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NCT01401517 · ClinicalTrials.gov registry record · Phase 2
Phase IIa: Safety, PK, & Tolerability of Sodium Nitrite in Patients With Peripheral Arterial Disease-SONIC
A Phase 2 study, sponsored by TheraVasc.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT01401517: Completed Phase 2 study, sponsored by TheraVasc.
NCT01401517 is a Phase 2 study that has completed, run by TheraVasc. The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01401517, a Phase 2 study, has completed, sponsored by TheraVasc.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG sodium nitrite
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
What the finished NCT01401517 record still lists
NCT01401517 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 1 intervention - of which sodium nitrite is the first listed.
NCT01401517 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01401517 about?
NCT01401517 is a clinical study titled "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. 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 t...
What is the current status of trial NCT01401517?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2011-07. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01401517?
The interventions under investigation include: sodium nitrite (DRUG).
Who is sponsoring clinical trial NCT01401517?
This trial is sponsored by TheraVasc, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01401517's enrollment target sits among peer trials
55 1153rd of 2000 higher than 841 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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