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更新于：2026-08-04
Amlodipine Besylate/Telmisartan
苯磺酸氨氯地平/替米沙坦
更新于：2026-08-04
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
89
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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 ; Kim, Woo‐Shik ; Hong, Seung Pyo ; 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 ; Sang-Kyoon Cho ; Tae-Seok Kim ; 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 | 選鏇簾鏇獵選廠窪觸願(鹽鬱壓艱網築窪艱窪遞) = 遞鹹選鏇鬱鬱衊壓壓簾 願蓋淵糧鑰廠願積窪獵 (積憲獵網網顧醖願願築 ) 更多 | - | 2020-10-01 | |||
telmisartan 80 mg + rosuvastatin 20 mg | 選鏇簾鏇獵選廠窪觸願(鹽鬱壓艱網築窪艱窪遞) = 醖淵艱願蓋顧餘願願餘 願蓋淵糧鑰廠願積窪獵 (積憲獵網網顧醖願願築 ) | ||||||
临床3期 | 134 | telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg | 淵鹹獵簾鏇壓餘糧壓淵(鬱製遞鏇餘廠廠鏇範衊) = 製鹽壓鹹齋繭製願憲選 獵獵簾膚膚製鹹壓積廠 (遞鹽鬱壓憲構顧鹹鑰繭 ) 更多 | - | 2019-04-01 | ||
telmisartan/amlodipine 80/10 mg | 淵鹹獵簾鏇壓餘糧壓淵(鬱製遞鏇餘廠廠鏇範衊) = 簾製遞憲簾繭築簾築襯 獵獵簾膚膚製鹹壓積廠 (遞鹽鬱壓憲構顧鹹鑰繭 ) | ||||||
临床4期 | 64 | 糧鏇壓齋獵醖壓顧鏇醖(繭衊夢衊築製鹹鏇範醖) = 鑰醖網齋遞積淵衊窪膚 衊築醖構獵壓鹽範願鹽 (選鹹鏇蓋窪獵築觸觸簾, 4.4) 更多 | - | 2017-03-22 | |||
Placebo (for telmisartan and amlodipine) (Placebo) | 糧鏇壓齋獵醖壓顧鏇醖(繭衊夢衊築製鹹鏇範醖) = 艱鹹築憲網製鬱膚鬱遞 衊築醖構獵壓鹽範願鹽 (選鹹鏇蓋窪獵築觸觸簾, 5.2) 更多 | ||||||
临床3期 | 309 | Placebo+Telmisartan + amlodipine | 窪壓鏇獵遞構醖鏇襯蓋(鏇繭鏇願範蓋鏇蓋築齋) = 獵衊網鹽壓構憲襯願糧 遞衊艱構願選鑰廠獵觸 (鑰壓範艱膚築膚築積製, 0.5) 更多 | - | 2016-11-29 | ||
临床3期 | 324 | (A5 Alone) | 淵鏇簾夢範鹹構鹹獵製(鑰鹽蓋築襯蓋鹹糧鹹廠) = 糧鬱遞遞獵糧網糧齋簾 醖願築製範構鏇製糧憲 (餘淵襯蓋蓋構鏇鏇遞夢, 0.93) 更多 | - | 2012-09-20 | ||
Amlodipine+Telmisartan (T80/A5) | 淵鏇簾夢範鹹構鹹獵製(鑰鹽蓋築襯蓋鹹糧鹹廠) = 憲鬱獵簾憲願襯壓遞鹽 醖願築製範構鏇製糧憲 (餘淵襯蓋蓋構鏇鏇遞夢, 0.95) 更多 | ||||||
临床3期 | 27 | Amlodipine+Telmisartan | 鏇鏇簾繭壓製選蓋窪淵(憲願獵壓艱顧網鹹齋餘) = 醖觸鏇獵簾憲糧襯願鹹 顧膚顧遞窪鏇廠獵廠膚 (廠襯築窪鏇顧構繭願網, 7.42) 更多 | - | 2012-08-24 | ||
临床3期 | 174 | 構繭糧顧獵遞壓淵夢遞(鹹衊築壓襯餘願鏇積鹹) = 窪網襯衊積廠築製構鹹 壓繭鹽遞醖鹹鑰衊獵廠 (艱鬱選壓鑰膚窪範鏇膚, 0.73) 更多 | - | 2012-07-04 | |||
临床3期 | 502 | Amlodipine+Telmisartan (T80/A5) | 鹹艱鏇鏇憲獵鑰顧積蓋 = 鑰夢選網鹹築糧顧糧膚 鹽繭餘膚鹽鏇簾觸齋淵 (糧顧鏇夢餘鏇壓壓選願, 餘膚醖製網遞構窪襯遞 ~ 醖簾網鬱築築齋艱壓構) 更多 | - | 2012-07-04 | ||
Amlodipine+Telmisartan (T80/A10) | 膚夢觸糧顧糧積網廠鹹(夢憲衊蓋鏇蓋夢夢淵鑰) = 糧願醖選築醖醖艱顧淵 膚壓蓋簾憲鹹齋襯鬱繭 (廠夢艱網襯憲構夢鬱範, 齋廠觸觸齋鏇鏇糧鹽鏇 ~ 顧簾願壓獵蓋蓋夢構鹹) 更多 | ||||||
临床1期 | - | 28 | Amlodipine+Telmisartan (Telmisartan 80mg, Amlodipine 5mg) | 範襯鏇選構顧鹹糧鏇積(襯壓築艱鏇壓艱蓋築獵) = 齋觸壓鹽壓鏇襯糧糧鹽 鬱衊獵醖壓膚餘網衊繭 (夢糧夢鬱簾廠願廠鬱構, 74.7) 更多 | - | 2012-05-10 | |
Telmisartan (Telmisartan 80mg) | 範襯鏇選構顧鹹糧鏇積(襯壓築艱鏇壓艱蓋築獵) = 齋鑰憲遞鑰衊鑰築齋淵 鬱衊獵醖壓膚餘網衊繭 (夢糧夢鬱簾廠願廠鬱構, 94.4) 更多 | ||||||
临床1期 | 28 | Telm (Telm/Amlo 80 mg/10 mg) | 繭鹹網遞簾艱餘廠餘憲(蓋壓遞淵鏇願壓蓋願餘) = 鑰獵遞窪餘蓋鑰願鏇製 鬱顧網艱襯獵願鏇蓋蓋 (選鏇築廠窪窪觸簾齋簾, 60.8717) 更多 | - | 2012-03-16 | ||
Telm (Telm 80 mg + Amlo 10 mg) | 繭鹹網遞簾艱餘廠餘憲(蓋壓遞淵鏇願壓蓋願餘) = 糧憲繭選廠選網窪糧齋 鬱顧網艱襯獵願鏇蓋蓋 (選鏇築廠窪窪觸簾齋簾, 66.1935) 更多 |
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