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, Ciprofibrate and Their Combination Onto the Endothelial Functions

Phase 4
Completed
Conditions
Dyslipidemia
Hypertension
First Posted Date
2006-07-10
Last Posted Date
2008-01-23
Lead Sponsor
Sanofi
Target Recruit Count
60
Registration Number
NCT00350038
Locations
🇭🇺

Sanofi-aventis, Budapest, Hungary

Effect of Irbesartan on Insulin Sensitivity in Chronic Heart Failure

Phase 4
Completed
Conditions
Chronic Heart Failure
First Posted Date
2006-07-04
Last Posted Date
2007-10-31
Lead Sponsor
Charite University, Berlin, Germany
Target Recruit Count
36
Registration Number
NCT00347087
Locations
🇩🇪

Applied Cachexia Research, Cardiology Dept. Charite Medical School, Virchow Klinikum, Berlin, Germany

I SAVE - Irbesartan in Mild to Moderate Hypertensive Patients

Phase 4
Completed
Conditions
Hypertension
First Posted Date
2006-06-12
Last Posted Date
2011-04-01
Lead Sponsor
Sanofi
Target Recruit Count
1630
Registration Number
NCT00335673
Locations
🇪🇬

Sanofi-Aventis Administrative Office, Cairo, Egypt

Irbesartan in Chinese Hypertensive Diabetics With Microalbuminuria

Phase 4
Completed
Conditions
Hypertension
Interventions
First Posted Date
2006-06-08
Last Posted Date
2009-09-15
Lead Sponsor
Sanofi
Target Recruit Count
192
Registration Number
NCT00334581
Locations
🇨🇳

Sanofi-Aventis Administrative Office, Shanghai, China

Optimal Dose of Irbesartan for Renoprotection in Type 2 Diabetic Patients With Persistent Microalbuminuria

Phase 4
Completed
Conditions
Type 2 Diabetes
Microalbuminuria
First Posted Date
2006-05-03
Last Posted Date
2006-05-18
Lead Sponsor
Steno Diabetes Center Copenhagen
Target Recruit Count
52
Registration Number
NCT00320879
Locations
🇩🇰

Steno Diabetes Center, Gentofte, Copenhagen, Denmark

Irbesartan in Type 2 Diabetes

Phase 3
Completed
Conditions
Type 2 Diabetes
Microalbuminuria
Hypertension
First Posted Date
2006-04-25
Last Posted Date
2006-04-25
Lead Sponsor
Steno Diabetes Center Copenhagen
Registration Number
NCT00317915

ARCHIPELAGO: Irbesartan in Patients With Acute Coronary Syndrome Without ST Segment Elevation

Phase 3
Completed
Conditions
Myocardial Ischemia
Hypertension
First Posted Date
2006-02-24
Last Posted Date
2009-10-15
Lead Sponsor
Sanofi
Target Recruit Count
440
Registration Number
NCT00296218
Locations
🇬🇧

Sanofi-Aventis, Guildford, United Kingdom

APROVE : Irbesartan in Hypertension

Phase 4
Completed
Conditions
Hypertension
First Posted Date
2006-01-27
Last Posted Date
2008-04-03
Lead Sponsor
Sanofi
Target Recruit Count
200
Registration Number
NCT00283036
Locations
🇩🇿

Sanofi-Aventis, Alger, Algeria

Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C

Phase 3
Completed
Conditions
Hepatitis C, Chronic
Interventions
Drug: placebo
First Posted Date
2005-12-15
Last Posted Date
2014-02-07
Lead Sponsor
ANRS, Emerging Infectious Diseases
Target Recruit Count
166
Registration Number
NCT00265642
Locations
🇫🇷

CHU Angers, Service d'hépato-gastroentérologie, Angers, France

Irbesartan in Hypertension

Phase 4
Completed
Conditions
Hypertension
Interventions
First Posted Date
2005-12-15
Last Posted Date
2009-12-07
Lead Sponsor
Sanofi
Target Recruit Count
88
Registration Number
NCT00265967
Locations
🇹🇷

Sanofi-Aventis, Istanbul, Turkey

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