NCT01157871

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Peripheral Arterial Occlusive Disease

Interventions

Type	Name	Description
DRUG	XRP0038 (NV1FGF)	Pharmaceutical form:solution Route of administration: intramuscular
DRUG	placebo	Pharmaceutical form:solution Route of administration: intramuscular

Timeline

• Start date: 2004-06-01
• Primary completion: 2005-08-01
• Completion: 2005-08-01
• First posted: 2010-07-07
• Last updated: 2010-07-07

Locations

4 sites across 4 countries: United States, Belgium, Germany, Switzerland