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Dose-finding, Safety and Efficacy Study of NV1FGF in Patients With Intermittent Claudication — TALISMAN 211  

Peripheral Arterial Occlusive Disease Clinical Trial

Official title:
Double-blind, Randomized, Placebo-controlled, Parallel Group and Dose-finding, Multicentric, Safety and Efficacy Study With Intramuscular Injections of NV1FGF in Subjects With Intermittent Claudication

Clinical Trial Summary

The primary objective is to assess safety and efficacy of two different doses of NV1FGF as compared to placebo.

The secondary objective is to assess the pharmacokinetics of NV1FGF and FGF-1 protein.

Clinical Trial Description

Screening of 1 to 4 weeks before study drug administration; 6 weeks of treatment, followed by 20 weeks of follow-up. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01157871
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 2
Start date June 2004
Completion date August 2005
View Details
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