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

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

This study is currently recruiting participants.

Verified February 2012 by UCB, Inc.

First Received on December 21, 2007. Last Updated on February 6, 2012 History of Changes

Sponsor:	UCB, Inc.
Information provided by (Responsible Party):	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00596752

Purpose

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
Peripheral Arterial Occlusive Disease	Drug: Alprostadil Other: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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)

Resource links provided by NLM:

Drug Information available for: Alprostadil

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	840
Study Start Date:	March 2004
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ALPROSTADIL Alprostadil	Drug: Alprostadil 40 µg Alprostadil i.v. b.d. during a Treatment Phase of 4 weeks
Placebo Comparator: PLACEBO Placebo treatment	Other: Placebo Placebo i.v. b.d. during a Treatment Phase of 4 weeks

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596752

Contacts

Contact: UCB Clinical Trial Call Center

+1 877 822 9493

Show 94 Study Locations

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00596752 History of Changes
Other Study ID Numbers:	SP777
Study First Received:	December 21, 2007
Last Updated:	February 6, 2012
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

Keywords provided by UCB, Inc.:

Alprostadil
Prostavasin

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Peripheral Arterial Disease
Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Peripheral Vascular Diseases
Alprostadil
Platelet Aggregation Inhibitors

Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012