Clinical TrialID 6129
Prostaglandin E1 in Outpatients With Intermittent Claudication
NCT01263925
Stage II Peripheral Arterial Occlusive Disease|Intermittent Claudication Fontaine Stage II PAOD
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 6129
- Evidence Id
- 6129
- Core Evidence Id
- 6129
- Source Clinical Trial Id
- 6115
- Herb2 Clinical Trial Id
- HBCT006115
- Nct Id
- NCT01263925
- Title
- Prostaglandin E1 in Outpatients With Intermittent Claudication
- Status
- Completed
- Phase
- Phase 3
- Study Result
- Yes
- Study Condition
- Stage II Peripheral Arterial Occlusive Disease|Intermittent Claudication Fontaine Stage II PAOD
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: Alprostadil (Prostaglandin E1)|DRUG: Pentoxifylline|DRUG: Placebo to Pentoxifylline oral|DRUG: Placebo to Alprostadil (Prostaglandin E1) intravenous
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Double
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 561
- Outcome Measure
- 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)
- Sponsor Collaborator
- UCB Pharma
- Funded By
- INDUSTRY
- Location
- Aachen, Germany|Bad Säckingen, Germany|Berlin, Germany|Bottrop, Germany|Dortmund, Germany|Dresden, Germany|Düsseldorf, Germany|Essen-Steele, Germany|Essen, Germany|Freiburg, Germany|Gaggenau, Germany|Görlitz, Germany|Hamburg, Germany|Hannover, Germany|Hattingen, Germany|Heidelberg, Germany|Homburg, Germany|Jena, Germany|Karlsbad-Lang Ensteinbach, Germany|Kassel, Germany|Krefeld, Germany|Köln, Germany|Leipzig, Germany|Lüneburg, Germany|Mannheim-Lindenhof, Germany|Mannheim, Germany|Mönchengladbach, Germany|München, Germany|Neuss, Germany|Nürnberg, Germany|Osnabrück, Germany|Papenburg, Germany|Regensburg, Germany|Seesen, Germany|Warendorf, Germany|Wuppertal, Germany
- Other Id
- SP0580
- Start Date
- 2001-04
- Primary Completion Date
- 2011-04
- Completion Date
- 2011-04
- First Posted
- 2010-12-21
- Results First Posted
- 2012-06-29
- Last Update Posted
- 2014-10-27
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT01263925
- Title Cn
- Title En
- Prostaglandin E1 in Outpatients With Intermittent Claudication
- Bilingual Status
- semi_complete