drugset / Trial / NCT00725881
Safety, Efficacy, and Pharmacokinetics (PK) Study of Trans Sodium Crocetinate (TSC) in Patients With Intermittent Claudication
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the safety and pharmacokinetics of multiple, once-daily, intravenous doses of trans sodium crocetinate (TSC). The effectiveness of TSC in alleviating the symptoms of intermittent claudication (IC) will also be assessed.
Timeline
- Start
- 2008-08
- Primary completion
- 2010-03
- Completion
- 2010-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trans Sodium Crocetinate | Other / unclassified | 0.25 mg/kg | Intravenous |
| Subject | Trans Sodium Crocetinate | Other / unclassified | 0.5 mg/kg | Intravenous |
| Subject | Trans Sodium Crocetinate | Other / unclassified | 0.75 mg/kg | Intravenous |
| Subject | Trans Sodium Crocetinate | Other / unclassified | 1 mg/kg | Intravenous |
| Subject | Trans Sodium Crocetinate | Other / unclassified | 1.25 mg/kg | Intravenous |
| Subject | Trans Sodium Crocetinate | Other / unclassified | 1.5 mg/kg | Intravenous |
| Subject | Trans Sodium Crocetinate | Other / unclassified | 1.75 mg/kg | Intravenous |
| Subject | Trans Sodium Crocetinate | Other / unclassified | 2 mg/kg | Intravenous |