Safety, Efficacy, and Pharmacokinetics (PK) Study of Trans Sodium Crocetinate (TSC) in Patients With Intermittent Claudication

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

August 31, 2008

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2010

Conditions
Intermittent Claudication
Interventions
DRUG

Trans sodium crocetinate (TSC)

Once-daily bolus intravenous injections in a superficial vein of the arm via syringe over a period of up to 2 minutes. Each patient will receive up to 5 doses given on 5 consecutive days

DRUG

0.9% normal saline

A total volume of 5.0 mL normal saline will be dosed in a superficial vein of the arm via syringe over a period of up to 2 minutes.

Trial Locations (7)

19104

Hospital of the University of Pennsylvania, Philadelphia

32561

Andrews Research and Education, Pensacola

35211

Cardiology, P.C., Birmingham

73104

University of Oklahoma Health Sciences Center, Oklahoma City

78229

Clinical Trials of Texas, Inc., San Antonio

95405

Radiant Research, Inc., Santa Rosa

94305-5406

Stanford University School of Medicine, Division of Cardiovascular Medicine, Stanford

Sponsors
All Listed Sponsors
lead

Diffusion Pharmaceuticals Inc

INDUSTRY