CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 840 enrolled
Drug / intervention
Alprostadil +1 moredrug
Likely dose
Alprostadil 40 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00596752
NCT00596752Phase 4Completed
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Multinational, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Assess the Efficacy and Safety of Prostaglandin E1 in Subjects With Critical Limb Ischemia (Fontaine Stage IV)

UCB BIOSCIENCES GmbH·interventional·Posted Jan 17, 2008·Updated Apr 4, 2018

In Brief

A Phase 4 clinical trial evaluating Alprostadil and Placebo for Peripheral Arterial Occlusive Disease. Completed, enrolled 840 participants across 78 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Arterial Occlusive Disease
CountriesCzechia, Germany, Mexico, Poland, Russia, Ukraine
CollaboratorsAptiv Solutions

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 17, 2008
Enrollment StartMar 1, 2004
Primary CompletionMay 1, 2013
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 18.5 years ago

Interventions

Alprostadildrug

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

Placeboother

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