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Last Updated: July 2, 2020

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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 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 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.
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Sublingual Isosorbide Dinitrate for the Relief of Acute Anginal Episodes in Acute Coronary Syndrome (ACS) Patients Withdrawn Soroka University Medical Center Phase 4 2007-01-01 This is a randomized, double blind, placebo-controlled study, clinical trail designed to evaluate the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.
NCT00685945 Renin-Angiotensin Aldosterone System and Fibrinolysis Interaction in Humans-Specific Aim 3 Completed Vanderbilt University Medical Center 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.
NCT00803634 Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO) Completed The Medicines Company Phase 3 2008-12-01 The purpose of this study was to evaluate the efficacy and safety of intravenous (IV) clevidipine as compared with standard of care IV antihypertensive agents for blood pressure (BP) lowering in patients with acute heart failure and elevated BP.
>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
Cardio-Renal Syndrome 2
Non Small Cell Lung Cancer (NSCLC) 1
Diabetic Foot Ulcers 1
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Condition MeSH

Condition MeSH for Isosorbide Dinitrate
Intervention Trials
Heart Failure 7
Heart Diseases 3
Coronary Disease 3
Coronary Artery 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 32
China 3
South Africa 1
Hong Kong 1
Netherlands 1
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Trials by US State

Trials by US State for Isosorbide Dinitrate
Location Trials
Alabama 3
Ohio 3
Georgia 2
Florida 2
Massachusetts 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 6
Phase 3 5
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for Isosorbide Dinitrate
Clinical Trial Phase Trials
Completed 10
Recruiting 5
Active, not recruiting 4
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Clinical Trial Sponsors for Isosorbide Dinitrate

Sponsor Name

Sponsor Name for Isosorbide Dinitrate
Sponsor Trials
National Heart, Lung, and Blood Institute (NHLBI) 2
Arbor Pharmaceuticals, Inc. 1
Corporal Michael J. Crescenz VA Medical Center 1
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Sponsor Type

Sponsor Type for Isosorbide Dinitrate
Sponsor Trials
Other 33
NIH 5
Industry 4
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