Clinical trials: Nitrite
Peripheral Arterial Disease
Phase IIa: Safety, PK, & Tolerability of Sodium Nitrite in Patients With Peripheral Arterial Disease-SONIC
Sodium nitrite has been demonstrated to promote new blood vessel growth, speed up wound healing and prevent tissue necrosis in animals.
- Trial name
- NCT01401517
- Testing
- sodium nitrite
- Where
- 10 sites in United States
- Volunteers
- 55 people
- Sponsor
- TheraVasc Inc.
Asymptomatic Bacteriuria, Asymptomatic Pyuria
Urinalysis Results in Healthy Individuals
This is a prospective, observational study assessing the results of urine dipsticks on adult volunteers with no acute symptoms. We seek to determine the frequency of leukocytes or nitrites in this group of individuals.
- Trial name
- NCT04055675
- Testing
- Urine dipstick test
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Kendall Healthcare Group, Ltd.
Pulmonary Arterial Hypertension
A Phase 2 Study to Determine the Safety and Efficacy of AIR001 in Subjects With Pulmonary Arterial Hypertension (PAH)
The purpose of this study is to evaluate the safety and effectiveness of an investigational/experimental drug called AIR001. To test the effectiveness, the study will evaluate how AIR001 affects the blood vessels in the lungs and…
- Trial name
- NCT01725256
- Testing
- AIR001 (sodium nitrite inhalation solution)
- Where
- 25 sites in United States, Australia and 1 more
- Volunteers
- 29 people
- Sponsor
- Aires Pharmaceuticals, Inc.
Pulmonary Hypertension, Pulmonary Arterial Hypertension
Safety, Tolerability, and PK Parameters of Sodium Nitrite Inhalation Solution in Healthy Subjects
This is a four-part study of the safety, tolerability, and PK profile of sodium nitrite inhalation solution (AIR001) of ascending multiple doses (Part A) and of escalating doses with steady-state sildenafil (Part B) to healthy…
- Trial name
- NCT01409122
- Testing
- 15 mg sodium nitrite inhalation solution, 90 mg sodium nitrite inhalation solution, 45 mg sodium nitrite inhalation solution
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Aires Pharmaceuticals, Inc.
Subarachnoid Hemorrhage
Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm
The purpose of the study is to examine the safety of a 14 day infusion of sodium nitrite, and to study the pharmacokinetics of nitrite, during a 14 day infusion in patients with ruptured cerebral aneurysms.
- Trial name
- NCT00873015
- Testing
- Sodium nitrite, Saline
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Hope Pharmaceuticals
COVID-19, Acute Respiratory Distress Syndrome
Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite
This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Nitrite Injection for treatment of patients infected with COVID-19 who develop lung injury…
- Conditions
- COVID-19, Acute Respiratory Distress Syndrome, Acute Respiratory Failure
- Trial name
- NCT04401527
- Testing
- Sodium Nitrite, Normal Saline
- Where
- 2 sites in United States
- Sponsor
- Hope Pharmaceuticals
Diabetes
A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain
In this study, subjects with diabetic neuropathic pain (DNP) will be treated for 12 weeks with either placebo, 40 or 80 mg sustained release sodium nitrite (TV1001sr) twice daily.
- Trial name
- NCT02412852
- Testing
- Sodium nitrite
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- TheraVasc Inc.
Cyanide Poisoning
Study of SIAN Nasal Spray in Healthy Adults
This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of Stabilized Isoamyl Nitrite (SIAN) nasal spray in healthy subjects.
- Trial name
- NCT05194358
- Testing
- Stabilized Isoamyl Nitrite (SIAN)
- Where
- 2 sites in United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Pulmonary Arterial Hypertension
Long-term Study of AIR001 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension Who Completed AIR001-CS05
The AIR001-CS05 study evaluated the safety and efficacy (effectiveness) of AIR001 over 16 weeks in subjects who have PAH. The purpose of the AIR001-CS06 study is to evaluate the intermediate / long-term safety of AIR001 in…
- Trial name
- NCT01725269
- Testing
- AIR001
- Where
- 25 sites in United States, Australia and 1 more
- Volunteers
- 17 people
- Sponsor
- Aires Pharmaceuticals, Inc.
Pulmonary Arterial Hypertension
Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers
This study is designed to investigate the safety and tolerability of AIR001 Inhalation Solution when administered under conditions of hypoxia and to identify dose levels of drug resulting in a reduction in pulmonary arterial…
- Trial name
- AIR001-CS02 (NCT00814645)
- Testing
- Sodium Nitrite Inhalation Solution
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Aires Pharmaceuticals, Inc.
Subarachnoid Hemorrhage
Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage
The hypothesis is that intravenous infusion of sodium nitrite is safe and effective for the reversal of cerebral vasospasm after subarachnoid hemorrhage in patients with a cerebral aneurysm.
- Trial name
- NCT02176837
- Testing
- Sodium Nitrite
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Hope Pharmaceuticals
Oral Dysbiosis
Effects of a Composition on the Oral Microbiome, pH, Nitrite/Nitrate Ratio, Elastases and Inflammation in Oral Dysbiosis
Dysbiosis is a condition in which the normal function of an ecological net is altered. In dysbiosis a state of inflammation, a loss of hydration, a change in pH, a loss of the barrier function are all allies of key pathogens that…
- Trial name
- NCT05463484
- Testing
- Test composition Saliactive® (olive product, betaine and xylitol), Control
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Mucosa Innovations, S.L.