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Last Updated: May 20, 2022

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
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 Dinitrate

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.
NCT00337116 ↗ Intravenous Isosorbide Dinitrate Versus Sublingual Isosorbide Dinitrate for the Relief of Acute Anginal Episodes in Acute Coronary Syndrome (ACS) Patients Withdrawn Soroka University Medical Center Phase 4 2007-01-01 This is a randomized, double blind, placebo-controlled study, clinical trail designed to evaluate the efficacy safety and superiority of intravenous boluses of isosorbide dinitrate for the relief of acute anginal pain episodes in acute coronary syndrome patients in comparison with the usual manner of S/L isosorbide dinitrate .
NCT00685945 ↗ Renin-Angiotensin Aldosterone System and Fibrinolysis Interaction in Humans-Specific Aim 3 Completed National Center for Research Resources (NCRR) N/A 2007-12-01 The purpose of the study is to determine if giving isosorbide,a drug that is used to treat chest pain, affects blood vessel release of an anti-clotting factor.
NCT00685945 ↗ Renin-Angiotensin Aldosterone System and Fibrinolysis Interaction in Humans-Specific Aim 3 Completed National Heart, Lung, and Blood Institute (NHLBI) N/A 2007-12-01 The purpose of the study is to determine if giving isosorbide,a drug that is used to treat chest pain, affects blood vessel release of an anti-clotting factor.
NCT00685945 ↗ Renin-Angiotensin Aldosterone System and Fibrinolysis Interaction in Humans-Specific Aim 3 Completed National Institutes of Health (NIH) N/A 2007-12-01 The purpose of the study is to determine if giving isosorbide,a drug that is used to treat chest pain, affects blood vessel release of an anti-clotting factor.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Isosorbide Dinitrate

Condition Name

Condition Name for Isosorbide Dinitrate
Intervention Trials
Heart Failure 5
Congestive Heart Failure 2
Acute Heart Failure 2
Cardio-Renal Syndrome 2
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Condition MeSH

Condition MeSH for Isosorbide Dinitrate
Intervention Trials
Heart Failure 8
Myocardial Ischemia 3
Heart Diseases 3
Coronary Disease 3
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Clinical Trial Locations for Isosorbide Dinitrate

Trials by Country

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

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

Clinical Trial Phase

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

Clinical Trial Status for Isosorbide Dinitrate
Clinical Trial Phase Trials
Completed 15
Unknown status 5
Recruiting 3
[disabled in preview] 5
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Clinical Trial Sponsors for Isosorbide Dinitrate

Sponsor Name

Sponsor Name for Isosorbide Dinitrate
Sponsor Trials
National Institutes of Health (NIH) 2
National Heart, Lung, and Blood Institute (NHLBI) 2
National Institute of Perinatology 1
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Sponsor Type

Sponsor Type for Isosorbide Dinitrate
Sponsor Trials
Other 43
NIH 6
Industry 5
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Serving leading biopharmaceutical companies globally:

Moodys
Mallinckrodt
Baxter
McKesson
Boehringer Ingelheim
AstraZeneca

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