Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV (ESPECIAL)
Tracking Information
Start Date ICMJE | March 2004 |
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Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: May 11, 2009) |
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Original Primary Outcome Measures ICMJE (submitted: January 16, 2008) |
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Change History | Complete list of historical versions of study NCT00596752 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: May 11, 2009) | 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 ] |
Original Secondary Outcome Measures ICMJE (submitted: January 16, 2008) | Rate of complete healing of all necroses and ulcerations; Intensity of rest pain; Consumption and type of analgesics; minor amputations [ Time Frame: 24 weeks ] |
Descriptive Information
Brief Title ICMJE | Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV |
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Official Title ICMJE | 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 |
Brief Summary | 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. |
Detailed Description | |
Study Phase | Phase IV |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Peripheral Arterial Occlusive Disease |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 840 | ||||
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Estimated Completion Date | June 2012 | ||||
Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 45 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Germany, Poland, Russian Federation, Ukraine |
Administrative Information
NCT ID ICMJE | NCT00596752 | ||||
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Responsible Party | Study Director, UCB | ||||
Study ID Numbers ICMJE | SP777 | ||||
Study Sponsor ICMJE | UCB, Inc. | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | UCB, Inc. |
Source: http://clinicaltrials.gov/