A Safety/Efficacy Study of Alprostadil Liposomes for Injection to Treat Lower Extremity Arteriosc… (NCT02877173) | Clinical Trial Compass
UnknownPhase 2
A Safety/Efficacy Study of Alprostadil Liposomes for Injection to Treat Lower Extremity Arteriosclerosis Obliterans
China160 participantsStarted 2016-08
Plain-language summary
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.
Who can participate
Age range40 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* An established clinical history of Atherosclerotic Occlusive Disease of the Lower Extremities in accordance with the definition by Chinese Medical Association(2015).
* Age\>40
* Atherosclerotic Occlusive Disease of the Lower Extremities diagnosis
* Arterial ischemia of the lower extremities pulsation has been weakened or disappeared.
* Ankle brachial index(ABI) less than or equal to 0.9
* Diagnosis of artery stenosis or occlusion with imaging tests,including Doppler ultrasonography,CT angiogram(CTA),magnetic resonance angiography (MRA) or digital subtraction angiography(DSA) within 1 month prior to Screening.
* Fontaine stage classification:Stage II
* Distance of asymptomatic disease and claudication between 50m to 800m(The treadmill setting:pace at 3 km/h,incline at 12%).Subjects have intermittent claudication twice within 1 week prior to enrollment visit(Baseline is defined as the first measurement.Change from baseline in P-values less than or equal to 25%).
* Age:80 years old or younger.
* Intermittent claudication has been in stable condition in the last 6 months.And there was no history of exacerbations within 3 months prior to enrollment visit.
* Informed Consent:A signed and dated written informed consent prior to study participation.
Exclusion Criteria:
* Subjects who have cardiac disease including caradiac failure,arrhythmias,coronary disease,mitral or aortic stenosis.Subjects with a recent history of myocardial infarction within the past 6 m…
What they're measuring
1
Change from baseline in distance of asymptomatic disease and claudication after 3 weeks of treatment.