A Safety/Efficacy Study of Alprostadil Liposomes for Injection to Treat Lower Extremity Arteriosclerosis Obliterans

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangzhou Yipinhong Pharmaceutical CO.,LTD
• Treatments: Alprostadil

Criteria

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 months are to be excluded.

• Subjects who have pneumonedema,pulmonary infiltrates,interstitial pneumonia,severe chronic obstructive airway disorders or respiratory insufficiency confirmed by clinical examination.

• Liver:Subjects with abnormal liver function tests defined as aspartate aminotransferase(AST) or alanine aminotransferase(ALT) greater than equal to 1.5 times upper limit of normal,as well as a diagnosis of primary liver disease will be excluded.

• Renal:Subjects with abnormal kidney function tests defined as Creatinine clearance rate(SCr) greater than or equal to upper limit of normal.

• Clinically Uncontrolled Hypertension:Subjects who have clinically significant uncontrolled hypertension(Systolic blood pressure:greater than or equal to 180mmHg;Or diastolic blood pressure:greater than or equal to 110mmHg).

• Ankle systolic pressure is less than or equal to 50mmHg.

• Subjects with affected limbs surgery or endovascular treatment within 3 months prior to Screening.Subjects who received Prostanoids within the past 1 week are to be excluded.

• Subjects who received walking rehabilitation training successfully within the past 6 months.

• Subjects with a diagnosis of other diseases such as lower limb joint disorder,spinal lesions,neuropathy,serious lung and heart conditions which may impact intermittent claudication will be excluded.

• Subjects who have inflammation of the vascular disease including Takayasu's arteritis,edema perivascular.

• Subjects with active peptic ulcerease or bleeding tendency will be excluded.

• Glaucoma:Subjects with a diagnosis of glaucoma or high intraocular pressure will be excluded.

• Subjects who are medically unable to withhold their vasodilator including naftidrofuryl,pentoxy,buflomedil or cilostazol will be excluded.

• Subjects who received any powerful analgesic within 1 month perior to Screening.

• Subjects with a history of psychiatric disease or Alzheimer's Disease.

• Cancer:Subjects with a diagnosis of cancer will be excluded.

• Drug Allergy:Subjects who have a history of any componet of Alprostadil Injection.

• Previous Participation:Subjects who were previously enrolled in any clinical trial within 1 month period to Screening.

• Pregnancy:Women who are pregnant or lactating or women of childbearing potential who are not using an acceptable method of contraception.

• Subjects,who in the opinion of the Investigator,will not be fit for this study.