[Translation] A randomized, double-blind, double-dummy, multicenter phase III clinical study on the efficacy and safety of levamlodipine benazepril capsules (2.5mg/10mg) in patients with primary mild to moderate hypertension whose blood pressure cannot be effectively controlled by benazepril hydrochloride tablets (10mg) alone for 4 weeks.

验证复方制剂相对于单方制剂的优效性：评价左氨氯地平贝那普利胶囊（2.5mg /10mg）用于盐酸贝那普利片（10 mg）单药治疗4周血压不能有效控制的原发性轻、中度高血压患者的有效性和安全性。

[Translation]

To verify the superiority of the combination preparation over the single preparation: To evaluate the efficacy and safety of levoamlodipine benazepril capsules (2.5 mg/10 mg) in patients with primary mild to moderate hypertension whose blood pressure cannot be effectively controlled by benazepril hydrochloride tablets (10 mg) alone for 4 weeks.

Start Date04 Sep 2024

Sponsor / Collaborator

Jiangxi Shimei Pharmaceutical Co., Ltd.

CTR20241495 / Active, not recruitingNot ApplicableIIT

氨氯地平贝那普利胶囊在健康受试者中随机、开放、单剂量、两制剂、交叉对照空腹及餐后状态下的生物等效性研究

[Translation] A randomized, open-label, single-dose, two-formulation, crossover controlled bioequivalence study of amlodipine and benazepril capsules in healthy volunteers under fasting and fed conditions

研究空腹及餐后状态下单次口服受试制剂氨氯地平贝那普利胶囊（规格：氨氯地平/盐酸贝那普利5mg/10mg，浙江恒研医药科技有限公司持证）与参比制剂氨氯地平贝那普利胶囊（商品名：LOTREL®，规格：氨氯地平/盐酸贝那普利5mg/10mg，Novartis Pharmaceuticals Corp持证）在健康成年受试者体内的药代动力学，评价空腹及餐后状态下口服两种制剂的生物等效性。

[Translation]

The pharmacokinetics of the test preparation amlodipine benazepril capsules (specifications: amlodipine/benazepril hydrochloride 5mg/10mg, licensed by Zhejiang Hengyan Pharmaceutical Technology Co., Ltd.) and the reference preparation amlodipine benazepril capsules (trade name: LOTREL®, specifications: amlodipine/benazepril hydrochloride 5mg/10mg, licensed by Novartis Pharmaceuticals Corp) were studied in healthy adult subjects after a single oral administration in fasting and fed state, and the bioequivalence of the two preparations after oral administration in fasting and fed state was evaluated.

Start Date26 May 2024

Sponsor / Collaborator

Zhejiang Hengyan Pharmaceutical Technology Co., Ltd.

CTR20241205 / CompletedNot Applicable

氨氯地平贝那普利胶囊（5mg:10mg）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两制剂、交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-formulation, crossover bioequivalence study of amlodipine benazepril capsules (5 mg:10 mg) in Chinese healthy subjects under fasting and fed conditions

主要研究目的：按有关生物等效性试验的规定，选择Novartis Pharmaceuticals Corp.为持证商的氨氯地平贝那普利胶囊（商品名：Lotrel®，规格：5mg:10mg）为参比制剂，对兰西哈三联制药有限公司生产，安徽万邦医药科技股份有限公司提供的受试制剂氨氯地平贝那普利胶囊（规格：5mg:10mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，比较两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂氨氯地平贝那普利胶囊（规格：5mg:10mg）和参比制剂氨氯地平贝那普利胶囊（商品名：Lotrel®，规格：5mg:10mg）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, amlodipine benazepril capsules (trade name: Lotrel®, specifications: 5mg:10mg) with Novartis Pharmaceuticals Corp. as the licensee were selected as the reference preparation, and the test preparation amlodipine benazepril capsules (specifications: 5mg:10mg) produced by Lanxiha Sanlian Pharmaceutical Co., Ltd. and provided by Anhui Wanbang Pharmaceutical Technology Co., Ltd. were subjected to human bioequivalence test for fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to compare the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation amlodipine benazepril capsules (specifications: 5mg:10mg) and the reference preparation amlodipine benazepril capsules (trade name: Lotrel®, specifications: 5mg:10mg) by healthy volunteers.

Start Date02 May 2024

Sponsor / Collaborator

Anhui Wanbang Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Amlodipine Besylate/Benazepril Hydrochloride

100 Translational Medicine associated with Amlodipine Besylate/Benazepril Hydrochloride

100 Patents (Medical) associated with Amlodipine Besylate/Benazepril Hydrochloride

Literatures (Medical) associated with Amlodipine Besylate/Benazepril Hydrochloride

01 Sep 2022·Annals of Palliative Medicine

Hypertension as a rare adverse effect caused by infliximab in the treatment of Crohn’s disease: a case report

Author: Tang, Jian ; Zhao, Xiying ; Mo, Jiahao ; Zhang, Beiping

BACKGROUNDInfliximab is an effective drug for the treatment of Crohn's disease. As a rare and unique adverse effect of infliximab, hypertension should be paid enough attention in clinical work. At present, there is no relevant case report. We report a case of a 38-year-old man with Crohn's disease who had no history of hypertension and developed hypertension symptoms during infliximab treatment.CASE DESCRIPTIONThe patient was treated with 5 mg/kg infliximab on August 27, 2020. From August 27, 2020 to October 20, 2020, the patient underwent 3 treatment sessions. After each injection of infliximab, the patient's blood pressure became elevated, accompanied by dizziness and symmetrical numbness of both lower limbs. Amlodipine benazepril tablets were given orally to control blood pressure. Under close monitoring, 5 mg/kg infliximab was used again. After 10 min of infusion, blood pressure rose to 160/118 mmHg. Infusion was discontinued immediately, after which blood pressure decreased to normal. Adrenal computed tomography did not indicate adrenal hyperplasia or space occupying lesions, and the detection of hypertension related indicators in standing and supine position was abnormal. Since follow up, the patient has stopped using infliximab and has had no hypertension-related symptoms, even without antihypertensives. Measured blood pressure was within the normal range.CONCLUSIONSHypertension, as one of the rare adverse reactions of infliximab in the treatment of Crohn's disease, should be paid enough attention.

01 Jul 2013·American Journal of HypertensionQ3 · MEDICINE

Dynamic View on Affordability of Fixed-Dose Combination Antihypertensive Drug Therapy

Q3 · MEDICINE

Article

Author: Junling Wang ; Song Hee Hong ; Jun Tang

BACKGROUNDThe use of fixed-dose combinations (FDCs) has been increasing since the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure recommended using ≥2 drugs as the first-line drug therapy for patients with stage 2 hypertension. FDCs simplify the drug therapy regimen and reportedly lower the drug therapy cost compared with the free combination (FC) of 2 single-agent drugs. This study hypothesized that the affordability of FDCs over FCs would change over time depending on the availability of generic single-agent drugs.METHODSThis study used the 2009 Medical Expenditure Panel Survey. Antihypertensive drugs were identified based on the Food and Drug Administration national drug directory. Based on the 2 databases, regression models were run to predict average monthly drug cost as well as out-of-pocket cost for each prescription along with their 95% confidence intervals (CIs).RESULTSOverall, FDCs (n = 26) had average monthly drug costs similar to respective FCs when FCs were not generically available. However, when FCs were generically available, FDCs (n = 11) had average drugs costs much higher than their respective FCs. For example, Lotrel as an FDC had an average monthly drug cost of $115.97 (95% CI = $96.59-$135.36), whereas its counterpart FC had an average monthly drug cost of $21.00 (95% CI = $18.23-$23.79).CONCLUSIONSThe cost advantage of FDCs over FCs was reversed when FCs were generically available. The finding of this study informs patients, health-care providers, and drug plans of the importance of making dynamic decisions on preferred drug therapy options depending on the availability of generic drugs.

01 Jun 2011·Expert Review of Cardiovascular Therapy

Renoprotective effects of benazepril: current perspective

Review

Author: Olszewski, Artur ; Stompoor, Tomasz ; Napora, Maria

Cardiovascular (CV) disease, its associated risk factors and continued progression run in parallel with renal deterioration (cardio-renal syndrome). Most guidelines promote early treatment, including the use of ACE inhibitors to control CV risk in patients with chronic renal failure. The renoprotective effects of the ACE inhibitor, benazepril, independent of blood pressure control, have been demonstrated, as monotherapy or in combination with amlodipine or hydrochlorothiazide, in large clinical trials: Avoiding Cardiovascular Events through Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) and Gauging Albuminuria Reduction with Lotrel in Diabetic Patients with Hypertension (GUARD) in patients with mild-to-severe chronic kidney disease. In the ACCOMPLISH trial, CV outcomes and renoprotective effects were greater in patients receiving benazepril in combination with amlodipine; the GUARD trial demonstrated that combined benazepril/hydrochlorothiazide was more effective than amlodipine combined with benazepril in reducing baseline urinary albumin:creatinine ratio and normalizing urinary albumin:creatinine ratio in patients with baseline microalbuminuria, although this effect was accompanied with a greater decrease in glomerular filtration rate than with benazepril/amlodipine. While this is not a study in patients with overt renal disease (patients had severe CV diseases), the ACCOMPLISH trial is the first large study to date to show the added benefit of combining ACE inhibitors and calcium-channel blockers in renal protection. Future large, well-controlled trials, designed to evaluate hard renal outcomes, are required to identify which patients will benefit most from particular combination treatment strategies in renoprotection.

News (Medical) associated with Amlodipine Besylate/Benazepril Hydrochloride

21 May 2007

·www.biospace.com

Teva Pharmaceutical Industries Limited Provides Update on Generic Lotrel® Litigation

JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the United States District Court for the District of New Jersey has vacated a temporary order restraining Teva's launch of its amlodipine besylate/benazepril products, AB rated to Novartis' Lotrel®. Instead, the Court has ordered Teva and Novartis not to sell or offer further generic product, beyond what has already been commercialized, including any authorized generics, until at least the completion of a status call with the Judge next Tuesday, May 29, 2007.

Generic Drug

100 Deals associated with Amlodipine Besylate/Benazepril Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	Amlodipine Besylate/Benazepril Hydrochloride	C02N	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension	US	Sandoz, Inc.	03 Mar 1995

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypertension	Phase 2	CN	Furen Medicines Group Co., Ltd.	11 Sep 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01375322 (Pubmed \| Med Lett Drugs Ther)	Phase 4	Diabetes Mellitus, Type 2 \| Hypertension	226	Amlodipine/Benazepril	amfnxftplj(dyifkgvmxk) = more frequently reported in the amlodipine/benazepril group than in the valsartan/hydrochlorothiazide group vgibyaoykm (yowbuvxmhg )	-	01 Aug 2012
NCT00170950 (ACCOMPLISH, CTgov)	Phase 3	Hypertension	11,506	Benazepril/amlodipine 20/5 mg - Dose Level 1 from Day 1 to Month 1 (Benazepril/Amlodipine)	ryeqftywfd(kkjqstmitg) = zcnqmanlxs gdehzlcsnw (mgrrldivtp, rmncufcttk - iwtyvikxnr) View more	-	17 May 2011
NCT00170950 (ACCOMPLISH, CTgov)	Phase 3	Hypertension	11,506	Benazepril/hydrochlorothiazide 40/12.5 mg - Dose Level 2 from Month 1 to Month 2 (Benazepril/Hydrochlorothiazide)	ryeqftywfd(kkjqstmitg) = knivyoghia gdehzlcsnw (mgrrldivtp, slzczrhgma - osjgegakbs) View more	-	17 May 2011

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