A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-Selection Study of Ad2/Hypoxia Inducible Factor HIF-1alfa/VP16 in Patients with Intermittent Claudication

Update Il y a 4 ans
Reference: EUCTR2004-002508-13

Woman and Man

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Extract

To examine the safety of an experimental gene transfer agent, Ad2/HIF-1α/VP16, and its ability to stimulate the growth of new blood vessels from existing blood vessels (a process called angiogenesis) in an attempt to improve the flow of blood in the legs of patients with peripheral arterial disease (PAD). This is done by assessing: • the safety and tolerability of 3 doses of Ad2/HIF-1α/VP16 compared to Placebo-control in the treatment of severe intermittent claudication (IC) • the efficacy of 3 doses of Ad2/HIF-1α/VP16 compared to Placebo-control in the treatment of severe IC


Inclusion criteria

  • Peripheral Arterial Disease (PAD): Intermittent Claudication (IC)