DeepMed Research

Irbesartan

Generic Name: Irbesartan

Brand Names: Avalide, Avapro, Ifirmacombi, Karvea, Karvezide, Irbesartan Teva, Ifirmasta (previously Irbesartan Krka), Irbesartan Zentiva (previously Irbesartan Winthrop), Aprovel

Drug Type: Small Molecule

Chemical Formula: C_₂₅H_₂₈N_₆O

CAS Number: 138402-11-6

Unique Ingredient Identifier: J0E2756Z7N

Background: Irbesartan is an angiotensin receptor blocker (ARB) indicated to treat hypertension or diabetic nephropathy. It can also be used as part of a combination product with hydrochlorothiazide for patients not well controlled or not expected to be well controlled on monotherapy. Unlike angiotensin converting enzyme inhibitors, ARBs are not associated with a dry cough.

Irbesartan was granted FDA approval on 30 September 1997.

Indication: Irbesartan is indicated to treat hypertension and diabetic nephropathy in hypertensive patients with type 2 diabetes, elevated serum creatinine, and proteinuria. A combination product with hydrochlorothiazide is indicated for hypertension in patients with uncontrolled hypertension with monotherapy or first line in patients not expected to be well controlled with monotherapy.

Associated Conditions: Diabetic Nephropathy, Hypertension

Clinical Trials

Randomized, Parallel, Comparison, Double-Blind Efficacy & Safety Study of APROVEL Versus Placebo in Chinese Patients With Hypertensive Type II Diabetic Patients With Microalbuminuria

Phase 3

Completed

Conditions: Hypertension

Interventions: Drug: Irbesartan
Drug: placebo

First Posted Date: 2007-11-21

Last Posted Date: 2007-11-26

Lead Sponsor: Sanofi

Target Recruit Count: 241

Registration Number: NCT00561964

Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol

Phase 4

Completed

Conditions: Hypertension
Diabetes Mellitus Type 2

First Posted Date: 2007-10-25

Last Posted Date: 2007-10-25

Lead Sponsor: Sanofi

Target Recruit Count: 44

Registration Number: NCT00549133

Locations: 🇹🇷
Sanofi-Aventis, Istanbul, Turkey

Nephropathy In Type 2 Diabetes and Cardio-renal Events

Phase 4

Completed

Conditions: Diabetic Nephropathy

Interventions: Drug: SoC therapy
Drug: irbesartan
Drug: ramipril
Drug: hydrochlorothiazide
Drug: furosemide
Drug: amlodipine
Drug: atenolol
Drug: doxazosin
Drug: clonidine
Drug: insulin
Drug: simvastatin
Drug: fibrate
Drug: erythropoietin
Drug: aspirin

First Posted Date: 2007-09-27

Last Posted Date: 2020-08-03

Lead Sponsor: University of Campania "Luigi Vanvitelli"

Target Recruit Count: 850

Registration Number: NCT00535925

Locations: 🇮🇹
Department of Advanced Medical and Surgical Sciences, Università della Campania "Luigi Vanvitelli", Naples, Italy, Naples, Italy

Effect of the Angiotensin II Receptor Antagonist Irbesartan on Biochemical and Functional Markers of Endothelial Dysfunction in Patients With Hypertension

Phase 4

Completed

Conditions: Hypertension

Interventions: Drug: IRBESARTAN
Drug: Atenolol

First Posted Date: 2007-09-14

Last Posted Date: 2011-01-12

Lead Sponsor: Sanofi

Target Recruit Count: 108

Registration Number: NCT00529750

Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan

Phase 4

Conditions: Antihypertensive Drugs
Left Atrial Volume
Hypertensive Heart Disease
Diastolic Function
Renin Angiotensin System

Interventions: Drug: irbesartan
Drug: ramipril

First Posted Date: 2007-08-16

Last Posted Date: 2007-08-16

Lead Sponsor: Università degli Studi dell'Insubria

Target Recruit Count: 80

Registration Number: NCT00517322

Locations: 🇮🇹
University of Insubria-Department of Clinical Medicine, Varese, Italy

Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing

Phase 4

Completed

Conditions: Hypertension

Interventions: Drug: Irbesartan/Hydrochlorothiazide
Drug: Irbesartan

First Posted Date: 2007-03-06

Last Posted Date: 2009-10-01

Lead Sponsor: Sanofi

Target Recruit Count: 60

Registration Number: NCT00443612

Locations: 🇨🇳
Sanofi-Aventis, Taipei, Taiwan

Irbesartan and Atenolol in Hypertensive Heart Disease

Phase 2

Completed

Conditions: Hypertension

Interventions: Drug: Irbesartan
Drug: Atenolol

First Posted Date: 2006-10-18

Last Posted Date: 2015-05-05

Lead Sponsor: Karolinska Institutet

Target Recruit Count: 115

Registration Number: NCT00389168

Locations: 🇸🇪
Karolinska Institutet, Daprtment of Clinical Sciences, Danderyd Hospital, Cardiovascular Research Laboratory, Stockholm, Sweden

I SELECT - Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy

Phase 4

Completed

Conditions: Hypertension

First Posted Date: 2006-08-09

Last Posted Date: 2011-05-30

Lead Sponsor: Sanofi

Target Recruit Count: 281

Registration Number: NCT00362037

Locations: 🇪🇬
Sanofi-Aventis Administrative Office, Cairo, Egypt

I PREVENT - Irbesartan In Hypertensive Diabetic Patients

Phase 4

Completed

Conditions: Hypertension

First Posted Date: 2006-08-09

Last Posted Date: 2011-04-04

Lead Sponsor: Sanofi

Target Recruit Count: 797

Registration Number: NCT00362258

Locations: 🇪🇬
Sanofi-Aventis Administrative Office, Cairo, Egypt

Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)

Phase 3

Completed

Conditions: Atrial Fibrillation

Interventions: Drug: Placebo
Drug: Irbesartan

First Posted Date: 2006-07-14

Last Posted Date: 2010-02-17

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 44

Registration Number: NCT00352560

Locations: 🇪🇸
Local Institution, Madrid, Spain

Drug Development Updates

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