NCT01401517

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2011

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 1, 2014

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

1.5 years

First QC Date

June 28, 2011

Results QC Date

May 29, 2014

Last Update Submit

April 20, 2020

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

  • Reporting of Adverse Events During 11 Week Treatment Period.

    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 changes from baseline.

    11 weeks

Secondary Outcomes (3)

  • Assessment of Changes in Brachial Artery Flow-Mediated Dilation (FMD)at 10 Weeks From Baseline

    10 weeks

  • Assessment of Changes in Walking Distance.

    10 weeks

  • Assessment of Improvement of Quality of Life Using the WIQ (Walking Impairment Questionnaire) and SF-36 Questionnaire.

    10 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Microcrystalline cellulose NF at 60 mg/capsule, BID

Drug: sodium nitrite

40 mg Sodium Nitrite

EXPERIMENTAL

40 mg dose, BID

Drug: sodium nitrite

80 mg Sodium Nitrite

EXPERIMENTAL

80 mg dose, BID

Drug: sodium nitrite

Interventions

sodium nitriteDRUG

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

Also known as: TV1001
40 mg Sodium Nitrite80 mg Sodium NitritePlacebo

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject is between and including 35 and 85 years of age.
  • Subjects must be either male or females post-menopausal, sterilized or using suitable birth control. Suitable birth control must be total abstinence, male partner sterilization or double barrier method paired with using oral contraception, injectable progestogen, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, or intrauterine device (IUD).
  • History of Peripheral Arterial Disease (PAD) confirmed by medical chart or an ankle brachial pressure index at rest ≤0.90.
  • If receiving medical standard treatment for cardiac risk factors, subject must have been on a stable treatment for at least 1 month prior to Screening. Treatments must have not changed significantly in the last month and are not expected to change over the duration of the study.
  • If subjects experience claudication symptoms, subjects must have stable lower extremity symptoms for at least 1 month prior to Screening.
  • Ability to provide written informed consent and willingness as documented by a signed informed consent form.

You may not qualify if:

  • Non-atherosclerotic PAD.
  • Lower extremity surgical or percutaneous revascularization, evidence of graft failure or other peripheral vascular surgical procedure within last 6 months prior to Screening.
  • Anticipated lower extremity revascularization within the treatment period.
  • Myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack within 3 months prior to Screening.
  • Poorly controlled diabetes (HgA1c \> 10.0).
  • Poorly controlled hypertension (systolic blood pressure (SBP) ≥ 160 mmHg or diastolic blood pressure (DBP) ≥ 100 mmHg) despite therapy.
  • Systolic blood pressure ≤100 mmHg on current medical regimen.
  • Hypersensitivity to sodium nitrite or related compounds.
  • Renal insufficiency documented as eGFR \< 30 mL/minute/1.73 m2.
  • Pregnant or nursing women.
  • Life expectancy \< 6 months.
  • A chronic illness that may increase the risks associated with this study in the opinion of the investigator.
  • Active malignancy requiring active anti-neoplastic therapy that will, in the opinion of the investigator, interfere with study treatment or participation.
  • Active infection.
  • NYHA CHF Class III or IV.
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of Colorado Denver Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44106, United States

Location

University Hospitals

Cleveland, Ohio, 44106, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt Heart and Vascular Institute

Nashville, Tennessee, 37232, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

  • Mohler ER 3rd, Hiatt WR, Gornik HL, Kevil CG, Quyyumi A, Haynes WG, Annex BH. Sodium nitrite in patients with peripheral artery disease and diabetes mellitus: safety, walking distance and endothelial function. Vasc Med. 2014 Feb;19(1):9-17. doi: 10.1177/1358863X13515043. Epub 2013 Dec 20.

    PMID: 24363302BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Sodium Nitrite

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

NitritesNitrous AcidNitrogen CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Tony Giordano
Organization
TheraVasc Inc.
tgiordano@theravasc.com
318-349-3851

Study Officials

  • Tony Giordano, Ph.D.

    TheraVasc Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2011

First Posted

July 25, 2011

Study Start

July 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

April 21, 2020

Results First Posted

July 1, 2014

Record last verified: 2020-04

Locations

US(10)