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Completed Phase 2 Interventional Results available

Phase IIa: Safety, PK, & Tolerability of Sodium Nitrite in Patients With Peripheral Arterial Disease-SONIC

ClinicalTrials.gov ID: NCT01401517

Public ClinicalTrials.gov record NCT01401517. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 10:25 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01401517
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
TheraVasc Inc.
Industry
Enrollment
55 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
35 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2011 (Type not available)
Primary completion
Jan 2013 (Actual)
Completion
Jan 2013 (Actual)
Last update posted
Apr 21, 2020

2011 – 2013

United States locations

U.S. sites
10
U.S. states
7
U.S. cities
9
Facility City State ZIP Site status
University of Colorado Denver Health Sciences Center Aurora Colorado 80045 —
Emory University Atlanta Georgia 30322 —
University of Iowa Iowa City Iowa 52242 —
University of Cincinnati Cincinnati Ohio 45267 —
The Cleveland Clinic Cleveland Ohio 44106 —
University Hospitals Cleveland Ohio 44106 —
The Ohio State University Columbus Ohio 43210 —
University of Pennsylvania Philadelphia Pennsylvania 19104 —
Vanderbilt Heart and Vascular Institute Nashville Tennessee 37232 —
Medical College of Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01401517, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 21, 2020 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01401517 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →