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Effects of Remodulin in Patients With Critical Limb Ischemia Following a Vein Bypass Graft

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00067041
First Posted: August 13, 2003
Last Update Posted: March 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
United Therapeutics
August 8, 2003
August 13, 2003
March 7, 2013
March 2003
December 2003   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00067041 on ClinicalTrials.gov Archive Site
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Effects of Remodulin in Patients With Critical Limb Ischemia Following a Vein Bypass Graft
A Randomized Placebo-Controlled, 12-Week Multicenter Study of the Safety and Efficacy of Remodulin in Patients With Critical Limb Ischemia Following an Autogenous Vein Infrainguinal Bypass Graft
Approximately 30 patients will be enrolled in this 12-week study designed to assess the effect of continuous subcutaneous Remodulin therapy on the outcome of infrainguinal bypass grafts in patients with critical limb ischemia (CLI). Portions of the study will be conducted in the hospital and on an out-patient basis. The study will be conducted at multiple centers.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Peripheral Vascular Disease
Drug: Remodulin (treprostinil sodium) Injection
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
December 2003
December 2003   (Final data collection date for primary outcome measure)
  • Patients with critical limb ischemia and an appropriate reference lower-limb ischemic wound due to documented peripheral arterial disease who have had an autogenous vein infrainguinal bypass graft performed immediately prior to study initiation.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00067041
REM03:203
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United Therapeutics
United Therapeutics
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Not Provided
United Therapeutics
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP