Arteriosclerosis Obliterans Clinical Trial
Official title:
Efficacy and Safety of Alprostadil Liposomes for Injection in the Treatment of Atherosclerotic Occlusive Disease of the Lower Extremities—A Phase II Multi-center Randomised Controlled Trial
A phase II,randomized,double-blind,multi-doses,positive drug parallel controlled,multi-center clinical trial to evaluate initially the efficacy and safety of alprostadil liposomes for injection in the treatment of atherosclerotic occlusive disease of the lower extremities.
This is a phase 2 dose-finding study evaluating initially the efficacy and safety of
alprostadil liposomes for injection in the treatment of atherosclerotic occlusive disease of
the lower extremities at different dose strengths.The total duration of subject
participation will be approximately 5 weeks,consisting of a 2-week run-in period,3-week
treatment and safety follow-up period.
Subjects will sign the informed consent form(ICF) at a screening visit and will be assigned
a subject identifier.Subjects meeting all inclusion/exclusion criteria and who have
successfully completed all protocol procedures at screening will enter the 2-week
run-in.Following the 2-week run-in period,eligible subjects will be randomized(1:1:1:1) to
one of the following double-blind treatment groups:
Group A : Alprostadil Liposomes for Injection at low dose:20ug,once a day(QD); Group B :
Alprostadil Liposomes for Injection at medium dose:40ug,QD Group C : Alprostadil Liposomes
for Injection at high dose:60ug,QD Group D(Positive Control Group) : Alprostadil
Injection:10ug,QD All treatments will be delivered by intravenously guttae.A subject will be
consider to have completed the study when they have completed all phase of the study
including run-in,randomization,the randomized treatment and efficacy and safety follow-up
phase.
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