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

NCT01401517 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2020-04-21

Study results available
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Summary

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.

Conditions

  • Peripheral Arterial Disease

Interventions

DRUG

sodium nitrite

0, 40 or 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose.

Sponsors & Collaborators

  • TheraVasc Inc.

    lead INDUSTRY

Principal Investigators

  • Tony Giordano, Ph.D. · TheraVasc Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01401517 on ClinicalTrials.gov