Trial · NCT00596752
Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV
NCT00596752, Phase 4, Completed, UCB BIOSCIENCES GmbH; results first posted 2014-08-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV. Trials, record NCT00596752. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00596752
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV
- NCT number
- NCT00596752
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 840 participants, actual
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Conditions
- Peripheral Arterial Occlusive Disease
- Interventions
- Alprostadil, Placebo
- First posted
- 2008-01-17
- Last updated
- 2018-04-04
- Other registries' IDs
- eudract:2005-001970-29
- Results first posted
- 2014-08-12
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment | 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. |
| Primary | Occurrence of Major Amputations at 24 Weeks After the End of Study Drug Treatment | 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 | Complete Healing of Ischemic Necroses and Ulcerations at 24 Weeks After the End of Study Drug Treatment | 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. |
| Secondary | Intensity of Rest Pain Induced by Ischemic Lesions at 24 Weeks After the End of Study Drug Treatment | 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. |
| Secondary | Increase/Decrease in Ulcer Area of ≥ 50 % at 24 Weeks After the End of Study Drug Treatment | 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 %. |
| Secondary | Consumption and Type of Analgesic Medication During the Course of the Study (up to 196 Days) | 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. |
| Secondary | Systolic Pressure at Ankle Level at 24 Weeks After the End of Study Drug Treatment | 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. |
| Secondary | Minor Amputations at 24 Weeks After the End of Study Drug Treatment | 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. |
| Secondary | Revascularization Procedures at 24 Weeks After the End of Study Drug Treatment | 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. |
| Secondary | All-cause Mortality During the Course of the Study (up to 196 Days) | During the course of the study (up to 196 days) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment | At 12 weeks after the end of study drug treatment | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints. | participants | NUMBER |
| PRIMARY | Occurrence of Major Amputations at 24 Weeks After the End of Study Drug Treatment | At 24 weeks after the end of study drug treatment | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints. | participants | NUMBER |
| SECONDARY | Complete Healing of Ischemic Necroses and Ulcerations at 24 Weeks After the End of Study Drug Treatment | At 24 weeks after the end of study drug treatment | Of the 838 subjects in the Full Analysis Set (FAS), 568 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints. | participants | NUMBER |
| SECONDARY | Intensity of Rest Pain Induced by Ischemic Lesions at 24 Weeks After the End of Study Drug Treatment | At 24 weeks after the end of study drug treatment | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints. | millimeters (mm) | MEAN |
| SECONDARY | Increase/Decrease in Ulcer Area of ≥ 50 % at 24 Weeks After the End of Study Drug Treatment | At 24 weeks after the end of study drug treatment | Of the 838 subjects in the Full Analysis Set (FAS), 465 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints. | participants | NUMBER |
| SECONDARY | Consumption and Type of Analgesic Medication During the Course of the Study (up to 196 Days) | During the course of the study (up to 196 days) | Full Analysis Set (FAS) consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints. | participants | NUMBER |
| SECONDARY | Systolic Pressure at Ankle Level at 24 Weeks After the End of Study Drug Treatment | At 24 weeks after the end of study drug treatment | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints. | mmHg | MEAN |
| SECONDARY | Minor Amputations at 24 Weeks After the End of Study Drug Treatment | At 24 weeks after the end of study drug treatment | Of the 838 subjects in the Full Analysis Set (FAS), 613 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints. | participants | NUMBER |
| SECONDARY | Revascularization Procedures at 24 Weeks After the End of Study Drug Treatment | At 24 weeks after the end of study drug treatment | Of the 838 subjects in the Full Analysis Set (FAS), 577 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints. | participants | NUMBER |
| SECONDARY | All-cause Mortality During the Course of the Study (up to 196 Days) | During the course of the study (up to 196 days) | Safety Set consists of all randomized subjects who received at least one dose of trial medication. | participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment | Alprostadil | Stage 1 (n=253, n=251) | 49 | participants | |
| Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment | Placebo | Stage 1 (n=253, n=251) | 43 | participants | |
| Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment | Alprostadil | Stage 2 (n=161, n=173) | 27 | participants | |
| Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment | Placebo | Stage 2 (n=161, n=173) | 30 | participants | |
| Occurrence of Major Amputations at 24 Weeks After the End of Study Drug Treatment | Alprostadil | Stage 1 (n=253, n=251) | 32 | participants | |
| Occurrence of Major Amputations at 24 Weeks After the End of Study Drug Treatment | Placebo | Stage 1 (n=253, n=251) | 49 | participants | |
| Occurrence of Major Amputations at 24 Weeks After the End of Study Drug Treatment | Alprostadil | Stage 2 (n=161, n=173) | 20 | participants | |
| Occurrence of Major Amputations at 24 Weeks After the End of Study Drug Treatment | Placebo | Stage 2 (n=161, n=173) | 13 | participants | |
| Complete Healing of Ischemic Necroses and Ulcerations at 24 Weeks After the End of Study Drug Treatment | Alprostadil | 108 | participants | ||
| Complete Healing of Ischemic Necroses and Ulcerations at 24 Weeks After the End of Study Drug Treatment | Placebo | 103 | participants |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alprostadil | 415 | |
| Overall Study | STARTED | Placebo | 425 | |
| Overall Study | Randomized and Treated | Alprostadil | 415 | |
| Overall Study | Randomized and Treated | Placebo | 424 | |
| Overall Study | COMPLETED | Alprostadil | 289 | |
| Overall Study | COMPLETED | Placebo | 282 | |
| Overall Study | NOT COMPLETED | Alprostadil | 126 | |
| Overall Study | NOT COMPLETED | Placebo | 143 |
Source ClinicalTrials.gov
Adverse events172
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | SKIN ULCER | Skin and subcutaneous tissue disorders | Alprostadil | 24 | 416 | 29 |
| other | SKIN ULCER | Skin and subcutaneous tissue disorders | Placebo | 26 | 423 | 28 |
| other | PERIPHERAL ISCHAEMIA | Vascular disorders | Alprostadil | 40 | 416 | 41 |
| other | PERIPHERAL ISCHAEMIA | Vascular disorders | Placebo | 41 | 423 | 45 |
| serious | ANAEMIA | Blood and lymphatic system disorders | Alprostadil | 1 | 416 | 1 |
| serious | ANAEMIA | Blood and lymphatic system disorders | Placebo | 0 | 423 | 0 |
| serious | ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | Alprostadil | 3 | 416 | 3 |
| serious | ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | Placebo | 3 | 423 | 3 |
| serious | CARDIAC FAILURE | Cardiac disorders | Alprostadil | 3 | 416 | 3 |
| serious | CARDIAC FAILURE | Cardiac disorders | Placebo | 1 | 423 | 1 |
1 to 10 of 172Source ClinicalTrials.gov
See all 172 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alprostadil | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Alprostadil | 61 | 416 |
| Total, other adverse events | Placebo | 62 | 423 |
| Total, serious adverse events | Alprostadil | 87 | 416 |
| Total, serious adverse events | Placebo | 62 | 423 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28189475 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Alprostadil vs Placebo: Complete Healing of Ischemic Necroses and Ulcerations at 24 Weeks After the End of Study Drug Treatment | Trial comparisons |
| Alprostadil vs Placebo: Revascularization Procedures at 24 Weeks After the End of Study Drug Treatment | Trial comparisons |
| Alprostadil vs Placebo: All-cause Mortality During the Course of the Study (up to 196 Days) | Trial comparisons |
| Alprostadil vs Placebo: Cardiovascular Mortality During the Course of the Study (up to 196 Days) | Trial comparisons |
| Alprostadil vs Placebo: Minor Amputations at 24 Weeks After the End of Study Drug Treatment | Trial comparisons |
| Alprostadil vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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