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Last Updated: May 16, 2021

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CLINICAL TRIALS PROFILE FOR ISOSORBIDE

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505(b)(2) Clinical Trials for Isosorbide

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Indication NCT01478022 To Compare the Pharmacokinetics Profiles of ISO 20, IBU 200 and IBU Plus ISO Combinations 200 + 20 Unknown status Parent Project, Italy Phase 1 2011-10-01 This study will evaluate the pharmacokinetics plasma profile of 3 treatments: ISO 20, IBU 200 and IBU and ISO combinations (200 +20) given in single dose. This study is being conducted to support the submission for new indication in treatment of the combinations of Isosorbide Dinitrate and Ibuprofen as a treatment for Duchenne muscular dystrophy.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Isosorbide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000478 Asymptomatic Cardiac Ischemia Pilot (ACIP) Study Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1990-11-01 To assess the feasibility of and test the methodology for a full-scale clinical trial of therapies for asymptomatic cardiac ischemia.
NCT00143195 Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina Completed Pfizer Phase 4 2001-04-01 The objective of study is to compare the anti-ischemic efficacy and safety profiles of once daily amlodipine or isosorbide-5-mononitrate in the treatment of stable asymptomatic and symptomatic myocardial ischemia
NCT00168519 Contraction (Exercise) Mediated Glucose Uptake as a Therapeutic Target in Type 2 Diabetes Completed Diabetes Australia N/A 2002-10-01 The purpose of this project is to determine whether glucose metabolism can be improved by administering a substance (nitric oxide donor) normally released by muscles during exercise.
NCT00168519 Contraction (Exercise) Mediated Glucose Uptake as a Therapeutic Target in Type 2 Diabetes Completed Hoffmann-La Roche N/A 2002-10-01 The purpose of this project is to determine whether glucose metabolism can be improved by administering a substance (nitric oxide donor) normally released by muscles during exercise.
NCT00168519 Contraction (Exercise) Mediated Glucose Uptake as a Therapeutic Target in Type 2 Diabetes Completed National Health and Medical Research Council, Australia N/A 2002-10-01 The purpose of this project is to determine whether glucose metabolism can be improved by administering a substance (nitric oxide donor) normally released by muscles during exercise.
NCT00168519 Contraction (Exercise) Mediated Glucose Uptake as a Therapeutic Target in Type 2 Diabetes Completed Baker Heart Research Institute N/A 2002-10-01 The purpose of this project is to determine whether glucose metabolism can be improved by administering a substance (nitric oxide donor) normally released by muscles during exercise.
NCT00252421 The Nitrate and Bone Study: Effects of Nitrates on Osteoporosis Completed Canadian Institutes of Health Research (CIHR) Phase 3 2005-10-01 Osteoporosis or "thinning of the bones" affects in 1 in 4 Canadian women and 1 in 8 Canadian men. Moreover, while the rates of osteoporosis among Canadians are stabilizing, worldwide the number of people afflicted with osteoporosis continues to rise. The most serious complication of osteoporosis is a broken bone or fracture. Fractures due to osteoporosis can result in long hospital stays, dependence on others, and premature death. While there are several medications that prevent osteoporosis they all have side effects. For example, postmenopausal women who take hormone replacement therapy (HRT) are at increased risk of breast cancer and heart disease. In addition, drugs to prevent osteoporosis are expensive and not available worldwide. Therefore, it is essential that researchers continue to identify and test new medications for the prevention of osteoporosis. The purpose of the research is to determine if nitrates, a group of drugs that are widely available, inexpensive, and commonly used to treat chest pain or angina, can prevent osteoporosis in women. If the researchers find that nitrates prevent osteoporosis, a widely available, inexpensive treatment for osteoporosis prevention that does not have any long term side effects would have been identified. This will improve the health of patients with osteoporosis worldwide.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Isosorbide

Condition Name

Condition Name for Isosorbide
Intervention Trials
Hypertension 6
Heart Failure 6
Healthy 5
Myocardial Ischemia 3
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Condition MeSH

Condition MeSH for Isosorbide
Intervention Trials
Heart Failure 8
Coronary Artery Disease 6
Myocardial Ischemia 6
Hypertension 5
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Clinical Trial Locations for Isosorbide

Trials by Country

Trials by Country for Isosorbide
Location Trials
United States 41
Egypt 8
China 6
Denmark 5
India 3
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Trials by US State

Trials by US State for Isosorbide
Location Trials
Pennsylvania 4
Massachusetts 3
Georgia 3
Texas 3
Illinois 2
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Clinical Trial Progress for Isosorbide

Clinical Trial Phase

Clinical Trial Phase for Isosorbide
Clinical Trial Phase Trials
Phase 4 13
Phase 3 14
Phase 2/Phase 3 2
[disabled in preview] 39
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Clinical Trial Status

Clinical Trial Status for Isosorbide
Clinical Trial Phase Trials
Completed 32
Not yet recruiting 13
Recruiting 11
[disabled in preview] 13
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Clinical Trial Sponsors for Isosorbide

Sponsor Name

Sponsor Name for Isosorbide
Sponsor Trials
Cairo University 4
Danish Headache Center 3
National Heart, Lung, and Blood Institute (NHLBI) 3
[disabled in preview] 9
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Sponsor Type

Sponsor Type for Isosorbide
Sponsor Trials
Other 85
Industry 19
NIH 6
[disabled in preview] 2
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Serving leading biopharmaceutical companies globally:

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