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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
3 doses of Alprostadil Liposomes for Injection are 20ug/q.d,40ug/q.d,60ug/q.d.All groups will be continuous administration for 3 weeks.
Alprostadil Injection(the positive control group):10ug/q.d,continuous administration for 3 weeks.
Xuanwu Hospital Capital Medical University
Beijing, China
RECRUITINGChange from baseline in distance of asymptomatic disease and claudication after 3 weeks of treatment.
Unit of distance of asymptomatic disease and claudication:meters
Time frame: After 3 weeks of treatment
Change from baseline in maximun distance of claudication after 3 weeks of treatment.
Unit of maximun distance of claudication :meters
Time frame: After 3 weeks of treatment
Change from baseline in distance of asymptomatic disease and claudication and in maximum distance of claudication after 2 weeks of treatment.
Unit of distance of asymptomatic disease and claudication:meters
Time frame: After 2 weeks of treatment
The proportion of patients to treatment failure.
The treatment failure is defined as arteriosclerosis obliterans(ASO) exacerbation that has necessary to change chemotherapy or have interventional operation.
Time frame: After 3 weeks of treatment
Incidence of Adverse Events(AEs)
The safety endpoints for this study include: 1. AEs 2. Vital Sign Measurements 3. Physical examination 4. Clinical Laboratory Evaluations
Time frame: over 3 weeks of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.