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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

AMISH : Aprovel for Management of Isolated Systolic Hypertension

Phase 4
Completed
Conditions
Hypertension
First Posted Date
2005-12-12
Last Posted Date
2007-12-21
Lead Sponsor
Sanofi
Target Recruit Count
436
Registration Number
NCT00264212
Locations
🇹🇭

Sanofi-Aventis, Bangkok, Thailand

Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension

Phase 3
Completed
Conditions
Hypertension
First Posted Date
2005-12-07
Last Posted Date
2007-12-07
Lead Sponsor
Sanofi
Target Recruit Count
40
Registration Number
NCT00263003
Locations
🇨🇳

Sanofi-Aventis, Taipei, Taiwan

Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I)

Phase 3
Completed
Conditions
Atrial Fibrillation
Cardiovascular Disease
Interventions
Drug: placebo
First Posted Date
2005-11-07
Last Posted Date
2010-10-15
Lead Sponsor
Sanofi
Target Recruit Count
9016
Registration Number
NCT00249795
Locations
🇬🇧

Sanofi-Aventis Administrative Office, Guildford Surrey, United Kingdom

Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension and Permanent Pacemakers

Phase 3
Conditions
Atrial Fibrillation
Hypertension
First Posted Date
2005-09-26
Last Posted Date
2005-11-23
Lead Sponsor
Connolly, Stuart, M.D.
Target Recruit Count
200
Registration Number
NCT00225667
Locations
🇨🇦

Population Health Research Institute of McMaster University, Hamilton, Ontario, Canada

Characterization of Vascular Effects of Angiotensin II in Dorsal Human Hand Veins.

Not Applicable
Completed
Conditions
Healthy Subjects
First Posted Date
2005-09-16
Last Posted Date
2005-09-16
Lead Sponsor
Technische Universität Dresden
Registration Number
NCT00180024
Locations
🇩🇪

Institute of Clinical Pharmacology, Medical Faculty, University of Technology, Dresden, Germany

The Relative Effects of Olmesartan Medoxomil, Irbesartan and Valsartan on the Activity of the Blood Pressure Control System in Healthy Subjects

Phase 4
Completed
Conditions
Healthy
First Posted Date
2005-09-16
Last Posted Date
2005-09-16
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
20
Registration Number
NCT00185055

VALID: Study to Compare the Reduction of Predialysis Systolic Blood Pressure With Valsartan Compared to Irbesartan in Patients With Mild to Moderate Hypertension on Long-term Hemodialysis

Phase 3
Completed
Conditions
Hypertension
First Posted Date
2005-09-15
Last Posted Date
2017-05-18
Lead Sponsor
Novartis
Target Recruit Count
86
Registration Number
NCT00171080
Locations
🇨🇭

Novartis Pharmaceuticals, Basel, Switzerland

Comparison of Vascular Effects After Therapy With Irbesartan and Atorvastatin.

Not Applicable
Completed
Conditions
Healthy Subjects
First Posted Date
2005-09-12
Last Posted Date
2006-09-28
Lead Sponsor
Technische Universität Dresden
Registration Number
NCT00154024
Locations
🇩🇪

Institute of Clinical Pharmacology, Medical Faculty, University of Technology, Dresden, Germany

Effect of Irbesartan on Endothelial Function of the Retinal Vasculature in Patients With Hypercholesterolemia

Phase 3
Withdrawn
Conditions
Hypercholesterolemia
Interventions
First Posted Date
2005-09-09
Last Posted Date
2024-12-16
Lead Sponsor
University of Erlangen-Nürnberg Medical School
Target Recruit Count
80
Registration Number
NCT00152698
Locations
🇩🇪

CRC, Medizinsiche Klinik 4, Nephrology and Hypertension, University of Erlangen-Nürnberg, Erlangen, Bavaria, Germany

Left Ventricular Function After Acute Myocardial Infarction (AMI). Treatment With Angiotensin 2-Receptor Blockade (GLOBAL-Study)

Phase 4
Completed
Conditions
Myocardial Infarction
Interventions
First Posted Date
2005-08-01
Last Posted Date
2018-05-08
Lead Sponsor
University of Southern Denmark
Target Recruit Count
200
Registration Number
NCT00125645
Locations
🇩🇰

Kardiologisk Klinik, Centralsygehuset Esbjerg/Varde, Esbjerg, Denmark

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