Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV

Condition(s) targeted: Peripheral Arterial Occlusive Disease

Intervention: Alprostadil (Drug); Placebo (Other)

Phase: Phase 4

Status: Recruiting

Sponsored by: UCB, Inc.

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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

1, Karlsbad, Germany; Completed

2, Mannheim, Germany; Withdrawn

502, Aguascalientes, Mexico; Recruiting

501, Queretaro, Mexico; Recruiting

306, Bydgoszcz, Poland; Completed

305, Bydgoszcz, Poland; Withdrawn

321, Konskie, Poland; Completed

320, Krakow, Poland; Completed

314, Lublin, Poland; Completed

315, Lublin, Poland; Completed

316, Poznan, Poland; Completed

317, Poznan, Poland; Completed

301, Szczecin, Poland; Completed

304, Szczecin, Poland; Completed

302, Szczecin, Poland; Withdrawn

303, Szczecin, Poland; Withdrawn

319, Warsaw, Poland; Completed

307, Warszawa, Poland; Completed

308, Warszawa, Poland; Completed

309, Warszawa, Poland; Completed

318, Warszawa, Poland; Completed

312, Wroclaw, Poland; Completed

310, Wroclaw, Poland; Withdrawn

311, Wroclaw, Poland; Withdrawn

313, Wroclaw, Poland; Withdrawn

322, Zamosc, Poland; Completed

246, Barnaul, Russian Federation; Recruiting

205, Chelyabinsk, Russian Federation; Completed

244, Chelyabinsk, Russian Federation; Completed

223, Ekaterinburg, Russian Federation; Recruiting

247, Ekaterinburg, Russian Federation; Recruiting

228, Irkutsk, Russian Federation; Recruiting

242, Kazan, Russian Federation; Recruiting

227, Kemerovo, Russian Federation; Completed

235, Lipetsk, Russian Federation; Withdrawn

233, Moscow, Russian Federation; Withdrawn

202, Moscow, Russian Federation; Completed

203, Moscow, Russian Federation; Completed

219, Moscow, Russian Federation; Completed

220, Moscow, Russian Federation; Completed

230, Moscow, Russian Federation; Completed

209, Moscow, Russian Federation; Recruiting

248, Moscow, Russian Federation; Recruiting

204, Moscow, Russian Federation; Withdrawn

208, Moscow, Russian Federation; Withdrawn

201, Moscow, Russian Federation; Recruiting

226, Nizhny Novgorod, Russian Federation; Withdrawn

231, Novosibirsk, Russian Federation; Recruiting

232, Novosibirsk, Russian Federation; Completed

222, Omsk, Russian Federation; Completed

245, Orenburg, Russian Federation; Withdrawn

217, Petrozavodsk, Russian Federation; Completed

206, Rostov-on-Don, Russian Federation; Completed

225, Rostov-on-Don, Russian Federation; Recruiting

236, Rostov-on-Don, Russian Federation; Recruiting

239, Rostov-on-Don, Russian Federation; Completed

224, Ryazan, Russian Federation; Recruiting

218, Samara, Russian Federation; Recruiting

237, Saratov, Russian Federation; Recruiting

213, St Petersburg, Russian Federation; Completed

210, St Petersburg, Russian Federation; Recruiting

212, St Petersburg, Russian Federation; Recruiting

214, St Petersburg, Russian Federation; Recruiting

215, St Petersburg, Russian Federation; Recruiting

216, St Petersburg, Russian Federation; Recruiting

211, St. Petersburg, Russian Federation; Withdrawn

243, Tula, Russian Federation; Withdrawn

238, Tumen, Russian Federation; Completed

234, Tver, Russian Federation; Recruiting

241, Ufa, Russian Federation; Recruiting

240, Volgograd, Russian Federation; Recruiting

221, Yaroslavl, Russian Federation; Completed

207, Yaroslavl, Russian Federation; Withdrawn

117, Chernigiv, Ukraine; Recruiting

112, Dnipropetrovsk, Ukraine; Recruiting

109, Donetsk, Ukraine; Recruiting

110, Donetsk, Ukraine; Recruiting

114, Ivano-Frankivsk, Ukraine; Recruiting

111, Kharkov, Ukraine; Completed

120, Kherson, Ukraine; Recruiting

101, Kiev, Ukraine; Recruiting

102, Kiev, Ukraine; Recruiting

103, Kiev, Ukraine; Recruiting

104, Kiev, Ukraine; Completed

105, Kiev, Ukraine; Recruiting

106, Lviv, Ukraine; Recruiting

118, Odessa, Ukraine; Recruiting

119, Odessa, Ukraine; Recruiting

115, Poltava, Ukraine; Recruiting

113, Uzhgorod, Ukraine; Recruiting

116, Vinnytsya, Ukraine; Recruiting

107, Zaporozhye, Ukraine; Recruiting

108, Zaporozhye, Ukraine; Recruiting

Starting date: March 2004
Last updated: November 22, 2011