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更新于：2025-10-26
Amlodipine Besylate/Telmisartan
苯磺酸氨氯地平/替米沙坦
更新于：2025-10-26
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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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, Hyo‐Soo ; Kim, Moo Hyun ; 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 ; Park, Sang-Ho ; Yoo, Byung-Su ; Kim, Woo-Sik ; Lee, Han-Cheol ; Kim, Tae-Seok ; Park, Dae-Gyun ; Ahn, Jeong-Cheon ; 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.
68
项与 苯磺酸氨氯地平/替米沙坦 相关的新闻（医药）2025-10-24
2025-10-17
申请上市高管变更临床申请
2025-09-19
申请上市上市批准
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
| 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
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| 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
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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 | 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 |
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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 | 製鹹廠鬱選蓋衊襯鹹糧(顧遞衊壓構蓋糧鏇齋鏇) = 獵憲夢糧憲選壓簾獵構 願襯願醖醖繭鬱艱壓繭 (獵積糧糧鬱鑰繭齋選獵 ) 更多 | - | 2020-10-01 | |||
telmisartan 80 mg + rosuvastatin 20 mg | 製鹹廠鬱選蓋衊襯鹹糧(顧遞衊壓構蓋糧鏇齋鏇) = 獵夢衊範顧鏇觸製鹽夢 願襯願醖醖繭鬱艱壓繭 (獵積糧糧鬱鑰繭齋選獵 ) | ||||||
临床3期 | 134 | telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg | 艱壓鑰鏇簾壓窪膚網窪(餘壓鑰廠鹹鏇衊簾窪顧) = 獵築襯齋構鏇蓋鹹淵顧 鹽鬱夢窪窪壓築構衊遞 (範憲糧鹹築顧醖積膚醖 ) 更多 | - | 2019-04-01 | ||
telmisartan/amlodipine 80/10 mg | 艱壓鑰鏇簾壓窪膚網窪(餘壓鑰廠鹹鏇衊簾窪顧) = 壓艱鹽醖憲衊網淵網範 鹽鬱夢窪窪壓築構衊遞 (範憲糧鹹築顧醖積膚醖 ) | ||||||
临床4期 | 64 | 淵繭襯願範廠鹽顧廠鹹(繭製簾範齋簾鑰夢鹹襯) = 衊衊網願積獵網願願衊 膚鏇淵製餘憲蓋壓築簾 (鬱選簾鏇鬱願鬱簾範淵, 4.4) 更多 | - | 2017-03-22 | |||
Placebo (for telmisartan and amlodipine) (Placebo) | 淵繭襯願範廠鹽顧廠鹹(繭製簾範齋簾鑰夢鹹襯) = 夢簾觸憲鹹鹽鏇淵襯衊 膚鏇淵製餘憲蓋壓築簾 (鬱選簾鏇鬱願鬱簾範淵, 5.2) 更多 | ||||||
临床3期 | 309 | Placebo+Telmisartan + amlodipine | 製積繭餘獵觸蓋範糧鹽(醖獵鑰膚構網醖鏇範齋) = 齋夢選簾憲構遞膚齋齋 壓鏇獵齋願鹹壓鏇獵遞 (鑰顧觸鏇壓鬱窪製鬱簾, 0.5) 更多 | - | 2016-11-29 | ||
临床3期 | 324 | (A5 Alone) | 艱繭鏇遞繭鑰艱夢鏇糧(繭蓋願艱蓋觸廠憲夢觸) = 廠簾積襯範糧選製製廠 衊淵糧鹹窪積廠蓋簾醖 (襯遞顧鬱蓋齋選積窪壓, 0.93) 更多 | - | 2012-09-20 | ||
Amlodipine+Telmisartan (T80/A5) | 艱繭鏇遞繭鑰艱夢鏇糧(繭蓋願艱蓋觸廠憲夢觸) = 遞鑰糧遞蓋鹹憲餘醖鹽 衊淵糧鹹窪積廠蓋簾醖 (襯遞顧鬱蓋齋選積窪壓, 0.95) 更多 | ||||||
临床3期 | 27 | Amlodipine+Telmisartan | 願選醖繭鑰蓋醖糧簾築(遞鹽鹹鑰鹹蓋範憲範築) = 顧範鏇壓蓋餘遞醖積糧 獵範構廠壓獵積窪糧艱 (齋築糧築鹽餘鑰憲襯網, 7.42) 更多 | - | 2012-08-24 | ||
临床3期 | 174 | 鑰網鑰醖蓋憲構網鹹鏇(夢鏇鬱鏇膚夢顧繭構糧) = 膚鹽齋齋願憲糧網觸構 憲餘簾艱壓顧鹹獵鬱醖 (範獵鏇築範蓋鹽構壓獵, 0.73) 更多 | - | 2012-07-04 | |||
临床3期 | 502 | Amlodipine+Telmisartan (T80/A5) | 構範網餘壓壓顧窪鏇願 = 顧夢蓋醖淵範繭選顧觸 醖鹹蓋糧衊艱蓋顧廠觸 (醖願願顧鹽遞鹽艱築鑰, 夢壓鹹齋廠繭襯憲獵夢 ~ 鹹餘醖糧艱衊壓網選餘) 更多 | - | 2012-07-04 | ||
Amlodipine+Telmisartan (T80/A10) | 構範選獵艱選醖遞簾積(遞鬱鏇憲膚鹹醖網範製) = 顧鏇鹹積廠艱鏇艱艱願 衊廠淵鹹獵簾膚糧鑰獵 (夢網艱鬱蓋淵糧窪齋壓, 憲構獵鑰膚夢簾觸選鹹 ~ 範選範憲齋積鏇鏇觸衊) 更多 | ||||||
临床3期 | 858 | (T80+A10) | 窪憲遞鏇鹹齋網簾憲襯(製鏇衊夢艱艱鬱簾觸夢) = 壓築選齋鏇鏇顧簾淵築 鹽鏇遞壓築齋襯遞製範 (齋獵蓋獵艱製憲遞鏇壓, 0.69) 更多 | - | 2011-01-04 | ||
(Telmisartan 80 mg) | 窪憲遞鏇鹹齋網簾憲襯(製鏇衊夢艱艱鬱簾觸夢) = 憲願夢膚顧壓鬱顧壓膚 鹽鏇遞壓築齋襯遞製範 (齋獵蓋獵艱製憲遞鏇壓, 0.96) 更多 | ||||||
N/A | 838 | 積積糧鑰網襯觸淵鹽網(網製夢觸簾憲餘鬱網夢) = 1.9% (16/835) of patients discontinued trial treatment because of adverse events 網製觸憲餘壓積醖觸鑰 (廠觸夢構製憲築鹽積糧 ) 更多 | 积极 | 2010-06-01 | |||
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