18 completed, 6 terminated, 2 unknown, 2 withdrawn. 28 Phase 2, 4 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 28 | Completed 18, Terminated 6, Unknown 2, Withdrawn 2 |
| Phase 1 | 4 | Completed 2, Terminated 2 |
| Phase 3 | 2 | Completed 2 |
Follow Sodium Nitrite: new trials by email Literature Review of Sodium Nitrite trials Research Report on Sodium Nitrite
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Oral Nitrite Trial for Hypertension and Metabolic Syndrome 14 Nitrogen (N) Sodium Nitrite, Placebo - Metabolic Syndrome, Hypertension | Phase 2 | Withdrawn | Gladwin, Mark, MD | 2020-10-01 | 2021-04-19 | |
| Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite Sodium Nitrite, Normal Saline - COVID-19, Acute Respiratory Distress Syndrome | Phase 2 | Withdrawn | Hope Pharmaceuticals | 2020-07-22 | 2020-09-16 | |
| The Nitrite and Coronary Flow Study Sodium Nitrite - Cardiovascular Diseases, Vasodilation | Phase 1 / Phase 2 | Completed | University of East Anglia | 14 | 2018-07-01 | 2020-04-21 |
| Topical Sodium Nitrite in Sickle Cell Disease and Leg Ulcers Topical Sodium Nitrite, Placebo - Sickle Cell Disease | Phase 2 | Terminated | caterina P minniti | 18 | 2018-04-06 | 2025-05-07 |
| Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest Placebo, sodium nitrite 45 mg, sodium nitrite 60 mg - Out-Of-Hospital Cardiac Arrest | Phase 2 / Phase 3 | Completed | University of Washington | 1502 | 2018-02-08 | 2023-05-24 |
| Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction Sodium Nitrite, Placebo Oral Capsule - Pulmonary Hypertension Secondary, Heart Failure | Phase 2 | Completed | University of Pittsburgh | 33 | 2017-10-30 | 2024-06-07 |
| Oral Nitrite for Older Heart Failure With Preserved Ejection Fraction sodium nitrite, Control - Heart Failure | Phase 2 | Completed | Gladwin, Mark, MD | 15 | 2017-04-03 | 2020-01-22 |
| Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF) (INABLE-Training) Placebo, Sodium Nitrite, Accelerometer - Heart Failure | Phase 2 | Completed | Barry Borlaug | 92 | 2016-09-01 | 2023-04-26 |
| Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis sodium nitrite - Cystic Fibrosis | Phase 1 / Phase 2 | Terminated | Schmidhofer, Mark, MD | 4 | 2016-02-01 | 2024-06-24 |
| Oral Nitrite for Older Heart Failure Patients 14 N Sodium Nitrite - Heart Failure | Phase 2 | Completed | Gladwin, Mark, MD | 21 | 2016-01-08 | 2018-09-18 |
| The Effects of NOx and Conjugated Linoleic Acid on Asthmatics Conjugated Linolenic Acid, Sodium Nitrite, Sodium Nitrate - Asthma | Phase 2 | Completed | Gladwin, Mark, MD | 6 | 2015-09-01 | 2021-04-27 |
| A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain Sodium nitrite, Placebo - Diabetes | Phase 2 | Completed | TheraVasc Inc. | 26 | 2015-04-28 | 2020-04-24 |
| Inhaled Sodium Nitrite on Heart Failure With Preserved Ejection Fraction Sodium Nitrite Inhalation Solution, Placebo - Heart Failure | Phase 2 | Completed | Mayo Clinic | 26 | 2014-10-01 | 2017-08-29 |
| Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage Sodium Nitrite - Subarachnoid Hemorrhage | Phase 2 | Terminated | Hope Pharmaceuticals | 6 | 2014-06-01 | 2018-03-30 |
| Nitrite Effects on Cardiac Muscle in CABG Sodium Nitrite, 0.9% Sodium-chloride - Coronary Artery Disease, Atherosclerosis | Phase 2 | Unknown | University of East Anglia | 75 | 2013-01-21 | 2019-06-28 |
| A Phase 2 Study to Determine the Safety and Efficacy of AIR001 in Subjects With Pulmonary Arterial Hypertension (PAH) AIR001 (sodium nitrite inhalation solution) - Pulmonary Arterial Hypertension | Phase 2 | Terminated | Aires Pharmaceuticals, Inc. | 29 | 2012-11-01 | 2014-04-09 |
| Oral Nitrite in Adults With Metabolic Syndrome and Hypertension 14Nitrogen Sodium Nitrite - Metabolic Syndrome, Hypertension | Phase 2 | Completed | Gladwin, Mark, MD | 20 | 2012-10-01 | 2019-04-16 |
| Inhaled Nitrite in Subjects With Pulmonary Hypertension Inhaled Nitrite - Pulmonary Hypertension, Heart Failure, Diastolic | Phase 2 | Completed | Schmidhofer, Mark, MD | 48 | 2012-06-01 | 2019-03-28 |
| Safety and Effectiveness of Intra-coronary Nitrite in Acute Myocardial Infarction Sodium Nitrite, Sodium Chloride Placebo - Myocardial Infarction, Reperfusion Injury | Phase 2 | Completed | Barts & The London NHS Trust | 80 | 2012-04-01 | 2017-11-29 |
| Sodium Nitrite in Lung Transplant Patients to Minimize the Risk of Pulmonary Graft Dysfunction Sodium Nitrite - Primary Graft Dysfunction | Phase 2 | Terminated | Gladwin, Mark, MD | 3 | 2011-10-01 | 2018-08-01 |
Showing 20 of 28. Sign in to see all of them.
Heart Failure (6) · Anemia, Sickle Cell (2) · Aneurysm (2) · Cardiovascular Diseases (2) · Diabetes Mellitus (2) · Hypertension (2) · Metabolic Syndrome (2) · Reperfusion Injury (2) · Subarachnoid Hemorrhage (2) · Vascular Diseases (2) · Asthma (1) · Atherosclerosis (1) · COVID-19 (1) · Coronary Artery Disease (1) · Cystic Fibrosis (1)
Gladwin, Mark, MD (6) · Hope Pharmaceuticals (3) · Schmidhofer, Mark, MD (2) · TheraVasc Inc. (2) · University of East Anglia (2) · Aires Pharmaceuticals, Inc. (1) · Barry Borlaug (1) · Barts & The London NHS Trust (1) · Children's Hospital Los Angeles (1) · Johns Hopkins University (1) · Mayo Clinic (1) · National Heart, Lung, and Blood Institute (NHLBI) (1) · University Hospital Birmingham NHS Foundation Trust (1) · University of Aberdeen (1) · University of Colorado, Boulder (1)
United States (23) · United Kingdom (5) · Australia (1) · Hungary (1)
Mark Gladwin, MD (3) · Kara S Hughan, MD (2) · Adaani E Frost, M.D. (1) · Allison E DeVan, Ph.D. (1) · Amol Soin, PhD (1) · Anthony Mathur, FRCP, PhD (1) · Barry A Borlaug, MD (1) · Barry Borlaug, MD (1) · Caterina Minniti, M.D. (1) · Daniel E Forman, MD (1) · Daniel Forman, MD (1) · David HildickSmith, MD, FRCP (1) · Douglas R Seals, Ph.D. (1) · Edward Oldfield, MD (1) · Francis Kim, MD (1)
PMID 23550096, PMID 23648219, PMID 23706046, PMID 25512434, PMID 27458234, PMID 27683405, PMID 27812547, PMID 31599928, PMID 32755471, PMID 33421267, PMID 33433575, PMID 37565977, PMID 38127015
R01HL128526 (2), P01HL103455 (1), R01HL129722 (1), R44NS063485 (1), R56AG051637 (1), U10HL110262 (1)