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Safety and Tolerability of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease

NCT01157156 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2010-07-05

No results posted yet for this study

Summary

The primary objective is to evaluate safety and tolerability of single and repeated administrations of escalating doses of NV1FGF administered intramuscularly in patients with severe Peripheral Artery Occlusive Disease (PAOD), (Rutherford's Grade II, category 4 or Grade III, category 5 and 6).

Secondary objectives are:

* To determine the biological activity of NV1FGF on collateral artery development.
* To evaluate the activity of NV1FGF on hemodynamic and clinical parameters.

Conditions

  • Peripheral Arterial Occlusive Disease

Interventions

DRUG

XRP0038 (NV1FGF)

Pharmaceutical form:solution Route of administration: intramuscular

Sponsors & Collaborators

Principal Investigators

  • International Clinical Development Study Director · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-06-30
Primary Completion
2001-09-30
Completion
2001-09-30

Countries

  • United States
  • Finland

Study Locations

More Related Trials

Entities

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 NCT01157156 on ClinicalTrials.gov