NCT01401517

A Randomized, Double-blinded, Placebo-controlled, Phase IIa Dose-ranging Study to Assess the Safety, Pharmacokinetics, and Tolerability of Multiple Doses of Sodium Nitrite in Patients With Peripheral Arterial Disease (PAD) - SONIC

Completed Phase 2 Results posted Last updated 20 April 2020

What this trial tests

Phase 2 trial testing sodium nitrite in Peripheral Arterial Disease in 55 participants. Completed in 1 January 2013.

Timeline

1 July 2011

Primary endpoint
1 January 2013

1 January 2013

Quick facts

Lead sponsor	TheraVasc Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	55
Start date	1 July 2011
Primary completion	1 January 2013
Estimated completion	1 January 2013
Sites	10 locations across United States

Drugs / interventions tested

• sodium nitrite (SODIUM NITRITE) — full drug profile →

Conditions studied

• Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →

Sponsor

TheraVasc Inc.

Who can join

Adults 35 to 85, any sex, with Peripheral Arterial Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Reporting of Adverse Events During 11 Week Treatment Period.
  Time frame: 11 weeks
  The primary objective of this clinical study is to evaluate the safety and tolerability of multiple doses of twice daily 40mg and 80mg sodium nitrite compared with placebo over a 10 week treatment period. Subjects will be asked to report any adverse events during the trial period, and blood pressure, methemoglobin levels and other blood chemistries will be assessed during the trial period for chan

Sponsor's own description

Sodium nitrite has been demonstrated to promote new blood vessel growth, speed up wound healing and prevent tissue necrosis in animals. Since patients with PAD experience many of these problems, this study will seek to determine whether this drug, when given orally, could provide the same benefits to patients with PAD.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mitochondria as a drug target in ischemic heart disease and cardiomyopathy.
   Walters AM, Porter GA, Brookes PS. · · 2012 · cited 213× · PMID 23065345 · DOI 10.1161/circresaha.112.265660
2. Inorganic nitrite supplementation for healthy arterial aging.
   Sindler AL, Devan AE, Fleenor BS, Seals DR. · · 2014 · cited 51× · PMID 24408999 · DOI 10.1152/japplphysiol.01100.2013
3. Clinical Applications for Gasotransmitters in the Cardiovascular System: Are We There Yet?
   Arrigo E, Comità S, Pagliaro P, Penna C, et al · · 2023 · cited 9× · PMID 37569855 · DOI 10.3390/ijms241512480
4. Gasotransmitters in Modern Medicine: Promises and Challenges in the Use of Porous Crystalline Carriers.
   Pinto RV, Pinto ML, Serre C. · · 2025 · cited 7× · PMID 40059496 · DOI 10.1002/adhm.202404553