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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

Remission Clinic in Proteinuric Chronic Nephropathies

Conditions
Chronic Kidney Disease
Interventions
First Posted Date
2016-03-29
Last Posted Date
2022-02-16
Lead Sponsor
Mario Negri Institute for Pharmacological Research
Target Recruit Count
1500
Registration Number
NCT02721342
Locations
🇮🇹

Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò, Ranica, Bergamo, Italy

🇮🇹

Ospedale Campo di Marte - USL 2 - U.O. Nefrologia, Lucca, Italy

🇮🇹

Ospedale di Circolo Fondazione Macchi - U.O. Nefrologia e Dialisi, Varese, Italy

and more 10 locations

A Prospective, Single-center, Randomized, Controlled Study of Sevelamer Carbonate in the Lipid Metabolism and Uric Acid Treatment of Obesity-Related Glomerulopathy

Not Applicable
Terminated
Conditions
Obesity and Glomerulopathy
Interventions
Drug: Low dosage Sevelamer Carbonate + Irbesartan
Drug: High dosage Sevelamer Carbonate + Irbesartan
First Posted Date
2015-12-31
Last Posted Date
2018-10-02
Lead Sponsor
Zhi-Hong Liu, M.D.
Target Recruit Count
4
Registration Number
NCT02644486
Locations
🇨🇳

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, Jiangsu, China

Angiotensin II Receptor Blockade in Vascular Ehlers Danlos Syndrome (ARCADE)

Phase 3
Completed
Conditions
Ehlers-Danlos Syndrome, Vascular Type
Interventions
Drug: Placebo
First Posted Date
2015-11-05
Last Posted Date
2024-02-29
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
61
Registration Number
NCT02597361
Locations
🇫🇷

CHU DE BORDEAUX - Hopital Saint Andre, Bordeaux, France

🇫🇷

CHU DE LYON - Hopital Femme Mere Enfant, Bron, France

🇫🇷

CHU DE TOURS - Hopital Trousseau, Chambray-les-Tours, France

and more 12 locations

Effectiveness of Avapro in Obese Normotensive/Hypertensive African Americans

Phase 2
Conditions
Blood Pressure
Hypertension
Obesity
Stress, Psychological
Interventions
Other: Placebo
First Posted Date
2015-03-11
Last Posted Date
2019-06-21
Lead Sponsor
Augusta University
Target Recruit Count
30
Registration Number
NCT02386293
Locations
🇺🇸

Augusta University, Augusta, Georgia, United States

Angiotensin II Antagonist in Severe Sepsis

Phase 3
Conditions
Severe Sepsis
Interventions
First Posted Date
2013-11-25
Last Posted Date
2013-11-25
Lead Sponsor
University of Salerno
Target Recruit Count
300
Registration Number
NCT01992796
Locations
🇮🇹

Università di Salerno, Salerno, Italy

The Oxford Marfan Trial

First Posted Date
2013-09-24
Last Posted Date
2015-06-09
Lead Sponsor
University of Oxford
Target Recruit Count
56
Registration Number
NCT01949233
Locations
🇬🇧

University of Oxford, Oxford, Oxfordshire, United Kingdom

🇬🇧

John Radcliffe Hospital, Oxford, Oxfordshire, United Kingdom

Drug Interaction Between Irbesartan and Hydrochlorothiazide

Not Applicable
Completed
Conditions
Healthy
Interventions
Drug: Irbeasartan/hydrochlorothiazide
First Posted Date
2013-05-21
Last Posted Date
2013-05-27
Lead Sponsor
Damanhour University
Target Recruit Count
18
Registration Number
NCT01858610
Locations
🇪🇬

Pharmaceutics Department, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt

Pharmacokinetic Drug Interaction Study Between Gemigliptin and Irbesartan After Oral Administration in Healthy Male Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2013-04-08
Last Posted Date
2014-12-30
Lead Sponsor
LG Life Sciences
Target Recruit Count
30
Registration Number
NCT01825850
Locations
🇰🇷

Asan Medical Center, Seoul, Korea, Republic of

Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fed Conditions

Not Applicable
Completed
Conditions
Hypertension
Interventions
First Posted Date
2012-10-23
Last Posted Date
2018-01-23
Lead Sponsor
Roxane Laboratories
Target Recruit Count
34
Registration Number
NCT01712100
Locations
🇺🇸

Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research), San Antonio, Texas, United States

Crossover Bioequivalence Study of Irbesartan HCTZ 300/25 mg Tablets Under Fasted Conditions

Not Applicable
Completed
Conditions
Hypertension
Interventions
First Posted Date
2012-10-23
Last Posted Date
2018-01-23
Lead Sponsor
Roxane Laboratories
Target Recruit Count
37
Registration Number
NCT01712139
Locations
🇺🇸

Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research), San Antonio, Texas, United States

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