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
Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fasted Conditions
- First Posted Date
- 2012-10-23
- Last Posted Date
- 2018-01-23
- Lead Sponsor
- Roxane Laboratories
- Target Recruit Count
- 33
- Registration Number
- NCT01712113
- Locations
- 🇺🇸
Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research), San Antonio, Texas, United States
Crossover Bioequivalence Study of Irbesartan Hydrochlorothiazide 300/25 mg Tablets Under Fed Conditions
- Conditions
- Hypertension
- Interventions
- First Posted Date
- 2012-10-23
- Last Posted Date
- 2018-01-23
- Lead Sponsor
- Roxane Laboratories
- Target Recruit Count
- 40
- Registration Number
- NCT01712126
- Locations
- 🇺🇸
Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research), San Antonio, Texas, United States
Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis
- Conditions
- Focal Segmental Glomerulosclerosis
- Interventions
- Drug: RE-021 (Sparsentan)
- First Posted Date
- 2012-06-06
- Last Posted Date
- 2025-05-15
- Lead Sponsor
- Travere Therapeutics, Inc.
- Target Recruit Count
- 109
- Registration Number
- NCT01613118
- Locations
- 🇺🇸
Temple University School of Medicine, Philadelphia, Pennsylvania, United States
🇺🇸Marshfield Clinic Research Foundation, Marshfield, Wisconsin, United States
🇺🇸University of Washington, Seattle, Washington, United States
Preeclampsia: A Marker for Future Cardiovascular Risk in Women
- Conditions
- Pregnancy Induced HypertensionPreeclampsia
- Interventions
- First Posted Date
- 2012-01-26
- Last Posted Date
- 2019-01-17
- Lead Sponsor
- Brigham and Women's Hospital
- Target Recruit Count
- 150
- Registration Number
- NCT01519297
- Locations
- 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia
- Conditions
- HypertensionHyperlipidemia
- Interventions
- Drug: Irbesartan/Atorvastatin ADrug: PlaceboDrug: Irbesartan/Atorvastatin B
- First Posted Date
- 2011-09-29
- Last Posted Date
- 2013-08-13
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Target Recruit Count
- 230
- Registration Number
- NCT01442987
- Locations
- 🇰🇷
16 institutions including Seoul National University Hospital, Seoul, Korea, Republic of
The Effect of Moxonidine on Blood Pressure and Regression of Early Target Organ Damage in Young Subjects With Abdominal Obesity and Hypertension
- First Posted Date
- 2011-05-26
- Last Posted Date
- 2012-02-03
- Lead Sponsor
- Baker Heart and Diabetes Institute
- Target Recruit Count
- 100
- Registration Number
- NCT01360710
- Locations
- 🇦🇺
BakerIDI Heart and Diabetes Institute, Prahran, Victoria, Australia
Irbesartan Versus Amlodipine: The OBI Study
- First Posted Date
- 2009-10-01
- Last Posted Date
- 2014-02-11
- Lead Sponsor
- Aristotle University Of Thessaloniki
- Registration Number
- NCT00987662
- Locations
- 🇬🇷
Hypertension-24h ABPM Center Papageorgiou Hospital, Thessaloniki, Greece
Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy
- First Posted Date
- 2009-08-12
- Last Posted Date
- 2010-10-26
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 435
- Registration Number
- NCT00957554
- Locations
- 🇲🇽
Sanofi-Aventis Investigational Site Number 48401, Mérida, Mexico
🇲🇽Sanofi-Aventis Investigational Site Number 48407, San Luis Potosi, Mexico
🇨🇴Sanofi-Aventis Investigational Site Number 17003, Cartagena, Colombia
Irbesartan and Amlodipine Combination in Controlling Blood Pressure
- Conditions
- Hypertension
- Interventions
- First Posted Date
- 2009-07-31
- Last Posted Date
- 2011-01-05
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 270
- Registration Number
- NCT00950066
- Locations
- 🇨🇳
Sanofi-Aventis Administrative Office, Taipei, Taiwan
Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts
- Conditions
- Kidney Transplantation
- Interventions
- Drug: Corticosteroids
- First Posted Date
- 2009-07-07
- Last Posted Date
- 2024-11-01
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 281
- Registration Number
- NCT00933231
- Locations
- 🇨🇦
Site CA133 Foothills Medical Centre, Calgary, Alberta, Canada
🇨🇦Site CA54 University of Alberta Hospital, Edmonton, Alberta, Canada
🇨🇦Site CA27 London Health Sciences Centre, London, Ontario, Canada
Drug Development Updates
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