Back to resultsProstaglandin E1 in Outpatients With Intermittent Claudication
Primary Purpose
Stage II Peripheral Arterial Occlusive Disease, Intermittent Claudication Fontaine Stage II PAOD
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Alprostadil (Prostaglandin E1)
Pentoxifylline
Placebo to Pentoxifylline oral
Placebo to Alprostadil (Prostaglandin E1) intravenous
Sponsored by
About this trial
This is an interventional treatment trial for Stage II Peripheral Arterial Occlusive Disease focused on measuring Alprostadil, Prostaglandin E1, Prostavasin®, PAOD
Eligibility Criteria
Inclusion Criteria:
- Subjects with Peripheral Arterial Occlusive Disease (PAOD) of the lower extremity in Fontaine stage II
- Maximum walking distance on the treadmill (12 %, 3 km/h) between 30 and 150 m
- Stable Intermittent Claudication of at least 6 months standing with no acute shortening of walking distance over the past 3 months
- Stenoses or occlusions below the Femoral Bifurcation (above-knee or below-knee type) confirmed by duplex US or angiography
- Ankle/brachial index ≤ 0.90 with a decrease in systolic ankle pressure of ≥ 10 % after maximum loading (maximum walking distance on the treadmill at 3 km/h, 12 %)
- The patient is physically and mentally capable of participating in the trial
- Patient age > 40 years, male and female
- Patient is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent
- Patient is willing and able to comply with all trial requirements
Exclusion Criteria:
- Surgical or other interventional measures performed on the affected extremity and Prostaglandin treatment within the 6 months immediately prior to the trial
- Rest pain and Necroses
- Systolic ankle pressure less than 50 mmHg
- Change in maximum walking distance during the one-week Run-in Phase of more than ± 25 % of Baseline
- Successful physical walking training within the 6 months immediately prior to the trial
- Inflammatory vascular diseases
- Polyneuropathy in Diabetes Mellitus
- Diseases limiting walking distance (Arthrosis, inflammatory diseases of the joints, neurological disease, diseases of the Vertebral Column, cardiopulmonary diseases)
- History of Pulmonary Oedema
- Myocardial infarction within the past 6 months
- Pregnancy or nursing
- Known hypersensitivity to any components of the trial medication or comparative drug
- Renal insufficiency, compensated retention (creatinine > 2.0 mg/dL)
- Severe retinal Haemorrhage
- Massive Haemorrhage
- Known existing malignant diseases
- Vasoactive concomitant medication (e.g. Naftidrofuryl, Pentoxifylline, Buflomedil, Cilostazol), or other Prostaglandins
- Untreated or uncontrolled Hypertension (systolic blood pressure ≥ 180 mmHg, diastolic blood pressure ≥ 110 mmHg)
- Previous participation of the patient in the present trial
- Participation of the patient in a trial with the same objectives within the past 6 months, or is currently participating in another trial
- Illness of the patient due to alcohol or drug-abuse within the past 6 months
- Serious illness of the patient that the investigator considers to compromise his/her participation in the trial
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Alprostadil
Pentoxifylline
Arm Description
Alprostadil (Prostaglandin E1) intravenous and matching Placebo to Pentoxifylline oral
Pentoxifylline oral and matching Placebo to Alprostadil (Prostaglandin E1) intravenous
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Information
1. Study Identification
Unique Protocol Identification Number
NCT01263925
Brief Title
Prostaglandin E1 in Outpatients With Intermittent Claudication
Official Title
Intravenous Prostaglandin E1 Treatment in Outpatients With Intermittent Claudication
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage II Peripheral Arterial Occlusive Disease, Intermittent Claudication Fontaine Stage II PAOD
Keywords
Alprostadil, Prostaglandin E1, Prostavasin®, PAOD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
561 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alprostadil
Arm Type
Experimental
Arm Description
Alprostadil (Prostaglandin E1) intravenous and matching Placebo to Pentoxifylline oral
Arm Title
Pentoxifylline
Arm Type
Active Comparator
Arm Description
Pentoxifylline oral and matching Placebo to Alprostadil (Prostaglandin E1) intravenous
Intervention Type
Drug
Intervention Name(s)
Alprostadil (Prostaglandin E1)
Other Intervention Name(s)
Prostavasin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline
Other Intervention Name(s)
Trental®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo to Pentoxifylline oral
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo to Alprostadil (Prostaglandin E1) intravenous
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings at Baseline
Description
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.
Time Frame
From Baseline to the end of 4 weeks of Interval Treatment (Period 2)
Title
Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings at Baseline
Description
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.
Time Frame
From Baseline to the end of 6-months Follow-up (Period 3)
Title
Ratio of Pain-free Walking Distance After Period 1 in Comparison With the Findings at Baseline
Description
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.
Time Frame
From Baseline to the end of 4 weeks of Daily Treatment (Period 1)
Secondary Outcome Measure Information:
Title
Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings After Period 1
Description
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.
Time Frame
From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2)
Title
Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 1
Description
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.
Time Frame
From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3)
Title
Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 2
Description
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.
Time Frame
From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3)
Title
Ratio of Maximum Walking Distance After Period 1 in Comparison With the Findings at Baseline
Description
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.
Time Frame
From Baseline to the end of 4 weeks of Daily Treatment (Period 1)
Title
Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings at Baseline
Description
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.
Time Frame
From Baseline to the end of 4 weeks of Interval Treatment (Period 2)
Title
Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings After Period 1
Description
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.
Time Frame
From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2)
Title
Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings at Baseline
Description
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.
Time Frame
From Baseline to the end of 6-months Follow-up (Period 3)
Title
Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 1
Description
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.
Time Frame
From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3)
Title
Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 2
Description
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.
Time Frame
From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3)
Title
Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1
Description
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.
Time Frame
From Baseline to the end of 4 weeks of Daily Treatment (Period 1)
Title
Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3
Description
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.
Time Frame
From Baseline to the end of 6-months Follow-up (Period 3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with Peripheral Arterial Occlusive Disease (PAOD) of the lower extremity in Fontaine stage II
Maximum walking distance on the treadmill (12 %, 3 km/h) between 30 and 150 m
Stable Intermittent Claudication of at least 6 months standing with no acute shortening of walking distance over the past 3 months
Stenoses or occlusions below the Femoral Bifurcation (above-knee or below-knee type) confirmed by duplex US or angiography
Ankle/brachial index ≤ 0.90 with a decrease in systolic ankle pressure of ≥ 10 % after maximum loading (maximum walking distance on the treadmill at 3 km/h, 12 %)
The patient is physically and mentally capable of participating in the trial
Patient age > 40 years, male and female
Patient is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent
Patient is willing and able to comply with all trial requirements
Exclusion Criteria:
Surgical or other interventional measures performed on the affected extremity and Prostaglandin treatment within the 6 months immediately prior to the trial
Rest pain and Necroses
Systolic ankle pressure less than 50 mmHg
Change in maximum walking distance during the one-week Run-in Phase of more than ± 25 % of Baseline
Successful physical walking training within the 6 months immediately prior to the trial
Inflammatory vascular diseases
Polyneuropathy in Diabetes Mellitus
Diseases limiting walking distance (Arthrosis, inflammatory diseases of the joints, neurological disease, diseases of the Vertebral Column, cardiopulmonary diseases)
History of Pulmonary Oedema
Myocardial infarction within the past 6 months
Pregnancy or nursing
Known hypersensitivity to any components of the trial medication or comparative drug
Renal insufficiency, compensated retention (creatinine > 2.0 mg/dL)
Severe retinal Haemorrhage
Massive Haemorrhage
Known existing malignant diseases
Vasoactive concomitant medication (e.g. Naftidrofuryl, Pentoxifylline, Buflomedil, Cilostazol), or other Prostaglandins
Untreated or uncontrolled Hypertension (systolic blood pressure ≥ 180 mmHg, diastolic blood pressure ≥ 110 mmHg)
Previous participation of the patient in the present trial
Participation of the patient in a trial with the same objectives within the past 6 months, or is currently participating in another trial
Illness of the patient due to alcohol or drug-abuse within the past 6 months
Serious illness of the patient that the investigator considers to compromise his/her participation in the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
City
Aachen
Country
Germany
City
Bad Säckingen
Country
Germany
City
Berlin
Country
Germany
City
Bottrop
Country
Germany
City
Dortmund
Country
Germany
City
Dresden
Country
Germany
City
Düsseldorf
Country
Germany
City
Essen-Steele
Country
Germany
City
Essen
Country
Germany
City
Freiburg
Country
Germany
City
Gaggenau
Country
Germany
City
Görlitz
Country
Germany
City
Hamburg
Country
Germany
City
Hannover
Country
Germany
City
Hattingen
Country
Germany
City
Heidelberg
Country
Germany
City
Homburg
Country
Germany
City
Jena
Country
Germany
City
Karlsbad-Lang Ensteinbach
Country
Germany
City
Kassel
Country
Germany
City
Krefeld
Country
Germany
City
Köln
Country
Germany
City
Leipzig
Country
Germany
City
Lüneburg
Country
Germany
City
Mannheim-Lindenhof
Country
Germany
City
Mannheim
Country
Germany
City
Mönchengladbach
Country
Germany
City
München
Country
Germany
City
Neuss
Country
Germany
City
Nürnberg
Country
Germany
City
Osnabrück
Country
Germany
City
Papenburg
Country
Germany
City
Regensburg
Country
Germany
City
Seesen
Country
Germany
City
Warendorf
Country
Germany
City
Wuppertal
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Prostaglandin E1 in Outpatients With Intermittent Claudication
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