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

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

Interventions

DRUG

Alprostadil Liposomes for Injection

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.

DRUG

Alprostadil Injection

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

Sponsors & Collaborators

• Guangzhou Yipinhong Pharmaceutical CO.,LTD

  lead INDUSTRY

Principal Investigators

• Yongquan Gu · Xuanwu Hospital, Beijing

• Xiangchen Dai · Tianjing Medical University General Hospital

• Bonan Lv · Hebei General Hospital

• Jun Zhao · Shanghai Sixth People Hospital

• Jichun Zhao · West China Hospital

• Dan Liu · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

• Haofu Wang · The Affiliated Hospital of Qingdao University

• Gang Zhao · First Affiliated Hospital of Heilongjiang Chinese Medicine University

• Weiguang Guo · Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

• Qi Wang · The First Hospital of Jilin University

• Xiwei Zhang · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-31

Primary Completion

2017-07-31

Completion

2017-12-31

Countries

• China

Study Locations