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Fuji
Queensland Health
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UBS
Teva
Boehringer Ingelheim
Federal Trade Commission
Fish and Richardson

Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR IRBESARTAN

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Clinical Trials for Irbesartan

Trial ID Title Status Sponsor Phase Summary
NCT00005010 Prevention of Kidney Transplant Rejection Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 The purpose of this study is to see how effective 2 drugs, irbesartan and pravastatin, are at slowing kidney transplant failure. Many kidney transplant patients have some type of chronic rejection. Chronic rejection is a disease that causes scarring and damage to the kidney. Over time, chronic rejection can lead to kidney failure, making it necessary for patients to start dialysis and possibly receive another kidney transplant. Doctors would like to see whether irbesartan and pravastatin can slow this damage and prevent kidney failure in patients with signs of chronic rejection.
NCT00065559 Treatment of Diabetic Nephropathy Terminated National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) N/A COX-2 is an enzyme that is found in several different tissues in the body. COX-2 appears to produce a substance called prostaglandins, mainly at sites of inflammation. Several drugs have been approved by the FDA that inhibit COX-2 such as celecoxib, or brand name Celebrex®. These drugs are primarily used in patients with osteoarthritis and rheumatoid arthritis to decrease inflammation and pain. COX-2 inhibitors have been developed because they are more selective in treatment of inflammation and pain and tend to have fewer gastrointestinal side effects than NSAIDs (nonsteroidal anti-inflammatory drugs) such as aspirin, ibuprofen, naproxen, etc. The normal adult kidney expresses COX-2 in various regions. Prostaglandins, which are produced in the kidney by COX-2, may contribute to glomerular and tubulointerstitial inflammatory diseases (types of kidney diseases due to inflammation). In some animal studies, COX-2 inhibitors have been shown to be potentially beneficial in reducing the amount of protein spilled in the urine and preserving kidney function with these inflammatory kidney diseases. This study will compare the effects of COX-2 inhibitor to placebo (an inactive substance) in patients with diabetic nephropathy (kidney disease due to diabetes) and proteinuria (spilling protein in the urine) on 24-hour urinary protein excretion. This study is designed to see whether COX-2 inhibitors are useful in treating diabetic patients with kidney disease. The purpose of this study is a short-term pilot study that will allow the gathering of important data such as the ability to carry out the study and carry it out safely. Subjects with proteinuria and diabetic kidney disease already on ACE (Angiotensin-Converting Enzyme) inhibitor or ARB (Angiotensin Receptor Blocker) therapy (types of blood pressure medicines) will be randomized to a type of study in which each subject will serve as their own control. The study is set up so that each subject will receive either the COX-2 inhibitor or placebo for a period followed by a period of no drug and then followed by a period of receiving either the COX-2 inhibitor or placebo (whichever they did not receive the first period).
NCT00095238 Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve) Completed Sanofi Phase 3 The purpose of this clinical research study is to learn if Irbesartan is superior to placebo in reducing mortality and cardiovascular morbidity in subjects with heart failure with preserved systolic function. The safety of this treatment will also be studied.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Irbesartan

Condition Name

Condition Name for Irbesartan
Intervention Trials
Hypertension 46
Diabetic Nephropathy 10
Atrial Fibrillation 5
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Condition MeSH

Condition MeSH for Irbesartan
Intervention Trials
Hypertension 28
Kidney Diseases 15
Diabetic Nephropathies 15
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Clinical Trial Locations for Irbesartan

Trials by Country

Trials by Country for Irbesartan
Location Trials
United States 141
Canada 34
Germany 20
Mexico 16
Australia 15
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Trials by US State

Trials by US State for Irbesartan
Location Trials
Texas 9
New Jersey 9
Illinois 7
North Carolina 6
Florida 5
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Clinical Trial Progress for Irbesartan

Clinical Trial Phase

Clinical Trial Phase for Irbesartan
Clinical Trial Phase Trials
Phase 4 40
Phase 3 29
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Irbesartan
Clinical Trial Phase Trials
Completed 67
Unknown status 9
Recruiting 8
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Clinical Trial Sponsors for Irbesartan

Sponsor Name

Sponsor Name for Irbesartan
Sponsor Trials
Sanofi 38
Bristol-Myers Squibb 27
Novartis 5
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Sponsor Type

Sponsor Type for Irbesartan
Sponsor Trials
Industry 90
Other 64
NIH 3
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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Cerilliant
Covington
Daiichi Sankyo
US Department of Justice
Merck
Express Scripts
Chinese Patent Office
UBS

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