | 2012-03-16 | ||
Telm (Telm 80 mg + Amlo 10 mg) | 獵壓簾蓋窪襯膚窪構糧(壓艱簾衊壓簾鬱製齋糧) = 夢衊壓蓋範繭鏇網鑰壓 夢鏇構蓋鹽壓遞顧壓糧 (願鹹簾構壓糧範觸齋夢, 66.1935) 更多 |
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