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Arteriosclerosis ObliteransPhase 2NCT02877173

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

A Phase 2 study testing Alprostadil Liposomes for Injection and Alprostadil Injection in people with Arteriosclerosis Obliterans, run by Guangzhou Yipinhong Pharmaceutical CO.,LTD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Arteriosclerosis Obliterans
What is being tested?
Alprostadil Liposomes for Injection and Alprostadil Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteChina
Study dates
Aug 2016to Dec 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Yongquan Gu contact

010-83198605

China1 site, 1 recruiting

  • Xuanwu Hospital Capital Medical University

    Beijing, 100034

    Yongquan Gu

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Alprostadil Liposomes for Injection in the Treatment of Atherosclerotic Occlusive Disease of the Lower Extremities-A Phase II Multi-center Randomised Controlled Trial

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.

Read the detailed description

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.

Being tested
Alprostadil Liposomes for Injection, Alprostadil Injection
Keywords
Arteriosclerosis Obliterans, Atherosclerotic Occlusive Disease of the Lower Extremities, Intermittent Claudication
Medical subject headings
Arteriosclerosis Obliterans, Intermittent Claudication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alprostadil Liposomes for InjectionDrug

    Also called No other names

    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 InjectionDrug

    Also called No other names

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

Study groups in NCT02877173
Study groupRoleWhat they receive
Alprostadil Liposomes for InjectionExperimentalAlprostadil 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;
Receives: Drug: Alprostadil Liposomes for Injection
Alprostadil InjectionActive comparatorAlprostadil Injection:10ug,once a day,continuous administration for 3 weeks;
Receives: Drug: Alprostadil Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: After 3 weeks of treatment

Secondary outcomes (4)

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

    Unit of maximun distance of claudication :meters

    Measured: After 3 weeks of treatment

  2. 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

    Measured: After 2 weeks of treatment

  3. 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.

    Measured: After 3 weeks of treatment

  4. 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

    Measured: over 3 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionJul 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02877173
Sponsor's protocol ID
YPH-ZZTP-L01
Status last verified
Mar 2017
First submitted
16 Aug 2016
Last updated
10 Mar 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alprostadil Liposomes for Injection and Alprostadil Injection in people with Arteriosclerosis Obliterans, run by Guangzhou Yipinhong Pharmaceutical CO.,LTD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yongquan Gu (010-83198605), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in distance of asymptomatic disease and claudication after 3 weeks of treatment. (time frame: After 3 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02877173.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.

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