Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV - Full Text View

Purpose

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.

Condition	Intervention	Phase
Peripheral Arterial Occlusive Disease	Drug: Alprostadil Other: Placebo	Phase 4

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

Resource links provided by NLM:

Drug Information available for: Alprostadil

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Rate of complete healing of ulcerations after 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Frequency of amputations after 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of complete healing of all necroses and ulcerations; Intensity of rest pain; Consumption and type of analgesics; minor amputations [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	840
Study Start Date:	March 2004
Estimated Study Completion Date:	August 2013
Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ALPROSTADIL Alprostadil	Drug: Alprostadil 40 µg Alprostadil i.v. b.d. during a Treatment Phase of 4 weeks
Placebo Comparator: PLACEBO Placebo treatment	Other: Placebo Placebo i.v. b.d. during a Treatment Phase of 4 weeks

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596752

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Locations

Czech Republic
404
Plzen, Czech Republic
414
Usti Nad Labem, Czech Republic
Germany
1
Karlsbad, Germany
Mexico
502
Aguascalientes, Mexico
505
Merida, Mexico
501
Queretaro, Mexico
Poland
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
Russian Federation
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
219
Moscow, Russian Federation
220
Moscow, Russian Federation
230
Moscow, Russian Federation
209
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
213
St Petersburg, Russian Federation
210
St Petersburg, Russian Federation
212
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
Ukraine
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

Sponsors and Collaborators

UCB Pharma GmbH

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB, Inc. ( UCB Pharma GmbH )
ClinicalTrials.gov Identifier:	NCT00596752 History of Changes
Other Study ID Numbers:	SP777
Study First Received:	December 21, 2007
Last Updated:	May 15, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Poland: Ministry of Health Czech Republic: State Institute for Drug Control Russia: Ministry of Health of the Russian Federation

Keywords provided by UCB, Inc.:

Alprostadil
Prostavasin

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Peripheral Arterial Disease
Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Peripheral Vascular Diseases
Alprostadil
Platelet Aggregation Inhibitors

Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013

Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV (ESPECIAL)