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


Tracking Information

Start Date  ICMJEMarch 2004
Estimated Primary Completion DateJune 2012   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: May 11, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJE 
 (submitted: January 16, 2008)
  • Rate of complete healing of ulcerations after 12 weeks [ Time Frame: 12 weeks ]
  • Frequency of amputations after 24 weeks [ Time Frame: 24 weeks ]
Change HistoryComplete 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  ICMJEAlprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV
Official Title  ICMJEMultinational, 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 PhasePhase IV
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEPeripheral Arterial Occlusive Disease
Intervention  ICMJE
  • Drug: Alprostadil
    40 µg Alprostadil i.v. b.d. during a Treatment Phase of 4 weeks
  • Other: Placebo
    Placebo i.v. b.d. during a Treatment Phase of 4 weeks
Study Arms / Comparison Groups
  • ALPROSTADIL: Experimental
    Alprostadil
    Intervention: Drug: Alprostadil
  • PLACEBO: Placebo Comparator
    Placebo treatment
    Intervention: Other: Placebo

Recruitment Information

Estimated Enrollment  ICMJE840
Estimated Completion DateJune 2012
Estimated Primary Completion DateJune 2012   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages45 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: UCB Clinical Trial Call Center+1 877 822 9493
Location Countries  ICMJEGermany,   Poland,   Russian Federation,   Ukraine

Administrative Information

NCT ID  ICMJENCT00596752
Responsible PartyStudy Director, UCB
Study ID Numbers  ICMJESP777
Study Sponsor  ICMJEUCB, Inc.
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:UCB Clinical Trial Call Center+1 877 822 9493 (UCB)
Information Provided ByUCB, Inc.