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Last Updated: April 24, 2024

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

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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	>Sponsor	>Phase	>Start Date	>Summary

All Clinical Trials for isosorbide

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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	>Sponsor	>Phase	>Start Date	>Summary

Clinical Trial Conditions for isosorbide

Condition Name

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Condition Name for isosorbide
Intervention	Trials
Heart Failure	6
Hypertension	6
Healthy	5
Myocardial Ischemia	3
[disabled in preview]	0
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Condition MeSH

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Condition MeSH for isosorbide
Intervention	Trials
Heart Failure	9
Coronary Artery Disease	6
Hypertension	6
Myocardial Ischemia	6
[disabled in preview]	0
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Clinical Trial Locations for isosorbide

Trials by Country

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Trials by Country for isosorbide
Location	Trials
United States	43
Egypt	12
China	6
Denmark	6
India	3
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Trials by US State

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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

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Clinical Trial Phase for isosorbide
Clinical Trial Phase	Trials
Phase 4	16
Phase 3	14
Phase 2/Phase 3	2
[disabled in preview]	12
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Clinical Trial Status

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Clinical Trial Status for isosorbide
Clinical Trial Phase	Trials
Completed	43
Unknown status	12
Terminated	4
[disabled in preview]	4
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Clinical Trial Sponsors for isosorbide

Sponsor Name

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Sponsor Name for isosorbide
Sponsor	Trials
Cairo University	5
Danish Headache Center	3
Merck Sharp & Dohme Corp.	3
[disabled in preview]	3
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Sponsor Type

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Sponsor Type for isosorbide
Sponsor	Trials
Other	94
Industry	21
NIH	6
[disabled in preview]	2
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