Dose-finding, Safety and Efficacy Study of NV1FGF in Patients With Intermittent Claudication
Completed · Phase 2 · Has a placebo group
Conditions studied: Peripheral Arterial Occlusive Disease
In brief
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.
Key facts
- Study ID
- NCT01157871
- Run by
- Sanofi
- People needed
- 36
- Starts
- 2004-06-01
- Expected to finish
- 2005-08-01
- Last updated by the study team
- 2010-07-07
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age>40 years
- History of typical intermittent claudication lasting for at least 3 months, showing no improvement and consistent with treadmill test findings
- Objective evidence of Peripheral Arterial Occlusive Disease. After 10 minutes of rest, either by Ankle brachial index measure (ABI) <0.8 or Systolic ankle pressure (AP) < 50 mmHg or Systolic toe pressure <50 mmHg
- Patent femoral inflow above the level of injections recently (<2 weeks) documented either with Doppler ultrasonography or Magnetic Resonance Angiography or Angiography
You may not qualify if…
- Evidence of other causes for leg pain other than intermittent claudication.
- Illnesses limiting subject exercise capacity (angina pectoris, heart failure, respiratory disease, orthopaedic disease, neurological disorders…)
- Pain at rest
- Buerger's disease
- Positive serology for HIV 1 or 2, positive serology hepatitis B or C.
- Subjects with serum creatinine > 2 mg/dl (176 µmol/l) and subjects on dialysis.
- Active proliferative retinopathy defined by the presence of new vessel formation and scarring.
- Subjects who had a stroke or neurologic deficit presumed to be due to stroke within 3 months prior to the first administration of study treatment
- Previous treatment with any angiogenic growth factor
- Pregnant or breast feeding women or who disagree to practice a medically accepted method of birth control. Men and women who do not agree to use condoms as the only accepted protection barrier, for the entire study period
- Serious concomitant medical conditions not adequately controlled.
- Current alcohol or drug abuse
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Where it is running
- Study site — Minneapolis, Minnesota, United States
- Study site — Brussels, Belgium
- Study site — Münster, Germany
- Study site — Bern, Switzerland
Full record on ClinicalTrials.gov
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