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Last Updated: June 26, 2022

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 Completed 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
NCT00143195 ↗ Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina Completed Pfizer's Upjohn has merged with Mylan to form Viatris Inc. 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Isosorbide

Condition Name

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

Condition MeSH for Isosorbide
Intervention Trials
Heart Failure 9
Hypertension 6
Myocardial Ischemia 6
Coronary Artery Disease 6
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Clinical Trial Locations for Isosorbide

Trials by Country

Trials by Country for Isosorbide
Location Trials
United States 43
Egypt 11
Denmark 6
China 6
India 3
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Trials by US State

Trials by US State for Isosorbide
Location Trials
Pennsylvania 5
Ohio 3
Massachusetts 3
Georgia 3
Texas 3
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Clinical Trial Progress for Isosorbide

Clinical Trial Phase

Clinical Trial Phase for Isosorbide
Clinical Trial Phase Trials
Phase 4 15
Phase 3 14
Phase 2/Phase 3 2
[disabled in preview] 12
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Clinical Trial Status

Clinical Trial Status for Isosorbide
Clinical Trial Phase Trials
Completed 42
Unknown status 12
Terminated 4
[disabled in preview] 4
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Clinical Trial Sponsors for Isosorbide

Sponsor Name

Sponsor Name for Isosorbide
Sponsor Trials
Cairo University 5
Merck Sharp & Dohme Corp. 3
National Heart, Lung, and Blood Institute (NHLBI) 3
[disabled in preview] 3
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Sponsor Type

Sponsor Type for Isosorbide
Sponsor Trials
Other 93
Industry 21
NIH 6
[disabled in preview] 2
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