Delving into the Latest Updates on Amlodipine besilate/valsartan/hydrochlorothiazide with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Amlodipine Besylate/Valsartan/Hydrochlorothiazide, Amlodipine besylate/valsartan/hydrochlorothiazide, Amlodipine/Valsartan/Hydrochlorothiazide

+ [4]

Target

AT1R x NCC x VDCCs

Action

antagonists, inhibitors, blockers

Mechanism

AT1R antagonists(Angiotensin II Receptor Type 1 antagonists), NCC inhibitors(Thiazide-sensitive sodium-chloride cotransporter inhibitors), VDCCs blockers(Voltage-gated calcium channel blockers)

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Essential HypertensionHypertension

Inactive Indication-

Originator Organization

Novartis Pharma AG

Active Organization

Novartis Europharm Ltd.

Novartis AG

Novartis Pharmaceuticals Corp.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

United States (30 Apr 2009),

Hypertension

Regulation-

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Structure/Sequence

Molecular FormulaC57H68Cl2N10O15S3

InChIKeyDEUYZXPBTVNVGM-NNUMAELLSA-N

CAS Registry1315609-13-2

The creole study is a A Multi-centre, multinational, randomised single-blind, parallel group, three-armed superiority trial which is aimed at comparing the efficacy of three "free" combinations of two anti-hypertensive agents on 24 hour ambulatory systolic blood pressure (ASBP) in black African hypertensive patients.

Start Date07 Jun 2017

Sponsor / Collaborator

University of Abuja

[+7]

NCT00931710

/ CompletedPhase 4

A 12-week Multicenter, Randomized, Double-blind, Parallel-group, Active-control Study to Evaluate the Antihypertensive Efficacy and Safety of Valsartan/Amlodipine-based Regimen Versus a Losartan-based Regimen in Patients With Stage 2 Systolic Hypertension

This study will compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and less than 200 mmHg).

Start Date01 Jul 2009

Sponsor / Collaborator

Novartis AG

100 Clinical Results associated with Amlodipine besilate/valsartan/hydrochlorothiazide

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100 Translational Medicine associated with Amlodipine besilate/valsartan/hydrochlorothiazide

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100 Patents (Medical) associated with Amlodipine besilate/valsartan/hydrochlorothiazide

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2

Literatures (Medical) associated with Amlodipine besilate/valsartan/hydrochlorothiazide

01 Sep 2014·American Journal of Therapeutics

Azilsartan, Aliskiren, and Combination Antihypertensives Utilizing Renin–Angiotensin–Aldosterone System Antagonists

Review

Author: Aronow, Wilbert S ; Sankholkar, Kedar ; Lanier, Gregg

Health care providers managing hypertension (HTN) have a large selection of pharmacologic agents to choose from, including several different classes of drugs and many similar drugs within each class. Antagonism of the renin-angiotensin-aldosterone system has been shown to be very effective for HTN, especially in patients with cardiovascular disease, diabetes, and heart failure. Within this group, there have been 2 new agents recently introduced to the US market and approved by the Food and Drug Administration. It is important for the HTN specialist to be familiar with the merits of these 2 drugs: the angiotensin receptor blocker Edarbi (azilsartan) and the renin inhibitor Tekturna (aliskiren). Additionally, there have been several new, fixed-dose combination antihypertensives introduced to the market since 2006 that use a renin-angiotensin-aldosterone antagonist. Seven of these combine 2 drugs together in a single pill: Edarbyclor (azilsartan/chlorthalidone), Exforge (amlodipine/valsartan), Azor (olmesartan/amlodipine), Twynsta (amlodipine/telmisartan), Tekturna HCT [aliskiren/hydrochlorothiazide (HCTZ)], Valturna (aliskiren/valsartan), Tekamlo (aliskiren/amlodipine). Three triple-drug combination medications have also been introduced recently: Exforge HCT (amlodipine/valsartan/HCTZ), Tribenzor (olmesartan/amlodipine/HCTZ), and Amturnide (aliskiren/amlodipine/hydrocholorothiazide). This review will summarize the trial data and important pharmacologic merits of these 2 new renin-angiotensin-aldosterone antagonists and the advantages of initiating treatment with one of the new fixed-dose, combination drugs approved over the last 5 years.

Revue medicale de Liege

[Medication of the month. Exforge HCT: combination of amlodipine besylate, valsartan and hydrochlorothiazide in a single tablet].

Article

Author: Lancellotti, P

Because of the multifactorial nature of hypertension, most patients require combination therapy to achieve blood pressure control. Very often the antihypertensive regimen includes a renin-angiotensin system blocker, a calcium channel blocker, and a diuretic. Currently, several associations combining two antihypertensive agents with complementary mechanisms of action are available. These combination therapies are more efficient to control blood pressure through synergistic and additive effects, can reach target blood pressure more quickly, are likely to attenuate the side effects of each molecule, and could improve patient adherence. Exforge HCT is the first fixed-dose combination of three antihypertensive drugs including amlodipine besylate, valsartan and hydrochlorothiazide (HCTZ) in a single pill. The association of these three drugs improves, with an equal tolerance, blood pressure control compared to dual therapies (valsartan/HCTZ, amlodipine/valsartan, or HCTZ/amlodipine). This triple therapy attenuates the diuretic-induced hypokalemia. The benefits of triple therapy over dual therapy are observed regardless of age, sex, race, ethnicity, or baseline mean sitting systolic blood pressure. Exforge HCT is currently indicated for the treatment of essential hypertension, as replacement therapy for adult patients whose blood pressure is adequately controlled by the combination of amlodipine, valsartan and HCTZ.

100 Deals associated with Amlodipine besilate/valsartan/hydrochlorothiazide

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	C09DX01	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Essential Hypertension	Liechtenstein	Novartis Europharm Ltd.	15 Oct 2009
Essential Hypertension	Iceland	Novartis Europharm Ltd.	15 Oct 2009
Essential Hypertension	Norway	Novartis Europharm Ltd.	15 Oct 2009
Essential Hypertension	European Union	Novartis Europharm Ltd.	15 Oct 2009
Hypertension	United States	Novartis Pharmaceuticals Corp.	30 Apr 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypertension	Discovery	India	Novartis AG	01 Sep 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2018	Phase 3	Edema	2,268	Amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCTZ)	vcoszmjxee(midgqbineo) = fjuztehulz wflstrdbmx (inegzplboh )	-	26 Aug 2018
				Valsartan/amlodipine (Val/Aml)	vcoszmjxee(midgqbineo) = bviwijjlmf wflstrdbmx (inegzplboh )
[PP.27.20] (ESH2016)	Not Applicable	Hypertension	1,080	Amlodipine/valsartan/hydrochlorothiazide 5/160/12.5 mg	tdqjajioag(epyeimiifj) = ndutrmjvsz ngcvmpwdfh (fxspvwlpox ) View more	Positive	01 Sep 2016
				Amlodipine/valsartan/hydrochlorothiazide 10/160/25 mg	ttoxhjpjtz(vuvjylqkqr) = mygziqybes fkpkcnixjy (bogxemjzus ) View more
NCT00931710 (EXALT, CTgov)	Phase 4	Hypertension	488	valsartan, amlodipine, HCTZ (Valsartan/Amlodipine/HCTZ)	rzqvlmgtvt(maimskisqc) = idrmwpalpc bopwmzzlsb (vyrmwjrzex, roetainglm - oviwjmdavt) View more	-	04 Feb 2011
				Losartan, HCTZ+HCTZ+valsartan, amlodipine (Losartan/HCTZ)	rzqvlmgtvt(maimskisqc) = lvfktpvydo bopwmzzlsb (vyrmwjrzex, kryuityxzf - dzconkovbw) View more