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Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV

NCT00596752 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 840

Last updated 2018-04-04

Study results available
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Summary

The study is to confirmatorily show a superior effect of Alprostadil compared to placebo on the rate of complete healing of ischemic necroses and ulcerations as well as on the frequency and height of major amputations in patients suffering from PAOD stage IV.

Conditions

  • Peripheral Arterial Occlusive Disease

Interventions

DRUG

Alprostadil

* Active Substance: Prostaglandin E1 * Pharmaceutical Form: solution for infusion * Concentration: 40 μg b.d. * Route of Administration: intravenous infusion

OTHER

Placebo

* Active Substance: Lactose * Pharmaceutical Form: solution for infusion * Concentration: 40 μg b.d. * Route of Administration: intravenous infusion

Sponsors & Collaborators

  • Aptiv Solutions

    collaborator INDUSTRY

  • UCB BIOSCIENCES GmbH

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2013-05-31
Completion
2013-07-31

Countries

  • Czechia
  • Germany
  • Mexico
  • Poland
  • Russia
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00596752 on ClinicalTrials.gov