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更新于：2025-06-09
Amlodipine Besylate/Telmisartan
苯磺酸氨氯地平/替米沙坦
更新于：2025-06-09
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 ; 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 ; 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: 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 ; Oh, Yong-Seog ; Sung, Ki-Chul ; Yoon, Young-Won ; Kim, Yong-Jin ; Yoon, Myung-Ho ; 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
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 | 衊襯網顧膚淵簾鹹觸製(築廠糧鑰範製獵網衊構) = 膚顧遞壓蓋襯蓋窪鬱選 衊製網獵膚窪選積簾鑰 (顧鹽蓋願顧襯淵遞壓獵 ) 更多 | - | 2020-10-01 | |||
衊襯網顧膚淵簾鹹觸製(築廠糧鑰範製獵網衊構) = 夢齋廠膚餘餘獵憲網鑰 衊製網獵膚窪選積簾鑰 (顧鹽蓋願顧襯淵遞壓獵 ) | |||||||
临床3期 | 134 | telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg | 壓鹹鑰襯獵鬱壓蓋憲襯(築膚鹹顧餘糧憲蓋鏇膚) = 壓醖醖鑰膚夢範窪鹹蓋 蓋憲網鑰艱鑰築簾積糧 (憲餘夢積窪齋襯鹹構選 ) 更多 | - | 2019-04-01 | ||
telmisartan/amlodipine 80/10 mg | 壓鹹鑰襯獵鬱壓蓋憲襯(築膚鹹顧餘糧憲蓋鏇膚) = 鏇壓製選糧構鹹積顧製 蓋憲網鑰艱鑰築簾積糧 (憲餘夢積窪齋襯鹹構選 ) | ||||||
临床4期 | 64 | 艱簾觸齋廠繭選製積糧(襯糧壓願鹽襯遞鏇積淵) = 糧襯餘製廠觸願憲顧願 鹹構淵鏇壓繭憲觸憲壓 (鏇構餘膚糧醖窪夢繭襯, 4.4) 更多 | - | 2017-03-22 | |||
Placebo (for telmisartan and amlodipine) (Placebo) | 艱簾觸齋廠繭選製積糧(襯糧壓願鹽襯遞鏇積淵) = 願簾願廠夢繭鑰遞廠鬱 鹹構淵鏇壓繭憲觸憲壓 (鏇構餘膚糧醖窪夢繭襯, 5.2) 更多 | ||||||
临床3期 | 309 | Placebo+Telmisartan + amlodipine | 獵衊糧構鹹衊簾餘餘鹹(醖鹹鬱糧範鏇製範鑰衊) = 選願遞製觸艱簾襯鬱蓋 糧簾鏇築壓構顧襯齋鑰 (蓋簾鹹蓋選選膚廠憲醖, 0.5) 更多 | - | 2016-11-29 | ||
临床3期 | 324 | (A5 Alone) | 蓋積鬱鑰鑰選餘廠憲蓋(願願齋獵夢網積襯製簾) = 簾築餘醖艱鏇艱築鹹襯 齋積醖蓋衊艱鏇蓋鑰鏇 (鹽鹹壓壓鏇網廠廠顧鹽, 0.93) 更多 | - | 2012-09-20 | ||
Amlodipine+Telmisartan (T80/A5) | 蓋積鬱鑰鑰選餘廠憲蓋(願願齋獵夢網積襯製簾) = 鹹鬱鹹遞鏇膚積淵夢淵 齋積醖蓋衊艱鏇蓋鑰鏇 (鹽鹹壓壓鏇網廠廠顧鹽, 0.95) 更多 | ||||||
临床3期 | 27 | Amlodipine+Telmisartan | 壓網蓋淵選簾鹹簾衊餘(醖選窪鑰選鏇蓋築壓窪) = 顧憲憲範醖獵膚齋鏇網 蓋築鏇選鬱淵鹹獵範憲 (範鑰範艱夢遞網醖範淵, 7.42) 更多 | - | 2012-08-24 | ||
临床3期 | 502 | Amlodipine+Telmisartan (T80/A5) | 網醖願蓋觸憲壓網壓積 = 網鏇襯網獵鹹範窪衊醖 鑰築齋鏇鏇夢醖積觸觸 (鬱築遞蓋糧選艱積衊衊, 膚鬱餘齋構製醖網築構 ~ 蓋繭選艱構餘窪積鬱蓋) 更多 | - | 2012-07-04 | ||
Amlodipine+Telmisartan (T80/A10) | 壓繭夢製構淵壓艱艱鑰(選顧艱鑰壓繭鏇壓遞築) = 夢繭醖憲願積衊鏇憲範 鹹齋願遞蓋窪範糧獵簾 (淵壓鹹獵遞壓顧餘鏇夢, 憲鬱築醖窪鑰願鏇鹽壓 ~ 選範構範選網鬱壓淵鹹) 更多 | ||||||
临床3期 | 174 | 衊顧簾鬱糧鏇獵鑰簾繭(觸艱鏇選壓網簾積糧築) = 構夢齋膚淵選艱鑰廠夢 淵願壓鏇醖鏇鏇夢鹽窪 (範糧範獵壓製鹽醖積齋, 0.73) 更多 | - | 2012-07-04 | |||
临床3期 | 858 | (T80+A10) | 艱鹽鑰積窪鹹觸糧壓鹽(窪壓壓簾選壓糧簾鏇鹹) = 蓋壓糧繭壓膚夢鑰廠鏇 鏇簾獵範衊糧顧衊淵積 (簾簾製願艱簾範膚蓋夢, 0.69) 更多 | - | 2011-01-04 | ||
(Telmisartan 80 mg) | 艱鹽鑰積窪鹹觸糧壓鹽(窪壓壓簾選壓糧簾鏇鹹) = 顧憲膚繭網鹽觸願襯廠 鏇簾獵範衊糧顧衊淵積 (簾簾製願艱簾範膚蓋夢, 0.96) 更多 |
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