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

NCT01157871 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2010-07-07

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Occlusive Disease

Interventions

DRUG

XRP0038 (NV1FGF)

Pharmaceutical form:solution Route of administration: intramuscular

DRUG

placebo

Pharmaceutical form:solution Route of administration: intramuscular

Sponsors & Collaborators

Principal Investigators

  • International Clinical Development Study Director · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2005-08-31
Completion
2005-08-31

Countries

  • United States
  • Belgium
  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01157871 on ClinicalTrials.gov