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

Tracking Information
First Received Date ^ICMJE	August 8, 2003
Last Updated Date	June 23, 2005
Start Date ^ICMJE	March 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00067041 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Effects of Remodulin in Patients With Critical Limb Ischemia Following a Vein Bypass Graft
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description
Study Phase	Phase II, Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Peripheral Vascular Disease
Intervention ^ICMJE	Drug: Remodulin (treprostinil sodium) Injection
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	30
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00067041
Responsible Party
Study ID Numbers ^ICMJE	REM03:203
Study Sponsor ^ICMJE	United Therapeutics
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	United Therapeutics
Verification Date	October 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP