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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


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

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