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Investigate, under outpatient conditions, both the effect of 4 weeks of daily treatment with Prostaglandin E1 and that of 4 weeks of interval treatment (two infusions per week) on the pain-free walking distance in patients with Intermittent Claudication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alprostadil | Experimental | Alprostadil (Prostaglandin E1) intravenous and matching Placebo to Pentoxifylline oral |
|
| Pentoxifylline | Active Comparator | Pentoxifylline oral and matching Placebo to Alprostadil (Prostaglandin E1) intravenous |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alprostadil (Prostaglandin E1) | Drug | 4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 µg) of Prostaglandin E1 (total 60 µg) in 50 - 250 ml physiological saline solution over 2 hours. 4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 µg) of Prostaglandin E1 (total 60 µg) in 50 - 250 ml physiological saline solution over 2 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings at Baseline | 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. | From Baseline to the end of 4 weeks of Interval Treatment (Period 2) |
| Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings at Baseline | 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. | From Baseline to the end of 6-months Follow-up (Period 3) |
| Ratio of Pain-free Walking Distance After Period 1 in Comparison With the Findings at Baseline | 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. | From Baseline to the end of 4 weeks of Daily Treatment (Period 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings After Period 1 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aachen | Germany | |||||
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Participant Flow shows all randomized subjects. Baseline Characteristics refer to the FAS.
Of the 607 screened subjects, 561 have been randomized. Of these 561 randomized subjects, 541 are included in the Full Analysis Set (FAS). FAS includes all randomized subjects who received at least one dose of trial medication and who have at least one valid measurement of pain-free walking distance under therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alprostadil | 4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets. 4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Pentoxifylline | Drug | 4-week Daily Treatment Period 1: 4 weeks of 2 x daily (including weekends) 600 mg Pentoxifylline tablets. 4-week Interval Treatment Period 2: 4 weeks of 2 x daily (including weekends) 600 mg Pentoxifylline tablets. |
|
|
| Placebo to Pentoxifylline oral | Drug | 4-week Daily Treatment Period 1: 4 weeks of 2 x daily (including weekends) matching Placebo to Pentoxifylline tablets. 4-week Interval Treatment Period 2: 4 weeks of 2 x daily (including weekends) matching Placebo to Pentoxifylline tablets. |
|
| Placebo to Alprostadil (Prostaglandin E1) intravenous | Drug | 4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours. 4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours. |
|
| From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2) |
| Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 1 | 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. | From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3) |
| Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 2 | 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. | From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3) |
| Ratio of Maximum Walking Distance After Period 1 in Comparison With the Findings at Baseline | 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. | From Baseline to the end of 4 weeks of Daily Treatment (Period 1) |
| Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings at Baseline | 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. | From Baseline to the end of 4 weeks of Interval Treatment (Period 2) |
| Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings After Period 1 | 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. | From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2) |
| Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings at Baseline | 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. | From Baseline to the end of 6-months Follow-up (Period 3) |
| Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 1 | The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 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. | From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3) |
| Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 2 | The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance after Period 2 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. | From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3) |
| Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1 | Scores for subscales were calculated by summing non-missing item scores ranging from 1 (not at all; best possible outcome) to 4 (extremely; worst possible outcome) divided by the number of non-missing items. Hence each subscale score ranges from 1 (best possible outcome) to 4 (worst possible outcome). For subscales 'Mood' and 'Treatment expectation' five items each had to be reversed in order. Additionally, subjects were asked to assess their general health and quality of life on an ordinal scale between 0 (very good) and 10 (very poor). Negative changes show a decrease from Baseline. | From Baseline to the end of 4 weeks of Daily Treatment (Period 1) |
| Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3 | Scores for subscales were calculated by summing non-missing item scores ranging from 1 (not at all; best possible outcome) to 4 (extremely; worst possible outcome) divided by the number of non-missing items. Hence each subscale score ranges from 1 (best possible outcome) to 4 (worst possible outcome). For subscales 'Mood' and 'Treatment expectation' five items each had to be reversed in order. Additionally, subjects were asked to assess their general health and quality of life on an ordinal scale between 0 (very good) and 10 (very poor). Negative changes show a decrease from Baseline. | From Baseline to the end of 6-months Follow-up (Period 3) |
| Bad Säckingen |
| Germany |
| Berlin | Germany |
| Bottrop | Germany |
| Cologne | Germany |
| Dortmund | Germany |
| Dresden | Germany |
| Düsseldorf | Germany |
| Essen | Germany |
| Essen-Steele | Germany |
| Freiburg im Breisgau | Germany |
| Gaggenau | Germany |
| Görlitz | Germany |
| Hamburg | Germany |
| Hanover | Germany |
| Hattingen | Germany |
| Heidelberg | Germany |
| Homburg | Germany |
| Jena | Germany |
| Karlsbad-Lang Ensteinbach | Germany |
| Kassel | Germany |
| Krefeld | Germany |
| Leipzig | Germany |
| Lüneburg | Germany |
| Mannheim | Germany |
| Mannheim-Lindenhof | Germany |
| Mönchengladbach | Germany |
| München | Germany |
| Neuss | Germany |
| Nuremberg | Germany |
| Osnabrück | Germany |
| Papenburg | Germany |
| Regensburg | Germany |
| Seesen | Germany |
| Warendorf | Germany |
| Wuppertal | Germany |
| FG001 | Pentoxifylline | 4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets. 4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets. |
| Full Analysis Set |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alprostadil | 4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets. 4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets. |
| BG001 | Pentoxifylline | 4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets. 4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity | Number | participants |
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| Age categories | Number | participants |
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| Weight | Mean | Standard Deviation | kilogram (kg) |
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| Height | Mean | Standard Deviation | centimeter (cm) |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram/ meter^2 (kg/m^2) |
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| Duration of Primary Disease | Mean | Standard Deviation | years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings at Baseline | 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. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | meter/meter | From Baseline to the end of 4 weeks of Interval Treatment (Period 2) |
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| Primary | Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings at Baseline | 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. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | meter/meter | From Baseline to the end of 6-months Follow-up (Period 3) |
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| Primary | Ratio of Pain-free Walking Distance After Period 1 in Comparison With the Findings at Baseline | 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. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | meter/meter | From Baseline to the end of 4 weeks of Daily Treatment (Period 1) |
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| Secondary | Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings After Period 1 | 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. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | meter/meter | From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2) |
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| Secondary | Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 1 | 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. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | meter/meter | From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3) |
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| Secondary | Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 2 | 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. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | meter/meter | From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3) |
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| Secondary | Ratio of Maximum Walking Distance After Period 1 in Comparison With the Findings at Baseline | 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. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | meter/meter | From Baseline to the end of 4 weeks of Daily Treatment (Period 1) |
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| Secondary | Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings at Baseline | 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. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | meter/meter | From Baseline to the end of 4 weeks of Interval Treatment (Period 2) |
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| Secondary | Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings After Period 1 | 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. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | meter/meter | From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2) |
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| Secondary | Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings at Baseline | 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. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | meter/meter | From Baseline to the end of 6-months Follow-up (Period 3) |
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| Secondary | Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 1 | The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 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. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | meter/meter | From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3) |
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| Secondary | Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 2 | The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance after Period 2 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. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | meter/meter | From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3) |
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| Secondary | Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1 | Scores for subscales were calculated by summing non-missing item scores ranging from 1 (not at all; best possible outcome) to 4 (extremely; worst possible outcome) divided by the number of non-missing items. Hence each subscale score ranges from 1 (best possible outcome) to 4 (worst possible outcome). For subscales 'Mood' and 'Treatment expectation' five items each had to be reversed in order. Additionally, subjects were asked to assess their general health and quality of life on an ordinal scale between 0 (very good) and 10 (very poor). Negative changes show a decrease from Baseline. | Full Analysis Set (FAS). For each subscale of the questionnaire, Mean and SD are presented for non-missing values. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to the end of 4 weeks of Daily Treatment (Period 1) |
| ||||||||||||||||||||||||||||||
| Secondary | Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3 | Scores for subscales were calculated by summing non-missing item scores ranging from 1 (not at all; best possible outcome) to 4 (extremely; worst possible outcome) divided by the number of non-missing items. Hence each subscale score ranges from 1 (best possible outcome) to 4 (worst possible outcome). For subscales 'Mood' and 'Treatment expectation' five items each had to be reversed in order. Additionally, subjects were asked to assess their general health and quality of life on an ordinal scale between 0 (very good) and 10 (very poor). Negative changes show a decrease from Baseline. | Full Analysis Set (FAS). For each subscale of the questionnaire, Mean and SD are presented for non-missing values. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to the end of 6-months Follow-up (Period 3) |
|
Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication.
Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alprostadil | 4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets. 4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets. | 19 | 276 | 60 | 276 | ||
| EG001 | Pentoxifylline | 4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets. 4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets. | 17 | 285 | 55 | 285 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Left Ventricular Failure | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Cardiac Failure | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Ischaemic Cardiomyopathy | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Acute Myocardial Infarction | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cardiac Failure Acute | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Tachycardia Paroxysmal | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Vestibular Disorder | Ear and labyrinth disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Chest Pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Device Related Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Postoperative Wound Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Gangrene | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Tinea Pedis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Head Injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cardiac Enzymes Increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bronchial Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
| |
| Prostatic Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
| |
| Carotid Artery Stenosis | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Intercostal Neuralgia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Suicide Attempt | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Renal Failure Chronic | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Genital Haemorrhage | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Extremity Necrosis | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Peripheral Ischaemia | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Infusion Site Irritation | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Infusion Site Swelling | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Infusion Site Erythema | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Infusion Site Extravasation | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Infusion Site Haematoma | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Tooth Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Blood Glucose Increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Blood Triglycerides Increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Musculoskeletal Discomfort | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sleep Disorder | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +1 877 822 9493 (UCB) |
| ID | Term |
|---|---|
| C564658 | Peripheral Arterial Occlusive Disease 1 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000527 | Alprostadil |
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D005229 | Fatty Acids, Monounsaturated |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
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| Asian |
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| >=65 - <75 |
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| >=75 |
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4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
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4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
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