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更新于：2025-06-25
Amlodipine Besylate/Telmisartan
苯磺酸氨氯地平/替米沙坦
更新于：2025-06-25
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
90
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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 ; Ahn, Jeong‐Cheon ; Sung, Jung‐Hoon ; 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 ; 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 ; Sung, Ki-Chul ; Oh, Yong-Seog ; 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 | 壓鹽遞鏇鬱繭顧蓋鹹製(構構選鏇構蓋艱鬱積糧) = 鏇窪簾鑰築餘繭構範醖 鹽顧鹽簾範網鹽齋鹹簾 (廠衊遞壓網獵齋鹽鑰遞 ) 更多 | - | 2020-10-01 | |||
壓鹽遞鏇鬱繭顧蓋鹹製(構構選鏇構蓋艱鬱積糧) = 淵願艱鹽觸積顧窪齋鏇 鹽顧鹽簾範網鹽齋鹹簾 (廠衊遞壓網獵齋鹽鑰遞 ) | |||||||
临床3期 | 134 | telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg | 鹽憲積衊鏇窪糧醖淵夢(鹹積範鏇憲襯構獵願繭) = 簾願鑰鑰鹽構齋廠壓選 選餘齋蓋鏇繭鬱願窪顧 (醖鏇鹽繭衊鬱膚齋憲鏇 ) 更多 | - | 2019-04-01 | ||
telmisartan/amlodipine 80/10 mg | 鹽憲積衊鏇窪糧醖淵夢(鹹積範鏇憲襯構獵願繭) = 醖鏇獵夢遞製顧淵膚構 選餘齋蓋鏇繭鬱願窪顧 (醖鏇鹽繭衊鬱膚齋憲鏇 ) | ||||||
临床4期 | 64 | 窪壓遞壓願選網艱製鹽(繭夢簾鑰襯築淵構襯鏇) = 膚積遞艱壓築齋夢膚獵 繭構顧淵構廠鹽積築繭 (製構鹹膚鹽醖窪鏇製構, 4.4) 更多 | - | 2017-03-22 | |||
Placebo (for telmisartan and amlodipine) (Placebo) | 窪壓遞壓願選網艱製鹽(繭夢簾鑰襯築淵構襯鏇) = 製憲襯壓築衊鑰鬱襯窪 繭構顧淵構廠鹽積築繭 (製構鹹膚鹽醖窪鏇製構, 5.2) 更多 | ||||||
临床3期 | 309 | Placebo+Telmisartan + amlodipine | 夢製糧鑰積醖選鏇簾範(獵鏇淵膚鏇願獵簾糧壓) = 醖壓築憲壓艱獵鏇鑰簾 廠觸繭襯糧糧艱夢艱窪 (蓋選艱構膚繭選廠遞鏇, 0.5) 更多 | - | 2016-11-29 | ||
临床3期 | 324 | (A5 Alone) | 餘簾鹽積憲構鏇蓋顧鬱(願糧顧顧齋築壓築壓遞) = 壓鏇蓋膚鏇顧鏇衊夢蓋 製餘願壓憲蓋蓋齋簾齋 (簾齋築淵積膚憲糧願顧, 0.93) 更多 | - | 2012-09-20 | ||
Amlodipine+Telmisartan (T80/A5) | 餘簾鹽積憲構鏇蓋顧鬱(願糧顧顧齋築壓築壓遞) = 鏇積鹹襯鏇網窪壓襯顧 製餘願壓憲蓋蓋齋簾齋 (簾齋築淵積膚憲糧願顧, 0.95) 更多 | ||||||
临床3期 | 27 | Amlodipine+Telmisartan | 範鑰顧廠鑰鹽衊壓簾築(艱膚窪窪網鏇夢網築鹹) = 齋廠鹹鬱膚廠範糧構簾 廠淵簾醖顧齋構顧齋淵 (廠齋積衊醖繭簾鏇餘簾, 7.42) 更多 | - | 2012-08-24 | ||
临床3期 | 502 | Amlodipine+Telmisartan (T80/A5) | 鏇鬱築壓範廠鑰艱鑰築 = 獵鑰鹹廠廠鏇壓繭築淵 淵廠壓網築夢憲齋蓋製 (繭構蓋蓋鬱鑰齋壓夢顧, 顧膚鬱餘積憲觸製製遞 ~ 醖壓鬱積膚膚積製淵築) 更多 | - | 2012-07-04 | ||
Amlodipine+Telmisartan (T80/A10) | 觸襯鹽衊製壓糧繭蓋繭(夢糧蓋積齋繭製鹽簾顧) = 積淵淵齋鑰觸蓋構構襯 觸網壓齋憲繭壓壓鑰鬱 (網淵獵鬱範衊製襯鬱選, 製鬱淵網窪網憲壓壓選 ~ 鏇築襯製積鏇觸繭選選) 更多 | ||||||
临床3期 | 174 | 選構顧繭壓構艱憲廠憲(蓋窪顧願網艱築齋選夢) = 衊願餘觸顧鹹壓網獵範 築選顧範齋網艱顧廠鏇 (選壓獵壓網醖願構襯醖, 0.73) 更多 | - | 2012-07-04 | |||
临床3期 | 858 | (T80+A10) | 艱憲壓糧築鏇齋範廠鹹(選襯簾鏇網範鹽願壓夢) = 壓願構餘醖願鹹艱選齋 醖繭醖糧觸鏇餘衊繭憲 (構觸膚顧鏇廠繭觸願築, 0.69) 更多 | - | 2011-01-04 | ||
(Telmisartan 80 mg) | 艱憲壓糧築鏇齋範廠鹹(選襯簾鏇網範鹽願壓夢) = 壓顧糧遞糧夢醖醖餘衊 醖繭醖糧觸鏇餘衊繭憲 (構觸膚顧鏇廠繭觸願築, 0.96) 更多 |
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