Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00596752
• Date of registration: 21/12/2007
• Prospective Registration: No
• Primary sponsor: UCB BIOSCIENCES GmbH
• Public title: Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV ESPECIAL
• Scientific 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)
• Date of first enrolment: March 2004
• Target sample size: 840
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00596752
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

Czech Republic, Czechia, Germany, Mexico, Poland, Russian Federation, Ukraine

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: [phone] (UCB)

Key inclusion & exclusion criteria

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



Age minimum: 45 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral Arterial Occlusive Disease

Intervention(s)

Drug: Alprostadil

Other: Placebo

Primary Outcome(s)

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]

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]

Secondary Outcome(s)

Cardiovascular Mortality During the Course of the Study (up to 196 Days) [Time Frame: During the course of the study (up to 196 days)]

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)]

Minor Amputations at 24 Weeks After the End of Study Drug Treatment [Time Frame: At 24 weeks after the end of study drug treatment]

Cardiovascular Morbidity During the Course of the Study (up to 196 Days) [Time Frame: During the course of the study (up to 196 days)]

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)]

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]

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]

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]

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]

Revascularization Procedures at 24 Weeks After the End of Study Drug Treatment [Time Frame: At 24 weeks after the end of study drug treatment]

Secondary ID(s)

2005-001970-29

SP0777

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Aptiv Solutions

Results

• Results available: Yes
• Date Posted: 12/08/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00596752