Alprostadil in PAOD Stage IV

Condition(s) targeted: Peripheral Arterial Occlusive Disease

Intervention: Alprostadil (Drug); Placebo (Other)

Phase: Phase 4

Status: Recruiting

Sponsored by: UCB

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)

Overall contact:
UCB Clinical Trial Call Center, Phone: +1 877 822 9493

The study is to confirmedly show a superior effect of Alprostadil compared to placebo on the rate of complete healing of ischemic necroses and ulcerations

Official title: 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) P

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Rate of complete healing of ulcerations after 12 weeks

frequency of amputations after 24 weeks

Secondary outcome: Rate of complete healing of all necroses and ulcerations; Intensity of rest pain; Consumption and type of analgesics; minor amputations

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects with macro-angiopathy, proven PAOD Stage IV with 2 ischaemic skin lesions

- No primary revascularization recommended

Exclusion Criteria:

- Imminent or foreseeable amputation

- History of chronic alcohol or drug abuse

- More than two ischemic ulcerations

- Acute ischemia and peripheral vascular disorders of inflammatory or immunologic

origin

- Neuropathic or venous ulcers

- Buerger's disease

UCB Clinical Trial Call Center, Phone: +1 877 822 9493

Karlsbad, Germany; Recruiting

Szczecin, Poland; Recruiting

Bydgoszcz, Poland; Recruiting

Warszawa, Poland; Recruiting

Wroclaw, Poland; Recruiting

Lublin, Poland; Recruiting

Poznan, Poland; Recruiting

Krakow, Poland; Recruiting

Konskie, Poland; Recruiting

Zamosc, Poland; Recruiting

Moscow, Russian Federation; Recruiting

St Petersburg, Russian Federation; Recruiting

Rostov-on-Don, Russian Federation; Recruiting

Chelyabinsk, Russian Federation; Recruiting

Jaroslavl, Russian Federation; Recruiting

Omsk, Russian Federation; Recruiting

Ekaterinburg, Russian Federation; Recruiting

Rjazan, Russian Federation; Recruiting

Kemerovo, Russian Federation; Recruiting

Irkutsk, Russian Federation; Recruiting

Tver, Russian Federation; Recruiting

Novosibirsk, Russian Federation; Recruiting

Lipetsk, Russian Federation; Completed

Saratov, Russian Federation; Recruiting

Tumen', Russian Federation; Recruiting

Volgograd, Russian Federation; Recruiting

Petrozavodsk, Russian Federation; Recruiting

Samara, Russian Federation; Recruiting

Kiev, Ukraine; Recruiting

Lviv, Ukraine; Recruiting

Zaporozhye, Ukraine; Recruiting

Donetsk, Ukraine; Recruiting

Dnepropetrovsk, Ukraine; Recruiting

Starting date: March 2004
Ending date: November 2008
Last updated: September 11, 2008