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Last Updated: December 22, 2024

CLINICAL TRIALS PROFILE FOR ISOSORBIDE DINITRATE

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505(b)(2) Clinical Trials for ISOSORBIDE DINITRATE

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 DINITRATE

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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.
NCT00262470 ↗	Treatment of Orthostatic Intolerance	Active, not recruiting	National Institutes of Health (NIH)	Phase 1/Phase 2	1997-04-01	This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.
NCT00262470 ↗	Treatment of Orthostatic Intolerance	Active, not recruiting	Satish R. Raj	Phase 1/Phase 2	1997-04-01	This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Start Date	>Summary

Clinical Trial Conditions for ISOSORBIDE DINITRATE

Condition Name

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Condition Name for ISOSORBIDE DINITRATE
Intervention	Trials
Heart Failure	5
Cardio-Renal Syndrome	2
Congestive Heart Failure	2
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Condition MeSH

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Condition MeSH for ISOSORBIDE DINITRATE
Intervention	Trials
Heart Failure	8
Myocardial Ischemia	3
Heart Diseases	3
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Clinical Trial Locations for ISOSORBIDE DINITRATE

Trials by Country

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Trials by Country for ISOSORBIDE DINITRATE
Location	Trials
United States	33
China	3
Tunisia	2
Denmark	2
Iran, Islamic Republic of	1
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Trials by US State

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Trials by US State for ISOSORBIDE DINITRATE
Location	Trials
Ohio	3
Alabama	3
Tennessee	3
Georgia	2
Florida	2
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Clinical Trial Progress for ISOSORBIDE DINITRATE

Clinical Trial Phase

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Clinical Trial Phase for ISOSORBIDE DINITRATE
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	6
Phase 2	5
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Clinical Trial Status

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Clinical Trial Status for ISOSORBIDE DINITRATE
Clinical Trial Phase	Trials
Completed	15
Unknown status	5
Recruiting	3
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Clinical Trial Sponsors for ISOSORBIDE DINITRATE

Sponsor Name

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Sponsor Name for ISOSORBIDE DINITRATE
Sponsor	Trials
National Heart, Lung, and Blood Institute (NHLBI)	2
National Institutes of Health (NIH)	2
University of Monastir	1
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Sponsor Type

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Sponsor Type for ISOSORBIDE DINITRATE
Sponsor	Trials
Other	43
NIH	6
Industry	5
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