Alprostadil in PAOD Stage IV
Information source: UCB
Information obtained from ClinicalTrials.gov on November 03, 2008 Link to the current ClinicalTrials.gov record.
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
Summary
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
Clinical Details
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 weeksfrequency 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
Eligibility
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
Locations and Contacts
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
Additional Information
Starting date: March 2004
Ending date: November 2008
Last updated: September 11, 2008
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