Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV
NCT ID: NCT00596752
Last Updated: 2018-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
840 participants
INTERVENTIONAL
2004-03-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Alprostadil
Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Alprostadil
* Active Substance: Prostaglandin E1
* Pharmaceutical Form: solution for infusion
* Concentration: 40 μg b.d.
* Route of Administration: intravenous infusion
Placebo
Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
Placebo
* Active Substance: Lactose
* Pharmaceutical Form: solution for infusion
* Concentration: 40 μg b.d.
* Route of Administration: intravenous infusion
Interventions
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Alprostadil
* Active Substance: Prostaglandin E1
* Pharmaceutical Form: solution for infusion
* Concentration: 40 μg b.d.
* Route of Administration: intravenous infusion
Placebo
* Active Substance: Lactose
* Pharmaceutical Form: solution for infusion
* Concentration: 40 μg b.d.
* Route of Administration: intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
ALL
No
Sponsors
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Aptiv Solutions
INDUSTRY
UCB BIOSCIENCES GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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404
Pilsen, , Czechia
414
Ústí nad Labem, , Czechia
1
Karlsbad, , Germany
502
Aguascalientes, , Mexico
505
Mérida, , Mexico
501
Querétaro, , Mexico
306
Bydgoszcz, , Poland
321
Gmina Końskie, , Poland
320
Krakow, , Poland
314
Lublin, , Poland
315
Lublin, , Poland
316
Poznan, , Poland
317
Poznan, , Poland
301
Szczecin, , Poland
304
Szczecin, , Poland
307
Warsaw, , Poland
308
Warsaw, , Poland
309
Warsaw, , Poland
318
Warsaw, , Poland
319
Warsaw, , Poland
312
Wroclaw, , Poland
322
Zamość, , Poland
246
Barnaul, , Russia
205
Chelyabinsk, , Russia
244
Chelyabinsk, , Russia
228
Irkutsk, , Russia
242
Kazan', , Russia
227
Kemerovo, , Russia
201
Moscow, , Russia
202
Moscow, , Russia
203
Moscow, , Russia
209
Moscow, , Russia
219
Moscow, , Russia
220
Moscow, , Russia
230
Moscow, , Russia
248
Moscow, , Russia
231
Novosibirsk, , Russia
232
Novosibirsk, , Russia
222
Omsk, , Russia
217
Petrozavodsk, , Russia
206
Rostov-on-Don, , Russia
225
Rostov-on-Don, , Russia
236
Rostov-on-Don, , Russia
239
Rostov-on-Don, , Russia
224
Ryazan, , Russia
210
Saint Petersburg, , Russia
212
Saint Petersburg, , Russia
213
Saint Petersburg, , Russia
214
Saint Petersburg, , Russia
215
Saint Petersburg, , Russia
216
Saint Petersburg, , Russia
218
Samara, , Russia
237
Saratov, , Russia
243
Tula, , Russia
234
Tver', , Russia
238
Tyumen, , Russia
241
Ufa, , Russia
240
Volgograd, , Russia
221
Yaroslavl, , Russia
223
Yekaterinburg, , Russia
247
Yekaterinburg, , Russia
112
Dnipropetrovsk, , Ukraine
109
Donetsk, , Ukraine
110
Donetsk, , Ukraine
114
Ivano-Frankivsk, , Ukraine
111
Kharkiv, , Ukraine
101
Kiev, , Ukraine
102
Kiev, , Ukraine
103
Kiev, , Ukraine
104
Kiev, , Ukraine
105
Kiev, , Ukraine
106
Lviv, , Ukraine
118
Odesa, , Ukraine
119
Odesa, , Ukraine
113
Uzhhorod, , Ukraine
116
Vinnytsia, , Ukraine
107
Zaporizhzhya, , Ukraine
108
Zaporizhzhya, , Ukraine
Countries
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References
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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.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2005-001970-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SP0777
Identifier Type: -
Identifier Source: org_study_id
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