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


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




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 Status: Completed


Condition Intervention Phase
Peripheral Arterial Disease Drug: sodium nitrite Phase 2

Verified by TheraVasc Inc. February, 2013

Sponsored by: TheraVasc Inc.
Information provided by: TheraVasc Inc. identifier: NCT01401517

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

The Cleveland Clinic
Cleveland, Ohio 44106
United States

Tony Giordano, Ph.D.., Study Director

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