7 completed, 4 terminated, 2 withdrawn. 9 Phase 2, 4 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 9 | Completed 5, Terminated 3, Withdrawn 1 |
| Phase 1 | 4 | Completed 2, Terminated 1, Withdrawn 1 |
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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 |
|---|---|---|---|---|---|---|
| Chlorhexidine Mouthwash and Oral Nitrate in Adults With Pulmonary Hypertension Nitrates, Chlorhexidine Gluconate Mouthwash, Placebo Mouthwash - Pulmonary Hypertension, Heart Failure With Normal Ejection Fraction | Phase 1 | Withdrawn | Gladwin, Mark, MD | 2022-12-01 | 2022-07-07 | |
| Nitrites, Skeletal Muscle Mitochondrial Bioenergetics, and Physical Activity in Old Age Placebos, 20mg sodium nitrite tid - Aging, Sedentary Lifestyle | Phase 2 | Completed | Gladwin, Mark, MD | 64 | 2021-04-23 | 2024-10-10 |
| 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and Metabolic Syndrome 14 Nitrogen (N) Sodium Nitrite, Placebo - Metabolic Syndrome, Hypertension | Phase 2 | Withdrawn | Gladwin, Mark, MD | 2020-10-01 | 2021-04-19 | |
| Oral CXA-10 in Pulmonary Arterial Hypertension CXA-10 - Pulmonary Arterial Hypertension | Phase 2 | Terminated | Gladwin, Mark, MD | 1 | 2019-10-31 | 2022-01-12 |
| Transfusion of Biotin-Labeled Red Blood Cells Biotin-Labeled Red Blood Cells - Healthy Volunteers | Phase 2 | Terminated | Gladwin, Mark, MD | 6 | 2019-09-16 | 2022-04-21 |
| A Study of Oral Nitrate in Adults With Pulmonary Hypertension With Heart Failure and Preserved Ejection Fraction 15N Nitrate, 14N Nitrate - Pulmonary; Hypertension, Heart Failure | Phase 1 | Completed | Gladwin, Mark, MD | 77 | 2017-08-28 | 2022-03-22 |
| 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 |
| 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 |
| Oral Nitrite and Nitrate in Healthy Normal Volunteer Adults 15Nitrogen(15N)-labeled sodium nitrite, 15Nitrogen(15N)-labeled sodium nitrate - Focus of Study of Healthy Adults | Phase 1 | Completed | Gladwin, Mark, MD | 11 | 2012-10-01 | 2018-09-04 |
| 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 |
| Endothelial Injury and Development of Coronary Intimal Thickening After Heart Transplantation Optical Coherence Tomography, Acetylcholine, Brachial Artery Flow Mediated Dilation - Cardiac Allograft Vasculopathy, Antibody Mediated Rejection | Phase 1 | Terminated | Gladwin, Mark, MD | 12 | 2012-09-01 | 2017-09-06 |
| 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 |
Heart Failure (3) · Hypertension (2) · Hypertension, Pulmonary (2) · Metabolic Syndrome (2) · Asthma (1) · Frailty (1) · Obesity (1) · Primary Graft Dysfunction (1) · Pulmonary Arterial Hypertension (1) · Pulmonary Heart Disease (1) · Sedentary Behavior (1)
Sodium Nitrite (6) · Acetylcholine (1) · CXA-10 (1) · Nitrates (1) · Nitrites (1) · Tomography, Optical Coherence (1) · eleostearic acid (1) · sodium nitrate (1)
United States (13)
Kara S Hughan, MD (3) · Mark Gladwin, MD (3) · Alison Morris, MD, MS (1) · Bret Goodpaster, PhD (1) · Catalin Toma, MD (1) · Daniel E Forman, MD (1) · Daniel Forman, MD (1) · Darrell Triulzi, MD (1) · Marc Simon, MD (1) · Mark T Gladwin, MD (1) · Matthew Morrell, MD (1) · Sally E Wenzel, MD (1)
PMID 28739973, PMID 32755471, PMID 41691463
P01HL103455 (3), R01AG058883 (1), R01HL098032 (1), R56AG051637 (1)