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Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV

Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Peripheral Arterial Occlusive Disease

Intervention: Alprostadil (Drug); Placebo (Other)

Phase: Phase 4

Status: Completed

Sponsored by: UCB BIOSCIENCES GmbH

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

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.

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)

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

Primary outcome:

Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment

Occurrence of Major Amputations at 24 Weeks After the End of Study Drug Treatment

Secondary outcome:

Complete Healing of Ischemic Necroses and Ulcerations at 24 Weeks After the End of Study Drug Treatment

Intensity of Rest Pain Induced by Ischemic Lesions at 24 Weeks After the End of Study Drug Treatment

Increase/Decrease in Ulcer Area of ≥ 50 % at 24 Weeks After the End of Study Drug Treatment

Consumption and Type of Analgesic Medication During the Course of the Study (up to 196 Days)

Systolic Pressure at Ankle Level at 24 Weeks After the End of Study Drug Treatment

Minor Amputations at 24 Weeks After the End of Study Drug Treatment

Revascularization Procedures at 24 Weeks After the End of Study Drug Treatment

All-cause Mortality During the Course of the Study (up to 196 Days)

Cardiovascular Mortality During the Course of the Study (up to 196 Days)

Cardiovascular Morbidity During the Course of the Study (up to 196 Days)

Eligibility

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

Criteria:

Inclusion Criteria:

- Subject is at least 45 years of age

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

lesions for more than 2 weeks

- Subject has a complete angiography of pelvis, thigh and calf within one month of

inclusion

- Systolic ankle pressure ≤ 70 mmHg in subjects without media sclerosis of the lower

limb artery or systolic big toe pressure ≤ 50 mmHg in diabetics with media sclerosis of the lower limb artery

- Subject is not in the position to be primarily revascularized or refuses surgery

Exclusion Criteria:

- Imminent or foreseeable amputation

- Major amputation on the affected extremity

- History of chronic alcohol or drug abuse

- More than two ischemic ulcerations

- One ulcer ≥ 6 cm^2, both ulcers ≤ 1 cm^2 or at least one ulcer affecting the bone or

tendons

- Acute ischemia and peripheral vascular disorders of inflammatory or immunologic

origin

- Neuropathic or venous ulcers

- Buerger's disease

- Septic gangrene

- Use of vasoactive medication or prostaglandins

- Treatment with prostanoids within 3 months prior to inclusion

- Surgical or interventional measures performed on the affected extremity within 3

months prior to study drug treatment

Locations and Contacts

404, Plzen, Czech Republic

414, Usti Nad Labem, Czech Republic

1, Karlsbad, Germany

502, Aguascalientes, Mexico

505, Merida, Mexico

501, Queretaro, Mexico

306, Bydgoszcz, Poland

321, Konskie, Poland

320, Krakow, Poland

314, Lublin, Poland

315, Lublin, Poland

316, Poznan, Poland

317, Poznan, Poland

301, Szczecin, Poland

304, Szczecin, Poland

319, Warsaw, Poland

307, Warszawa, Poland

308, Warszawa, Poland

309, Warszawa, Poland

318, Warszawa, Poland

312, Wroclaw, Poland

322, Zamosc, Poland

246, Barnaul, Russian Federation

205, Chelyabinsk, Russian Federation

244, Chelyabinsk, Russian Federation

223, Ekaterinburg, Russian Federation

247, Ekaterinburg, Russian Federation

228, Irkutsk, Russian Federation

242, Kazan, Russian Federation

227, Kemerovo, Russian Federation

201, Moscow, Russian Federation

202, Moscow, Russian Federation

203, Moscow, Russian Federation

209, Moscow, Russian Federation

219, Moscow, Russian Federation

220, Moscow, Russian Federation

230, Moscow, Russian Federation

248, Moscow, Russian Federation

231, Novosibirsk, Russian Federation

232, Novosibirsk, Russian Federation

222, Omsk, Russian Federation

217, Petrozavodsk, Russian Federation

206, Rostov-on-Don, Russian Federation

225, Rostov-on-Don, Russian Federation

236, Rostov-on-Don, Russian Federation

239, Rostov-on-Don, Russian Federation

224, Ryazan, Russian Federation

218, Samara, Russian Federation

237, Saratov, Russian Federation

210, St Petersburg, Russian Federation

212, St Petersburg, Russian Federation

213, St Petersburg, Russian Federation

214, St Petersburg, Russian Federation

215, St Petersburg, Russian Federation

216, St Petersburg, Russian Federation

243, Tula, Russian Federation

238, Tumen, Russian Federation

234, Tver, Russian Federation

241, Ufa, Russian Federation

240, Volgograd, Russian Federation

221, Yaroslavl, Russian Federation

112, Dnipropetrovsk, Ukraine

109, Donetsk, Ukraine

110, Donetsk, Ukraine

114, Ivano-Frankivsk, Ukraine

111, Kharkov, Ukraine

101, Kiev, Ukraine

102, Kiev, Ukraine

103, Kiev, Ukraine

104, Kiev, Ukraine

105, Kiev, Ukraine

106, Lviv, Ukraine

118, Odessa, Ukraine

119, Odessa, Ukraine

113, Uzhgorod, Ukraine

116, Vinnytsya, Ukraine

107, Zaporozhye, Ukraine

108, Zaporozhye, Ukraine

Additional Information

FDA Safety Alerts and Recalls

Starting date: March 2004
Last updated: February 26, 2015

Page last updated: August 23, 2015

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