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

NCT02877173 | Unknown Phase 2 DMC

• 1 other identifier: YPH-ZZTP-L01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arteriosclerosis Obliterans

Keywords

Arteriosclerosis Obliterans; Atherosclerotic Occlusive Disease of the Lower Extremities; Intermittent Claudication

Outcome Measures

Primary Outcomes (1)

• Change from baseline in distance of asymptomatic disease and claudication after 3 weeks of treatment.

  Unit of distance of asymptomatic disease and claudication:meters

  After 3 weeks of treatment

Secondary Outcomes (4)

• Change from baseline in maximun distance of claudication after 3 weeks of treatment.

  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.

  After 2 weeks of treatment

• The proportion of patients to treatment failure.

  After 3 weeks of treatment

• Incidence of Adverse Events(AEs)

  over 3 weeks of treatment

Study Arms (2)

Alprostadil Liposomes for Injection

EXPERIMENTAL

Alprostadil Liposomes for Injection at low dose:20ug,once a day,continuous administration for 3 weeks; Alprostadil Liposomes for Injection at medium dose:40ug,once a day,continuous administration for 3 weeks; Alprostadil Liposomes for Injection at high dose:60ug,once a day,continuous administration for 3 weeks;

Drug: Alprostadil Liposomes for Injection

Alprostadil Injection

ACTIVE COMPARATOR

Alprostadil Injection:10ug,once a day,continuous administration for 3 weeks;

Drug: Alprostadil Injection

Interventions

Alprostadil Liposomes for Injection DRUG

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.

Also known as: No other names

Alprostadil Liposomes for Injection

Alprostadil Injection DRUG

Alprostadil Injection(the positive control group):10ug/q.d,continuous administration for 3 weeks.

Also known as: No other names

Alprostadil Injection

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Yipinhong Pharmaceutical CO.,LTD: lead

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, 100034, China

RECRUITING

MeSH Terms

Conditions

Arteriosclerosis Obliterans; Intermittent Claudication

Interventions

Injections; Alprostadil

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Monounsaturated; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Yongquan Gu

  Xuanwu Hospital, Beijing

  STUDY CHAIR

• Xiangchen Dai

  Tianjing Medical University General Hospital

  PRINCIPAL INVESTIGATOR

• Bonan Lv

  Hebei General Hospital

  PRINCIPAL INVESTIGATOR

• Jun Zhao

  Shanghai Sixth People Hospital

  PRINCIPAL INVESTIGATOR

• Jichun Zhao

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Dan Liu

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Haofu Wang

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

• Gang Zhao

  First Affiliated Hospital of Heilongjiang Chinese Medicine University

  PRINCIPAL INVESTIGATOR

• Weiguang Guo

  Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Qi Wang

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

• Xiwei Zhang

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongquan Gu

CONTACT

010-83198605

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 24, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 10, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)