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Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV (ESPECIAL)
This study is currently recruiting participants.
Verified by UCB, May 2009
First Received: December 21, 2007   Last Updated: May 11, 2009   History of Changes
Sponsored by: UCB
Information provided by: UCB
ClinicalTrials.gov Identifier: NCT00596752
  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 IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Alprostadil
U.S. FDA Resources

Further study details as provided by UCB:

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 ]

Estimated Enrollment: 600
Study Start Date: March 2004
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ALPROSTADIL: Experimental
Alprostadil
Drug: Alprostadil
40 µg Alprostadil i.v. b.d. during a Treatment Phase of 4 weeks
PLACEBO: Placebo Comparator
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

Contacts
Contact: UCB Clinical Trial Call Center +1 877 822 9493

Locations
Germany
Recruiting
Karlsbad, Germany
Recruiting
Mannheim, Germany
Poland
Recruiting
Szczecin, Poland
Recruiting
Bydgoszcz, Poland
Recruiting
Poznan, Poland
Recruiting
Wroclaw, Poland
Recruiting
Lublin, Poland
Recruiting
Warszawa, Poland
Recruiting
Krakow, Poland
Recruiting
Konskie, Poland
Recruiting
Zamosc, Poland
Russian Federation
Recruiting
Moscow, Russian Federation
Recruiting
St Petersburg, Russian Federation
Recruiting
Omsk, Russian Federation
Recruiting
Chelyabinsk, Russian Federation
Recruiting
Jaroslavl, Russian Federation
Recruiting
Rostov-on-Don, Russian Federation
Recruiting
Ekaterinburg, Russian Federation
Recruiting
Rjazan, Russian Federation
Recruiting
Kemerovo, Russian Federation
Recruiting
Irkutsk, Russian Federation
Recruiting
Tver, Russian Federation
Recruiting
Tumen', Russian Federation
Completed
Lipetsk, Russian Federation
Recruiting
Saratov, Russian Federation
Recruiting
Novosibirsk, Russian Federation
Recruiting
Volgograd, Russian Federation
Recruiting
Petrozavodsk, Russian Federation
Recruiting
Samara, Russian Federation
Ukraine
Recruiting
Kiev, Ukraine
Recruiting
Dnepropetrovsk, Ukraine
Recruiting
Zaporozhye, Ukraine
Recruiting
Donetsk, Ukraine
Recruiting
Lviv, Ukraine
Sponsors and Collaborators
UCB
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB ( Study Director )
Study ID Numbers: SP777
Study First Received: December 21, 2007
Last Updated: May 11, 2009
ClinicalTrials.gov Identifier: NCT00596752     History of Changes
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 and Social Development of the Russian Federation

Keywords provided by UCB:
Alprostadil
Prostavasin

Study placed in the following topic categories:
Alprostadil
Arterial Occlusive Diseases
Vasodilator Agents
Fibrin Modulating Agents
Vascular Diseases
 Platelet Aggregation Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Ischemia

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Alprostadil
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
 Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents
Therapeutic Uses
Cardiovascular Diseases
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on July 02, 2009



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