Trial record 1 of 1 for:
NCT00596752
Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV (ESPECIAL)
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| ClinicalTrials.gov Identifier: NCT00596752 |
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Recruitment Status :
Completed
First Posted : January 17, 2008
Results First Posted : August 12, 2014
Last Update Posted : April 4, 2018
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Sponsor:
UCB BIOSCIENCES GmbH
Collaborator:
Aptiv Solutions
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Peripheral Arterial Occlusive Disease | Drug: Alprostadil Other: Placebo | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 840 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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) |
| Study Start Date : | March 2004 |
| Actual Primary Completion Date : | May 2013 |
| Actual Study Completion Date : | July 2013 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Alprostadil
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Alprostadil
Other Name: Prostavasin |
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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.
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Other: Placebo
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Primary Outcome Measures :
- 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 ]The assessment of ulcer area was collected per lesion with up to 2 lesions per subject (both legs could be affected). In the analysis a subject is only considered completely healed at a time point, if all ischemic lesions are reported as completely healed at that time point.
- 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 ]Assessment of amputations was collected per leg affected by a lesion with up to 2 lesions per subject. Amputations were regarded as major if they were performed at the ankle joint level or above. Amputations of toes or part of the foot leaving a stump thereon the subject can walk were regarded as minor. An affected leg is defined as a leg with at least 1 lesion on Study Day -6 to -2 and only amputations of affected legs are considered in the efficacy analysis of amputations. A subject is counted as major/minor amputated, if at least 1 affected leg was major/minor amputated.
Secondary Outcome Measures :
- 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 ]The assessment of ulcer area was collected per lesion with up to 2 lesions per subject (both legs could be affected). In the analysis a subject is only considered completely healed at a time point, if all ischemic lesions are reported as completely healed at that time point.
- 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 ]Visit values of intensity of rest pain from a visual analogue scale, ranging from 0 mm (no pain) to 100 mm (maximum conceivable pain), had to be reported in the case of presence of rest pain only. If the leading question in regard to the presence of rest pain is answered with "No" and no visit value is specified, the visit value will be set to 0 for the analysis.
- 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 ]In case of two ulcers the worse ulcer status is analyzed. The categories of investigator assessment are: complete healing, decrease by ≥ 50 %, unchanged, increase by ≥ 50 %.
- 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) ]The number of subjects who used analgesics are summarized for different time points/intervals during the course of the study.
- 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 ]Systolic pressure at ankle level was measured at the Arteria tibialis posterior and the Arteria dorsalis pedis. Two individual series of measurements of arterial pressures per subject across the assessed visits were selected for the analysis. For the first analysis (worst change analysis) the series of measurements in the one artery which has the worst change from Baseline at the final measurement was used. For the second analysis (worst value analysis) the series of measurements which has the worst final post-Baseline measurement was used. The series relevant for the analyses was selected from the series for the affected leg or legs only. The selection is 1 out of up to 4 series available per subject. Series without Baseline value and series with at least 1 measurement of more than 150 mmHg were excluded from the selection process due to the suspicion of media sclerosis of the lower limb artery.
- Minor Amputations at 24 Weeks After the End of Study Drug Treatment [ Time Frame: At 24 weeks after the end of study drug treatment ]
Assessment of amputations was collected per leg affected by a lesion with up to 2 lesions per subject. Amputations were regarded as major if they were performed at the ankle joint level or above. Amputations of toes or part of the foot leaving a stump thereon the subject can walk were regarded as minor. An affected leg is defined as a leg with at least 1 lesion on Study Day -6 to -2 and only amputations of affected legs are considered in the efficacy analysis of amputations. A subject is counted as major/minor amputated, if at least 1 affected leg was major/minor amputated.
The number of subjects with minor amputation prior to or at 24 weeks after the end of study drug treatment is presented below.
- Revascularization Procedures at 24 Weeks After the End of Study Drug Treatment [ Time Frame: At 24 weeks after the end of study drug treatment ]The number of subjects with revascularization prior to or at 24 weeks after the end of study drug treatment is presented below.
- 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) ]
- Cardiovascular Mortality During the Course of the Study (up to 196 Days) [ Time Frame: During the course of the study (up to 196 days) ]
- Cardiovascular Morbidity During the Course of the Study (up to 196 Days) [ Time Frame: During the course of the study (up to 196 days) ]Cardiovascular morbidity is presented as number of subjects with myocardial infarction and/or stroke during the course of the study.
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| Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00596752
Locations
Show 78 study locations
Sponsors and Collaborators
UCB BIOSCIENCES GmbH
Aptiv Solutions
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Additional Information:
Publications of Results:
Publications of Results:
| Responsible Party: | UCB BIOSCIENCES GmbH |
| ClinicalTrials.gov Identifier: | NCT00596752 |
| Other Study ID Numbers: |
SP0777 2005-001970-29 ( EudraCT Number ) |
| First Posted: | January 17, 2008 Key Record Dates |
| Results First Posted: | August 12, 2014 |
| Last Update Posted: | April 4, 2018 |
| Last Verified: | March 2018 |
Keywords provided by UCB Pharma ( UCB BIOSCIENCES GmbH ):
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Alprostadil Prostavasin PAOD Fontaine Stage IV |
Additional relevant MeSH terms:
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Arterial Occlusive Diseases Peripheral Arterial Disease Vascular Diseases Cardiovascular Diseases Atherosclerosis Arteriosclerosis |
Peripheral Vascular Diseases Alprostadil Platelet Aggregation Inhibitors Vasodilator Agents Urological Agents |