Delving into the Latest Updates on Irbesartan/Amlodipine Besylate with Synapse

主要研究目的：考察单次单剂量口服（空腹）受试制剂厄贝沙坦氨氯地平片【规格：每片含厄贝沙坦100mg与苯磺酸氨氯地平5mg (按C20H25CIN2O5计)，杭州沐源生物医药科技有限公司持有】与参比制剂厄贝沙坦氨氯地平片【Aimix®，规格：每片含厄贝沙坦100mg和氨氯地平5mg，大日本住友製薬株式会社持证】，在中国健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性，为该药的申报及临床用药提供参考依据。次要研究目的：评价空腹单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。

[Translation]

Main research purpose: To investigate the single-dose oral (fasting) test preparation of irbesartan and amlodipine tablets [Specification: Each tablet contains 100 mg of irbesartan and 5 mg of amlodipine besylate (calculated as C20H25CIN2O5), Hangzhou Held by Muyuan Biomedical Technology Co., Ltd.] and the reference preparation irbesartan and amlodipine tablets [Aimix®, specifications: each tablet contains 100 mg of irbesartan and 5 mg of amlodipine, owned by Dainippon Sumitomo Co., Ltd. Certificate], relative bioavailability in healthy human subjects in China, analyzing the pharmacokinetic parameters of the two preparations, and evaluating the bioequivalence of the two preparations, to provide a reference basis for the application and clinical use of the drug. Secondary study objectives: To evaluate the safety of the test and reference preparations administered as a single oral dose on an empty stomach in Chinese adult healthy subjects.

Start Date10 Dec 2024

Sponsor / Collaborator

Hangzhou Muyuan Biomedical Technology Co., Ltd.

CTIS2024-511705-31-00

/ RecruitingPhase 3

A Greek multicenter, single-arm, low-intervention clinical trial to evaluate the efficacy and safety of irbesartan/amlodipine fixed combination in newly diagnosed patients or patients with uncontrolled arterial hypertension. - AMIR-FDC

Start Date26 Sep 2024

Sponsor / Collaborator-

CTR20232886

/ CompletedPhase 3

一项多中心、随机、双盲、双模拟的Ⅲ期临床研究，评价厄贝沙坦氨氯地平片（100mg/10mg；100mg/5mg）用于厄贝沙坦片单药（150mg）治疗4周血压不能有效控制的原发性轻、中度高血压患者的安全性和有效性

[Translation] A multicenter, randomized, double-blind, double-dummy Phase III clinical study to evaluate the safety and efficacy of irbesartan amlodipine tablets (100mg/10mg; 100mg/5mg) in patients with primary mild to moderate hypertension whose blood pressure cannot be effectively controlled by irbesartan tablets alone (150mg) for 4 weeks

评价厄贝沙坦氨氯地平片（100mg/10mg；100mg/5mg）用于厄贝沙坦片（150mg）单药治疗4周后血压控制不佳的原发性轻、中度高血压患者的安全性和有效性；为厄贝沙坦氨氯地平片在国内上市提供依据

[Translation]

To evaluate the safety and efficacy of irbesartan amlodipine tablets (100mg/10mg; 100mg/5mg) in patients with primary mild to moderate hypertension whose blood pressure is poorly controlled after 4 weeks of irbesartan tablets (150mg) monotherapy; to provide a basis for the marketing of irbesartan amlodipine tablets in China

Start Date23 Oct 2023

Sponsor / Collaborator

Beijing Baiao Pharmaceuticals Co., Ltd.

100 Clinical Results associated with Irbesartan/Amlodipine Besylate

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100 Translational Medicine associated with Irbesartan/Amlodipine Besylate

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100 Patents (Medical) associated with Irbesartan/Amlodipine Besylate

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2

Literatures (Medical) associated with Irbesartan/Amlodipine Besylate

01 Apr 2013·American Journal of Cardiovascular DrugsQ4 · MEDICINE

Irbesartan/Amlodipine: A Review of its Use in Adult Patients with Essential Hypertension Not Adequately Controlled with Monotherapy

Q4 · MEDICINE

Review

Author: Garnock-Jones, Karly P

Combination therapy is often required in patients with hypertension, and fixed-dose single-pill combinations have been shown to provide an easier regimen for patients, improving adherence. Irbesartan/amlodipine (Aprovasc®) is an angiotensin-receptor blocker/calcium-channel blocker fixed-dose single-pill combination, whose constituent drugs exert additive effects when coadministered. In two randomized, open-label, multicentre, phase III trials, fixed-dose combination therapy with irbesartan/amlodipine was more effective than continuation of irbesartan or amlodipine monotherapy in patients with hypertension not adequately controlled with initial irbesartan or amlodipine monotherapy; there was a significantly greater decrease from baseline in mean seated home systolic blood pressure (primary endpoint) with the fixed-dose combination. The fixed-dose combination was also associated with a greater decrease in mean seated home diastolic blood pressure and mean seated office systolic and diastolic blood pressure than monotherapy. The fixed-dose combination of irbesartan/amlodipine was well tolerated in these patients; most treatment-emergent adverse events were of mild or moderate severity. The most frequent adverse event was peripheral oedema, generally associated with amlodipine treatment.

01 Jan 2013·Folia Pharmacologica Japonica

Pharmacological and clinical properties of AIMIX^|^#174; combination tablets LD^|^amp;HD, fixed-dose combination of irbesartan and amlodipine besilate

Review

Author: Shino Takahashi ; Masaya Mori

A review on the current status of the treatment of hypertension; development of Aimix combination tablets containing angiotensin receptor blocker irbesartan (IRB) and calcium channel blocker amlodipine (AML); pharmacol. actions of IRB alone, AML alone, and IRB plus AML; and clin. efficacy and adverse effects of Aimix LD (IRB/AML 100 mg/5 mg) and HD (IRB/AML 100 mg/10 mg) in the treatment of essential hypertension.

100 Deals associated with Irbesartan/Amlodipine Besylate

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	C09DB05	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension	JP	Sumitomo Pharma Co., Ltd.	28 Sep 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypertension	Phase 2	CO	Sanofi	01 Jul 2009
Essential Hypertension	Phase 1	KR	Handok, Inc.	21 May 2020
Hypertension	Phase 1	MX	Sanofi	01 Jul 2009
Hypertension	Phase 1	TN	Sanofi	01 Jul 2009
Hypertension	Phase 1	EG	Sanofi	01 Jul 2009
Hypertension	Phase 1	CL	Sanofi	01 Jul 2009
Hypertension	Phase 1	VE	Sanofi	01 Jul 2009
Hypertension	Phase 1	BR	Sanofi	01 Jul 2009
Hypertension	Phase 1	MA	Sanofi	01 Jul 2009
Hypertension	Discovery	LB	Sanofi	01 Jul 2009

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05476354 \| NCT05475665 (I-DUO 301;I-DUO 302, Pubmed)	Phase 3	Essential Hypertension	428	Irbesartan/Amlodipine (IRB/AML 150/5 mg)	(ozfhirzsqu) = wsokpdwpno agydfpfbgz (hwsfqcdibe, 12.35)	Positive	01 Jun 2024
				Irbesartan/Amlodipine (IRB/AML 150/10 mg)	(ozfhirzsqu) = ropfqjunlj agydfpfbgz (hwsfqcdibe, 12.78)
ON-TRACK STUDY (ESH2023)	Not Applicable	Hypertension	1,012	Irbesartan/Amlodipine 150/5	lmcyjkarsz(dwkslxlxqf) = Adverse events were reported in 22.3 % of patients mainly oedema in 11 % of cases. None of the patients in the study reported a serious adverse event that would have led to discontinuation of treatment ysbpsppthf (pcprslrobp )	Positive	01 Jun 2023
				Irbesartan/Amlodipine 300/5
ASAHI AI STUDY (ESH2018)	Not Applicable	-	-	Irbesartan 100 mg/Amlodipine 10 mg	avtbyjpisx(patdsusofo) = etendnvgwl alwvzwkfnh (iefesyjxou, 13/11)	Positive	01 Jun 2018
				Indapamide 1 mg + ARBs + Amlodipine 5 mg	avtbyjpisx(patdsusofo) = onhdpvatwc alwvzwkfnh (iefesyjxou, 16/12)
PARCERIA STUDY (ESH2018)	Not Applicable	Hypertension	509	Amlodipine/Irbesartan fixed combination	iwgrcefeaw(kbpzgvlfzx) = There were 124 Treatment Emergent Adverse Events (TEAEs) experienced by 89 (17.5%) patients, including 7 serious TEAEs by 5 (1.0%) patients. TEAEs were not related to A/I (76.6%) rqqfazhyxo (vxtejtvrhj )	Positive	01 Jun 2018
ASAHI AI STUDY (ESH2017)	Not Applicable	-	-	Irbesartan 100 mg/Amlodipine 10 mg	(qvqcdabdzc) = mlopojcqmj ckantvuqep (pjjtskthkj, 8/13) View more	Positive	01 Sep 2017
				Indapamide 1 mg + ARBs + Amlodipine 5 mg	(qvqcdabdzc) = yalemmpjat ckantvuqep (pjjtskthkj, 11/13) View more