Trial · NCT01263925
Prostaglandin E1 in Outpatients With Intermittent Claudication
NCT01263925, Phase 3, Completed, UCB Pharma; results first posted 2012-06-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Prostaglandin E1 in Outpatients With Intermittent Claudication. Trials, record NCT01263925. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01263925
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prostaglandin E1 in Outpatients With Intermittent Claudication
- NCT number
- NCT01263925
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 561 participants, actual
- Lead sponsor
- UCB Pharma
- Conditions
- Stage II Peripheral Arterial Occlusive Disease, Intermittent Claudication Fontaine Stage II PAOD
- Interventions
- Alprostadil (Prostaglandin E1), Pentoxifylline, Placebo to Pentoxifylline oral, Placebo to Alprostadil (Prostaglandin E1) intravenous
- First posted
- 2010-12-21
- Last updated
- 2014-10-27
- Results first posted
- 2012-06-29
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings at Baseline | From Baseline to the end of 4 weeks of Interval Treatment (Period 2) | The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 2 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved. |
| Primary | Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings at Baseline | From Baseline to the end of 6-months Follow-up (Period 3) | The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved. |
| Primary | Ratio of Pain-free Walking Distance After Period 1 in Comparison With the Findings at Baseline | From Baseline to the end of 4 weeks of Daily Treatment (Period 1) | The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 1 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved. |
| Secondary | Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings After Period 1 | From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2) | The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 2 divided by the pain-free walking distance after Period 1 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved. |
| Secondary | Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 1 | From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3) | The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance after Period 1 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved. |
| Secondary | Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 2 | From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3) | The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance after Period 2 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved. |
| Secondary | Ratio of Maximum Walking Distance After Period 1 in Comparison With the Findings at Baseline | From Baseline to the end of 4 weeks of Daily Treatment (Period 1) | The ratio of maximum walking distance was calculated by the maximum walking distance after Period 1 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved. |
| Secondary | Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings at Baseline | From Baseline to the end of 4 weeks of Interval Treatment (Period 2) | The ratio of maximum walking distance was calculated by the maximum walking distance after Period 2 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved. |
| Secondary | Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings After Period 1 | From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2) | The ratio of maximum walking distance was calculated by the maximum walking distance after Period 2 divided by the maximum walking distance after Period 1 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved. |
| Secondary | Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings at Baseline | From Baseline to the end of 6-months Follow-up (Period 3) | The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings at Baseline | From Baseline to the end of 4 weeks of Interval Treatment (Period 2) | Full Analysis Set (FAS). | meter/meter | MEAN |
| PRIMARY | Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings at Baseline | From Baseline to the end of 6-months Follow-up (Period 3) | Full Analysis Set (FAS). | meter/meter | MEAN |
| PRIMARY | Ratio of Pain-free Walking Distance After Period 1 in Comparison With the Findings at Baseline | From Baseline to the end of 4 weeks of Daily Treatment (Period 1) | Full Analysis Set (FAS). | meter/meter | MEAN |
| SECONDARY | Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings After Period 1 | From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2) | Full Analysis Set (FAS). | meter/meter | MEAN |
| SECONDARY | Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 1 | From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3) | Full Analysis Set (FAS). | meter/meter | MEAN |
| SECONDARY | Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 2 | From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3) | Full Analysis Set (FAS). | meter/meter | MEAN |
| SECONDARY | Ratio of Maximum Walking Distance After Period 1 in Comparison With the Findings at Baseline | From Baseline to the end of 4 weeks of Daily Treatment (Period 1) | Full Analysis Set (FAS). | meter/meter | MEAN |
| SECONDARY | Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings at Baseline | From Baseline to the end of 4 weeks of Interval Treatment (Period 2) | Full Analysis Set (FAS). | meter/meter | MEAN |
| SECONDARY | Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings After Period 1 | From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2) | Full Analysis Set (FAS). | meter/meter | MEAN |
| SECONDARY | Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings at Baseline | From Baseline to the end of 6-months Follow-up (Period 3) | Full Analysis Set (FAS). | meter/meter | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings at Baseline | Alprostadil | 2.60 | Standard Deviation 12.22 | meter/meter | |
| Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings at Baseline | Pentoxifylline | 1.98 | Standard Deviation 3.61 | meter/meter | |
| Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings at Baseline | Alprostadil | 2.27 | Standard Deviation 3.00 | meter/meter | |
| Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings at Baseline | Pentoxifylline | 2.36 | Standard Deviation 2.69 | meter/meter | |
| Ratio of Pain-free Walking Distance After Period 1 in Comparison With the Findings at Baseline | Alprostadil | 1.58 | Standard Deviation 1.92 | meter/meter | |
| Ratio of Pain-free Walking Distance After Period 1 in Comparison With the Findings at Baseline | Pentoxifylline | 1.58 | Standard Deviation 2.59 | meter/meter | |
| Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings After Period 1 | Alprostadil | 1.25 | Standard Deviation 0.64 | meter/meter | |
| Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings After Period 1 | Pentoxifylline | 1.24 | Standard Deviation 0.50 | meter/meter | |
| Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 1 | Alprostadil | 1.54 | Standard Deviation 1.53 | meter/meter | |
| Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 1 | Pentoxifylline | 1.57 | Standard Deviation 1.10 | meter/meter |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 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 | 276 | |
| Overall Study | STARTED | Pentoxifylline | 285 | |
| Overall Study | Full Analysis Set | Alprostadil | 269 | |
| Overall Study | Full Analysis Set | Pentoxifylline | 272 | |
| Overall Study | COMPLETED | Alprostadil | 225 | |
| Overall Study | COMPLETED | Pentoxifylline | 233 | |
| Overall Study | NOT COMPLETED | Alprostadil | 51 | |
| Overall Study | NOT COMPLETED | Pentoxifylline | 52 |
Source ClinicalTrials.gov
Adverse events160
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 | Angina Pectoris | Cardiac disorders | Alprostadil | 0 | 276 | 0 |
| other | Angina Pectoris | Cardiac disorders | Pentoxifylline | 4 | 285 | 4 |
| other | Vertigo | Ear and labyrinth disorders | Alprostadil | 2 | 276 | 2 |
| other | Vertigo | Ear and labyrinth disorders | Pentoxifylline | 5 | 285 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Alprostadil | 3 | 276 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Pentoxifylline | 4 | 285 | 5 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Alprostadil | 2 | 276 | 2 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Pentoxifylline | 6 | 285 | 6 |
| other | Gastritis | Gastrointestinal disorders | Alprostadil | 2 | 276 | 2 |
| other | Gastritis | Gastrointestinal disorders | Pentoxifylline | 0 | 285 | 0 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 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 | Pentoxifylline | ||
| Total, other adverse events | Alprostadil | 60 | 276 |
| Total, other adverse events | Pentoxifylline | 55 | 285 |
| Total, serious adverse events | Alprostadil | 19 | 276 |
| Total, serious adverse events | Pentoxifylline | 17 | 285 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Alprostadil vs Pentoxifylline: serious adverse events |
Source 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01263925
GET https://conductscience.org/api/trials/v1/NCT01263925/results?page=2