Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV

Phase 4 Completed 840 enrolled UCB BIOSCIENCES, Inc. Aptiv Solutions · collab

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2004-03
Primary completion: 2013-05
Completion: 2013-07

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Alprostadil vs Placebo; p = 0.3463; Cochran-Mantel-Haenszel NCT00596752 ↗

registry analysis (superiority or other test); Alprostadil vs Placebo; p = 0.1154; Cochran-Mantel-Haenszel NCT00596752 ↗

paper In this study, superiority of alprostadil over placebo could not be shown. PMID 28189475 ↗

Publications

Results Lawall H, Pokrovsky A, Checinski P, Ratushnyuk A, Hamm G, Randerath O, Grieger F, Bentz JWG. Efficacy and Safety of Alprostadil in Patients with Peripheral Arterial Occlusive Disease Fontaine Stage IV: Results of a Placebo Controlled Randomised Multicentre Trial (ESPECIAL). Eur J Vasc Endovasc Surg. 2017 Apr;53(4):559-566. doi: 10.1016/j.ejvs.2016.12.035. Epub 2017 Feb 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alprostadil	Unknown	40 ug	Intravenous