24 completed, 7 terminated, 5 withdrawn, 4 unknown. 28 Phase 2, 14 Phase 1, 3 Phase 3, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 28 | Completed 18, Terminated 6, Unknown 2, Withdrawn 2 |
| Phase 1 | 14 | Completed 7, Terminated 3, Unknown 2, Withdrawn 2 |
| Phase 3 | 3 | Completed 2, Withdrawn 1 |
| Not applicable | 1 | Completed 1 |
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 |
|---|---|---|---|---|---|---|
| Effects of Sustained-release Oral Sodium Nitrite on Postoperative Pain and Recovery Following Total Knee Arthroplasty JAN101 SR, Placebo - Pain | Phase 1 | Withdrawn | University of Alabama at Birmingham | 2026-06-01 | 2025-06-24 | |
| Nitrite Infusion in Children With Malaria Sodium Nitrite - Falciparum Malaria | Phase 1 | Withdrawn | Duke University | 2021-06-01 | 2021-03-16 | |
| 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and Metabolic Syndrome 14 Nitrogen (N) Sodium Nitrite, Placebo - Metabolic Syndrome, Hypertension | Phase 2 | Withdrawn | Gladwin, Mark, MD | 2020-10-01 | 2021-04-19 | |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Intravenous Sodium Nitrite Sodium Nitrite, Normal Saline - COVID-19, Acute Respiratory Distress Syndrome | Phase 2 | Withdrawn | Hope Pharmaceuticals | 2020-07-22 | 2020-09-16 | |
| Nitrite Infusion in High Risk Patients Undergoing Cardiopulmonary Bypass Saline, Sodium Nitrite - Acute Kidney Injury | Phase 3 | Withdrawn | University of Alabama at Birmingham | 2018-10-01 | 2018-09-27 | |
| 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 |
| The Haem and Nitrite Study - The Effects of Haemoglobin NO-blockade on Nitrite-induced Forearm Vessel Dilatation Sodium Nitrite - Healthy Volunteers | Phase 1 | Unknown | University of East Anglia | 41 | 2016-12-01 | 2017-03-20 |
| Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest Sodium Nitrite - Out-Of-Hospital Cardiac Arrest | Phase 1 | Completed | University of Washington | 120 | 2016-12-01 | 2018-05-07 |
| 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 |
| The Effect of Sodium Nitrite on Renal Function and Blood Pressure in Hypertensive Versus Healthy Subjects Sodium nitrite, Sodium chloride - Hypertension | Phase 1 | Unknown | Erling Bjerregaard Pedersen | 30 | 2015-05-01 | 2015-08-19 |
| 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 |
| Nitrite Supplementation for Improving Physiological Function in Older Adults Sodium nitrite, Placebo - Ageing | Not applicable | Completed | University of Colorado, Boulder | 49 | 2015-03-01 | 2019-12-05 |
| 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 |
Showing 20 of 40. Sign in to see all of them.
Heart Failure (6) · Aneurysm (5) · Hypertension (4) · Anemia, Sickle Cell (3) · Cardiovascular Diseases (2) · Diabetes Mellitus (2) · Hypoxia (2) · Metabolic Syndrome (2) · Out-of-Hospital Cardiac Arrest (2) · Reperfusion Injury (2) · Subarachnoid Hemorrhage (2) · Vascular Diseases (2) · Acute Kidney Injury (1) · Asthma (1) · Atherosclerosis (1)
Gladwin, Mark, MD (6) · National Heart, Lung, and Blood Institute (NHLBI) (4) · Hope Pharmaceuticals (3) · University of East Anglia (3) · Erling Bjerregaard Pedersen (2) · Schmidhofer, Mark, MD (2) · TheraVasc Inc. (2) · University of Alabama at Birmingham (2) · University of Colorado, Boulder (2) · University of Washington (2) · Aires Pharmaceuticals, Inc. (1) · Barry Borlaug (1) · Barts & The London NHS Trust (1) · Children's Hospital Los Angeles (1) · Duke University (1)
United States (30) · United Kingdom (6) · Denmark (2) · Australia (1) · Hungary (1) · Tanzania (1)
Mark Gladwin, MD (3) · Francis Kim, MD (2) · Kara S Hughan, MD (2) · Adaani E Frost, M.D. (1) · Ahmed F Zaky, MD (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)
PMID 21249218, PMID 23550096, PMID 23648219, PMID 23706046, PMID 25512434, PMID 27458234, PMID 27683405, PMID 27812547, PMID 29065098, PMID 30205886, PMID 31599928, PMID 32735111, PMID 32755471, PMID 33421267, PMID 33433575, PMID 33641356, PMID 37565977, PMID 38127015
R01HL128526 (2), P01HL103455 (1), R01HL129722 (1), R01HL130763 (1), R44NS063485 (1), R56AG051637 (1), U10HL110262 (1)