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
Clinical Trial of Keluoxin Capsules in the Treatment of Diabetic Kidney Disease with Diabetic Retinopathy
- Conditions
- Diabetic Kidney DiseaseDiabetic Retinopathy
- Interventions
- First Posted Date
- 2024-10-28
- Last Posted Date
- 2024-10-28
- Lead Sponsor
- Chinese PLA General Hospital
- Target Recruit Count
- 460
- Registration Number
- NCT06660940
A Study of the Effect and Safety of HS-10390 in the Treatment of Patients with Primary IgA Nephropathy
- Conditions
- Immunoglobulin a Nephropathy
- Interventions
- First Posted Date
- 2024-10-10
- Last Posted Date
- 2024-10-10
- Lead Sponsor
- Hansoh BioMedical R&D Company
- Target Recruit Count
- 90
- Registration Number
- NCT06635772
The Predictive Role of Urinary Proteomics in Blood Pressure Response of Obese Hypertensive Treated With Irbesartan or Eplerenone.
- Conditions
- Primary HypertensionObesity
- Interventions
- First Posted Date
- 2024-01-17
- Last Posted Date
- 2024-01-17
- Lead Sponsor
- Hippocration General Hospital
- Target Recruit Count
- 50
- Registration Number
- NCT06208072
- Locations
- 🇬🇷
Hypertension Unit, A' University Cardiology Clinic, Hippocration General Hospital of Athens, Athens, Greece
Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects
- Conditions
- Therapeutic Equivalency
- Interventions
- First Posted Date
- 2023-03-27
- Last Posted Date
- 2023-03-27
- Lead Sponsor
- The Affiliated Hospital of Qingdao University
- Target Recruit Count
- 68
- Registration Number
- NCT05786339
- Locations
- 🇨🇳
Affiliated Hospital of Qingdao University Phase I Clinical Research Center, Qingdao, Shandong, China
Pharmacokinetics of Irbesartan High/Amlodipine FDC and Co-administration of Irbesartan High and Amlodipine in Healthy Volunteers
- Conditions
- Healthy Volunteers
- Interventions
- First Posted Date
- 2023-01-18
- Last Posted Date
- 2023-08-18
- Lead Sponsor
- Handok Inc.
- Target Recruit Count
- 44
- Registration Number
- NCT05688085
- Locations
- 🇰🇷
H Plus Yangji Hospital, Seoul, Korea, Republic of
Pharmacokinetics of Irbesartan/Amlodipine High FDC and Co-administration of Irbesartan and Amlodipine High in Healthy Volunteers
- Conditions
- Healthy Volunteers
- Interventions
- First Posted Date
- 2023-01-18
- Last Posted Date
- 2023-08-18
- Lead Sponsor
- Handok Inc.
- Target Recruit Count
- 44
- Registration Number
- NCT05688098
- Locations
- 🇰🇷
H Plus Yangji Hospital, Seoul, Korea, Republic of
Pharmacokinetics of Irbesartan/Amlodipine FDC and Co-administration of Irbesartan and Amlodipine in Healthy Volunteers
- Conditions
- Healthy Volunteers
- Interventions
- First Posted Date
- 2022-12-23
- Last Posted Date
- 2023-08-18
- Lead Sponsor
- Handok Inc.
- Target Recruit Count
- 46
- Registration Number
- NCT05663073
- Locations
- 🇰🇷
H Plus Yangji Hospital, Seoul, Korea, Republic of
Clinical Efficacy and Safety Evaluation of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients
- Conditions
- Essential Hypertension
- Interventions
- First Posted Date
- 2022-07-27
- Last Posted Date
- 2023-08-18
- Lead Sponsor
- Handok Inc.
- Target Recruit Count
- 271
- Registration Number
- NCT05476354
- Locations
- 🇰🇷
Severance Hospital, Seoul, Korea, Republic of
Clinical Efficacy and Safety Evaluation of Irbesartan High and Amlodipine Combined Therapy in Essential Hypertension Patients
- Conditions
- Essential Hypertension
- Interventions
- Drug: Irbesartan/Amlodipine
- First Posted Date
- 2022-07-27
- Last Posted Date
- 2023-08-18
- Lead Sponsor
- Handok Inc.
- Target Recruit Count
- 157
- Registration Number
- NCT05475665
- Locations
- 🇰🇷
Hanyang University Seoul Hospital, Seoul, Korea, Republic of
A Bioequivalence Trial of Irbesartan Tablets（0.15g） in Healthy Chinese Subjects
- Conditions
- Under Fed ConditionUnder Fasted ConditionIrbesartan Tablets (0.15g/Tablet)Bioequivalence
- Interventions
- First Posted Date
- 2022-03-28
- Last Posted Date
- 2022-03-28
- Lead Sponsor
- The Affiliated Hospital of Qingdao University
- Target Recruit Count
- 54
- Registration Number
- NCT05297929
- Locations
- 🇨🇳
The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China
Drug Development Updates
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