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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT00067041
First received: August 8, 2003
Last updated: March 5, 2013
Last verified: March 2013

August 8, 2003
March 5, 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00067041
REM03:203
Not Provided
United Therapeutics
United Therapeutics
Not Provided
Not Provided
United Therapeutics
March 2013

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