NCT00596752

Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 840 (actual)
• Sponsor: UCB BIOSCIENCES GmbH · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2004-03-01
• Primary completion: 2013-05-01
• Completion: 2013-07-01
• First posted: 2008-01-17
• Last updated: 2018-04-04
• Results posted: 2014-08-12

Locations

78 sites across 6 countries: Czechia, Germany, Mexico, Poland, Russia, Ukraine