MedPath

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
C25H28N6O
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

Irbesartan-Hydrochlorothiazide Phase IV Study: Treatment of Hypertension in Chinese Population

Phase 4
Completed
Conditions
Hypertension
Interventions
First Posted Date
2009-02-19
Last Posted Date
2009-09-15
Lead Sponsor
Sanofi
Target Recruit Count
968
Registration Number
NCT00847834
Locations
🇨🇳

Sanofi aventis administrative office, Beijing, China

Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan

Phase 3
Completed
Conditions
Kidney Failure, Chronic
Interventions
Drug: Placebo matching irbesartan 150 mg
First Posted Date
2008-11-17
Last Posted Date
2013-01-08
Lead Sponsor
University of Aarhus
Target Recruit Count
82
Registration Number
NCT00791830
Locations
🇩🇰

Department of Nephrology, Aarhus University Hospital, Skejby, Aarhus N, Denmark

🇩🇰

Department of Medicine, Fredericia Hospital, Fredericia, Denmark

🇩🇰

Haemodialysis unit, Horsens Hospital, Horsens, Denmark

and more 3 locations

Role of AT1-receptor Blockers in Insulin-induced Vasodilation.

Not Applicable
Conditions
Hypertension
Insulin Resistance
Microcirculation
Interventions
First Posted Date
2008-08-27
Last Posted Date
2011-03-17
Lead Sponsor
Maastricht University Medical Center
Target Recruit Count
32
Registration Number
NCT00742066
Locations
🇳🇱

University Hospital Maastricht, Maastricht, P.O. Box 5800, Netherlands

ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination

Phase 4
Completed
Conditions
Hypertension
Interventions
First Posted Date
2008-07-02
Last Posted Date
2010-07-16
Lead Sponsor
Sanofi
Target Recruit Count
832
Registration Number
NCT00708344
Locations
🇻🇪

Sanofi-Aventis Administrative Office, Caracas, Venezuela

A Clinical Study to Evaluate Renal Hemodynamic Responses to Aliskiren in Patients With Type 2 Diabetes Mellitus

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2008-04-17
Last Posted Date
2012-08-29
Lead Sponsor
Novartis
Target Recruit Count
45
Registration Number
NCT00660309
Locations
🇺🇸

Novartis Investigator Site, Boston, Massachusetts, United States

Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)

First Posted Date
2008-04-14
Last Posted Date
2019-12-03
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
151
Registration Number
NCT00657059
Locations
🇨🇳

The 1st Affiliated Hospital, Sun Yet-sen University, Guangzhou, Guangdong, China

A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension

Phase 2
Completed
Conditions
Hypertension
Interventions
First Posted Date
2008-03-13
Last Posted Date
2011-09-16
Lead Sponsor
Ligand Pharmaceuticals
Target Recruit Count
261
Registration Number
NCT00635232
Locations
🇺🇸

MD Medical Research, Oxon Hill, Maryland, United States

🇺🇸

East-West Medical Research Institute, Honolulu, Hawaii, United States

🇺🇸

Cedar Crosse Research Center, Chicago, Illinois, United States

and more 37 locations

Irbesartan and Adhesion Molecules in AF

Phase 4
Conditions
Persistent Atrial Fibrillation
Interventions
Drug: placebo
First Posted Date
2008-02-13
Last Posted Date
2009-05-29
Lead Sponsor
University of Magdeburg
Target Recruit Count
60
Registration Number
NCT00613496
Locations
🇩🇪

University Hospital Magdeburg; Div. of Cardiology, Magdeburg, Germany

Evaluation of Efficacy and Safety of the Dosage Adjustment of Aprovel® (Irbesartan) in Hypertensive Outpatients in Current Clinical Practice

Phase 4
Completed
Conditions
Hypertension
Interventions
First Posted Date
2007-11-27
Last Posted Date
2007-11-28
Lead Sponsor
Sanofi
Target Recruit Count
115
Registration Number
NCT00564187
Locations
🇹🇳

Sanofi-Aventis, Megrine, Tunisia

The Efficacy and Safety of Irbesartan 150/12.5 mg and 300/25 mg in Patients With Mild Hypertension

Phase 4
Completed
Conditions
Hypertension
First Posted Date
2007-11-22
Last Posted Date
2007-11-27
Lead Sponsor
Sanofi
Target Recruit Count
1005
Registration Number
NCT00562809
Locations
🇺🇸

Sanofi-Aventis, Bridgewater, New Jersey, United States

© Copyright 2025. All Rights Reserved by MedPath