Last update 21 Nov 2024

Irbesartan/Amlodipine Besylate

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Amlodipine besilate/irbesartan, Amlodipine/irbesartan, Aprovasc

+ [6]

Target

AT1R x VDCCs

Mechanism

AT1R antagonists(Angiotensin II Receptor Type 1 antagonists), VDCCs blockers(Voltage-gated calcium channel blockers)

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Hypertension

Inactive Indication

Essential Hypertension

Originator Organization

Sanofi

Active Organization

Hunan Jiudian Pharmaceutical Co., Ltd.

Sumitomo Pharma Co., Ltd.

Beijing Baiao Pharmaceuticals Co., Ltd.

Inactive Organization

Jiangxi Shimei Pharmaceutical Co., Ltd.

Sanofi

Handok, Inc.

Drug Highest PhaseApproved

First Approval Date

JP (28 Sep 2012),

Hypertension

Regulation-

Structure

Molecular FormulaC26H31ClN2O8S

InChIKeyZPBWCRDSRKPIDG-UHFFFAOYSA-N

CAS Registry111470-99-6

View All Structures (2)

Clinical Trials associated with Irbesartan/Amlodipine Besylate

CTIS2024-511705-31-00 / Recruiting

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.

CTR20232888 / 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/5mg）用于苯磺酸氨氯地平片（5mg）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/5mg) in patients with primary mild to moderate hypertension whose blood pressure cannot be effectively controlled by amlodipine besylate tablets (5mg) alone for 4 weeks

评价厄贝沙坦氨氯地平片（100mg/5mg）用于苯磺酸氨氯地平片（5mg）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，为厄贝沙坦氨氯地平片在国内上市提供依据

[Translation]

To evaluate the efficacy and safety of irbesartan amlodipine tablets (100mg/5mg) in patients with primary mild to moderate hypertension whose blood pressure cannot be effectively controlled by amlodipine besylate tablets (5mg) alone for 4 weeks, and 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

100 Translational Medicine associated with Irbesartan/Amlodipine Besylate

100 Patents (Medical) associated with Irbesartan/Amlodipine Besylate

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

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	C09DB05	-

R&D Status

Approved

10 top approved records.

to view more data

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

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hypertension	Preclinical	CL	Sanofi	01 Jul 2009
Hypertension	Preclinical	AE	Sanofi	01 Jul 2009
Hypertension	Preclinical	MA	Sanofi	01 Jul 2009
Hypertension	Preclinical	EG	Sanofi	01 Jul 2009
Hypertension	Preclinical	TN	Sanofi	01 Jul 2009
Hypertension	Preclinical	VE	Sanofi	01 Jul 2009
Hypertension	Preclinical	MX	Sanofi	01 Jul 2009
Hypertension	Preclinical	LB	Sanofi	01 Jul 2009
Hypertension	Preclinical	RU	Sanofi	01 Jul 2009
Hypertension	Preclinical	CO	Sanofi	01 Jul 2009

Clinical Result

Indication

Phase

Evaluation

View All Results

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)	(etaarmhrld) = bqzjdrpvhr jxydwxgtvr (wvkzbluuki, 12.35)	Positive	01 Jun 2024
				Irbesartan/Amlodipine (IRB/AML 150/10 mg)	(etaarmhrld) = sekxpvhudh jxydwxgtvr (wvkzbluuki, 12.78)

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