Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV - Tabular View

Tracking Information

First Received Date ^ICMJE

December 21, 2007

Last Updated Date

October 1, 2009

Start Date ^ICMJE

March 2004

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Rate of complete healing of ulcerations after 12 weeks [ Time Frame: 12 weeks ]
Frequency of amputations after 24 weeks [ Time Frame: 24 weeks ]

Change History

Complete list of historical versions of study NCT00596752 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

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

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

Drug: Alprostadil
Other: Placebo

Study Arms / Comparison Groups

Experimental: Alprostadil
Placebo Comparator: Placebo treatment

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

840

Estimated Completion Date

June 2012

Estimated Primary Completion Date

June 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

Gender

Both

Ages

45 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: UCB Clinical Trial Call Center

+1 877 822 9493

Location Countries ^ICMJE

Germany, Poland, Russian Federation, Ukraine

Administrative Information

NCT ID ^ICMJE

NCT00596752

Responsible Party

Study Director, UCB

Study ID Numbers ^ICMJE

SP777

Study Sponsor ^ICMJE

UCB, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

Information Provided By

UCB, Inc.

Verification Date

October 2009

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