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

This study has been completed.
Sponsor:
Collaborator:
Aptiv Solutions
Information provided by (Responsible Party):
UCB, Inc. ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier:
NCT00596752
First received: December 21, 2007
Last updated: March 27, 2014
Last verified: March 2014

December 21, 2007
March 27, 2014
March 2004
May 2013   (final data collection date for primary outcome measure)
  • Complete healing of ischemic necroses and ulcerations at 12 weeks after the end of study drug treatment [ Time Frame: At 12 weeks after the end of study drug treatment ] [ Designated as safety issue: No ]
  • Occurrence of major amputations at 24 weeks after the end of study drug treatment [ Time Frame: At 24 weeks after the end of study drug treatment ] [ Designated as safety issue: No ]
  • Rate of complete healing of ulcerations after 12 weeks [ Time Frame: 12 weeks ]
  • Frequency of amputations after 24 weeks [ Time Frame: 24 weeks ]
Complete list of historical versions of study NCT00596752 on ClinicalTrials.gov Archive Site
  • Complete healing of ischemic necroses and ulcerations at 24 weeks after the end of study drug treatment [ Time Frame: At 24 weeks after the end of study drug treatment ] [ Designated as safety issue: No ]
  • Intensity of rest pain induced by ischemic lesions at 24 weeks after the end of study drug treatment [ Time Frame: At 24 weeks after the end of study drug treatment ] [ Designated as safety issue: No ]
  • Increase/decrease in ulcer area of ≥ 50 % at 24 weeks after the end of study drug treatment [ Time Frame: At 24 weeks after the end of study drug treatment ] [ Designated as safety issue: No ]
  • Consumption and type of analgesic medication during the course of the study (up to 196 days) [ Time Frame: During the course of the study (up to 196 days) ] [ Designated as safety issue: No ]
  • Systolic pressure at ankle level at 24 weeks after the end of study drug treatment [ Time Frame: At 24 weeks after the end of study drug treatment ] [ Designated as safety issue: No ]
  • Minor amputations at 24 weeks after the end of study drug treatment [ Time Frame: At 24 weeks after the end of study drug treatment ] [ Designated as safety issue: No ]
  • Revascularization procedures at 24 weeks after the end of study drug treatment [ Time Frame: At 24 weeks after the end of study drug treatment ] [ Designated as safety issue: No ]
  • All-cause mortality during the course of the study (up to 196 days) [ Time Frame: During the course of the study (up to 196 days) ] [ Designated as safety issue: No ]
  • Cardiovascular mortality during the course of the study (up to 196 days) [ Time Frame: During the course of the study (up to 196 days) ] [ Designated as safety issue: No ]
  • Cardiovascular morbidity during the course of the study (up to 196 days) [ Time Frame: During the course of the study (up to 196 days) ] [ Designated as safety issue: No ]
Rate of complete healing of all necroses and ulcerations; Intensity of rest pain; Consumption and type of analgesics; minor amputations [ Time Frame: 24 weeks ]
Not Provided
Not Provided
 
Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV
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)

The study is to confirmatorily show a superior effect of Alprostadil compared to placebo on the rate of complete healing of ischemic necroses and ulcerations as well as on the frequency and height of major amputations in patients suffering from PAOD stage IV.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Peripheral Arterial Occlusive Disease
  • Drug: Alprostadil
    • Active Substance: Prostaglandin E1
    • Pharmaceutical Form: solution for infusion
    • Concentration: 40 μg b.d.
    • Route of Administration: intravenous infusion
    Other Name: Prostavasin
  • Other: Placebo
    • Active Substance: Lactose
    • Pharmaceutical Form: solution for infusion
    • Concentration: 40 μg b.d.
    • Route of Administration: intravenous infusion
  • Experimental: Alprostadil
    Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
    Intervention: Drug: Alprostadil
  • Placebo Comparator: Placebo
    Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
840
July 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is at least 45 years of age
  • Subjects with macro-angiopathy, proven PAOD Stage IV with up to 2 ischaemic skin lesions for more than 2 weeks
  • Subject has a complete angiography of pelvis, thigh and calf within one month of inclusion
  • Systolic ankle pressure ≤ 70 mmHg in subjects without media sclerosis of the lower limb artery or systolic big toe pressure ≤ 50 mmHg in diabetics with media sclerosis of the lower limb artery
  • Subject is not in the position to be primarily revascularized or refuses surgery

Exclusion Criteria:

  • Imminent or foreseeable amputation
  • Major amputation on the affected extremity
  • History of chronic alcohol or drug abuse
  • More than two ischemic ulcerations
  • One ulcer ≥ 6 cm^2, both ulcers ≤ 1 cm^2 or at least one ulcer affecting the bone or tendons
  • Acute ischemia and peripheral vascular disorders of inflammatory or immunologic origin
  • Neuropathic or venous ulcers
  • Buerger's disease
  • Septic gangrene
  • Use of vasoactive medication or prostaglandins
  • Treatment with prostanoids within 3 months prior to inclusion
  • Surgical or interventional measures performed on the affected extremity within 3 months prior to study drug treatment
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany,   Mexico,   Poland,   Russian Federation,   Ukraine
 
NCT00596752
SP777, 2005-001970-29
Yes
UCB, Inc. ( UCB BIOSCIENCES GmbH )
UCB BIOSCIENCES GmbH
Aptiv Solutions
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP