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Sponsored by: |
UCB |
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Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00596752 |
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 |
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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 |
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 |
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ALPROSTADIL: Experimental
Alprostadil
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Drug: Alprostadil
40 µg Alprostadil i.v. b.d. during a Treatment Phase of 4 weeks
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PLACEBO: Placebo Comparator
Placebo treatment
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Other: Placebo
Placebo i.v. b.d. during a Treatment Phase of 4 weeks
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Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: UCB Clinical Trial Call Center | +1 877 822 9493 |
Germany | |
Recruiting | |
Karlsbad, Germany | |
Recruiting | |
Mannheim, Germany | |
Poland | |
Recruiting | |
Bydgoszcz, Poland | |
Recruiting | |
Konskie, Poland | |
Recruiting | |
Szczecin, Poland | |
Recruiting | |
Lublin, Poland | |
Recruiting | |
Poznan, Poland | |
Recruiting | |
Krakow, Poland | |
Recruiting | |
Warszawa, Poland | |
Recruiting | |
Wroclaw, Poland | |
Recruiting | |
Zamosc, Poland | |
Russian Federation | |
Recruiting | |
Chelyabinsk, Russian Federation | |
Recruiting | |
Ekaterinburg, Russian Federation | |
Completed | |
Lipetsk, Russian Federation | |
Recruiting | |
Jaroslavl, Russian Federation | |
Recruiting | |
Kemerovo, Russian Federation | |
Recruiting | |
Irkutsk, Russian Federation | |
Recruiting | |
Moscow, Russian Federation | |
Recruiting | |
Novosibirsk, Russian Federation | |
Recruiting | |
Omsk, Russian Federation | |
Recruiting | |
Petrozavodsk, Russian Federation | |
Recruiting | |
Rjazan, Russian Federation | |
Recruiting | |
St Petersburg, Russian Federation | |
Recruiting | |
Samara, Russian Federation | |
Recruiting | |
Saratov, Russian Federation | |
Recruiting | |
Rostov-on-Don, Russian Federation | |
Recruiting | |
Tumen', Russian Federation | |
Recruiting | |
Tver, Russian Federation | |
Recruiting | |
Volgograd, Russian Federation | |
Ukraine | |
Recruiting | |
Dnepropetrovsk, Ukraine | |
Recruiting | |
Zaporozhye, Ukraine | |
Recruiting | |
Kiev, Ukraine | |
Recruiting | |
Lviv, Ukraine | |
Recruiting | |
Donetsk, Ukraine |
Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Responsible Party: | UCB ( Study Director ) |
Study ID Numbers: | SP777 |
Study First Received: | December 21, 2007 |
Last Updated: | July 31, 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 |
Alprostadil Prostavasin |
Alprostadil Arterial Occlusive Diseases Vasodilator Agents Fibrin Modulating Agents Vascular Diseases |
Platelet Aggregation Inhibitors Fibrinolytic Agents Cardiovascular Agents Ischemia |
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 |