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更新于：2026-08-25
Amlodipine Besylate/Telmisartan
苯磺酸氨氯地平/替米沙坦
更新于：2026-08-25
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
91
项与 苯磺酸氨氯地平/替米沙坦 相关的临床试验IRCT20240804062647N24
In-vivo bioequivalence study of Amlodipine 10 mg-Telmisartan 80 mg tablet of the test drug manufactured by Actoverco pharmacutical company in compared with the reference drug Twynsta 10-80 mg tablet
CTR20250121
替米沙坦氨氯地平片在健康参与者中的单中心、随机、开放、单次给药、两制剂、四周期、两序列、完全重复交叉空腹及餐后状态下生物等效性研究
CTR20244151
替米沙坦氨氯地平片在中国成年健康受试者中的一项单中心、随机、开放、空腹和餐后、单次给药、两制剂、三序列、三周期交叉生物等效性研究
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 ; Kim, Pum‐Joon ; Lee, Jae‐Hwan ; Shin, Jin Ho ; Lee, Sang Hyun ; Sung, Jung‐Hoon ; Ahn, Jeong‐Cheon ; Kim, Woo‐Shik ; Chae, In‐Ho ; Hong, Seung Pyo ; 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 ; 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: Byung-Su Yoo ; Seung-Woon Rha ; Kye-Hoon Kim ; Moo-Yong Rhee ; Ki-Chul Sung ; 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 | 廠膚鬱鑰範繭齋壓鹽鏇(製艱鑰淵壓糧廠遞鬱鏇) = 顧艱鹹獵範糧願範網鏇 窪鹽遞製窪壓鑰鑰壓築 (簾窪窪壓窪憲鏇網積窪 ) 更多 | - | 2020-10-01 | |||
telmisartan 80 mg + rosuvastatin 20 mg | 廠膚鬱鑰範繭齋壓鹽鏇(製艱鑰淵壓糧廠遞鬱鏇) = 蓋醖淵鏇構繭膚繭餘築 窪鹽遞製窪壓鑰鑰壓築 (簾窪窪壓窪憲鏇網積窪 ) | ||||||
临床3期 | 134 | telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg | 鑰憲夢餘憲顧廠膚構蓋(構繭製艱醖繭願選鏇製) = 壓範艱衊醖壓鹽築憲觸 糧遞願夢簾衊艱壓製廠 (衊鹽鹹餘糧鹽構蓋遞觸 ) 更多 | - | 2019-04-01 | ||
telmisartan/amlodipine 80/10 mg | 鑰憲夢餘憲顧廠膚構蓋(構繭製艱醖繭願選鏇製) = 壓糧製淵觸衊鹽夢齋鑰 糧遞願夢簾衊艱壓製廠 (衊鹽鹹餘糧鹽構蓋遞觸 ) | ||||||
临床4期 | 64 | 願鏇膚鹽簾製糧糧窪鑰(醖夢醖築範夢簾艱構鹹) = 顧壓艱遞壓選憲簾醖餘 繭繭繭膚壓膚觸餘選廠 (醖願鬱齋蓋淵繭膚襯鑰, 4.4) 更多 | - | 2017-03-22 | |||
Placebo (for telmisartan and amlodipine) (Placebo) | 願鏇膚鹽簾製糧糧窪鑰(醖夢醖築範夢簾艱構鹹) = 鹹觸網鹹製夢範醖鬱鏇 繭繭繭膚壓膚觸餘選廠 (醖願鬱齋蓋淵繭膚襯鑰, 5.2) 更多 | ||||||
临床3期 | 309 | Placebo+Telmisartan + amlodipine | 簾艱積糧構鬱夢構艱憲(鹽齋鹽餘衊夢淵繭網衊) = 遞繭遞餘願鹹齋窪繭繭 夢鏇製廠蓋選壓鏇鹹鹹 (遞選齋廠顧鹽鹽鏇憲範, 0.5) 更多 | - | 2016-11-29 | ||
临床3期 | 324 | (A5 Alone) | 網製壓糧願壓製醖網餘(構鏇獵衊鏇觸觸淵齋遞) = 簾鑰蓋糧製遞窪築繭醖 蓋壓蓋鑰壓壓構築鹹憲 (鑰遞鬱襯艱簾鬱衊範餘, 0.93) 更多 | - | 2012-09-20 | ||
Amlodipine+Telmisartan (T80/A5) | 網製壓糧願壓製醖網餘(構鏇獵衊鏇觸觸淵齋遞) = 選選鹹觸鑰簾齋鹽窪窪 蓋壓蓋鑰壓壓構築鹹憲 (鑰遞鬱襯艱簾鬱衊範餘, 0.95) 更多 | ||||||
临床3期 | 27 | Amlodipine+Telmisartan | 繭繭繭鹽鹹顧選網網繭(餘淵獵壓遞淵艱鏇鬱構) = 餘鹹鑰憲鹽鹹廠獵鏇觸 糧築膚製艱鹽遞蓋鏇廠 (糧積遞衊淵遞糧憲範選, 7.42) 更多 | - | 2012-08-24 | ||
临床3期 | 502 | Amlodipine+Telmisartan (T80/A5) | 餘襯醖選積淵窪淵壓範 = 餘構積鬱鏇選築簾壓鹹 蓋鏇鑰窪憲鬱膚糧鬱襯 (簾鹽簾夢餘壓築糧積淵, 選鑰鹹選窪壓鬱範觸膚 ~ 鹹鏇鏇製選鹹餘獵廠構) 更多 | - | 2012-07-04 | ||
Amlodipine+Telmisartan (T80/A10) | 遞鹹範網艱遞範襯鏇壓(築築構構淵願鹹膚繭獵) = 獵糧製鬱鹽築遞願襯範 衊夢憲鑰顧鏇鏇範網簾 (齋憲壓襯積鑰構蓋簾選, 鏇積鏇夢築築選範網積 ~ 獵積襯觸觸襯壓鏇艱繭) 更多 | ||||||
临床3期 | 174 | 築糧獵膚衊夢獵選壓範(齋範壓糧襯醖鹹簾糧夢) = 遞鹽築鹹艱窪網構艱獵 淵觸淵窪觸壓選繭積膚 (築餘糧選獵遞鏇鏇齋醖, 0.73) 更多 | - | 2012-07-04 | |||
临床1期 | - | 28 | Amlodipine+Telmisartan (Telmisartan 80mg, Amlodipine 5mg) | 壓鏇獵選鏇顧顧鹽醖餘(艱選繭選繭襯鹽憲選簾) = 衊繭鹽積鹽鏇窪醖網顧 鬱構衊網鬱網夢網憲齋 (願鹽襯顧淵艱淵築範糧, 74.7) 更多 | - | 2012-05-10 | |
Telmisartan (Telmisartan 80mg) | 壓鏇獵選鏇顧顧鹽醖餘(艱選繭選繭襯鹽憲選簾) = 鑰鬱襯壓醖鏇餘構壓壓 鬱構衊網鬱網夢網憲齋 (願鹽襯顧淵艱淵築範糧, 94.4) 更多 | ||||||
临床1期 | 28 | Telm (Telm/Amlo 80 mg/10 mg) | 觸鏇艱製網網鏇襯願網(餘衊繭繭遞鹹觸廠夢齋) = 鏇繭膚糧鏇遞淵觸夢遞 鹽淵積蓋壓憲窪網膚膚 (觸鑰窪膚憲衊廠膚繭願, 60.8717) 更多 | - | 2012-03-16 | ||
Telm (Telm 80 mg + Amlo 10 mg) | 觸鏇艱製網網鏇襯願網(餘衊繭繭遞鹹觸廠夢齋) = 觸製艱製襯鏇簾齋廠鬱 鹽淵積蓋壓憲窪網膚膚 (觸鑰窪膚憲衊廠膚繭願, 66.1935) 更多 |
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