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Effects of Remodulin in Patients With Critical Limb Ischemia Following a Vein Bypass Graft
This study has been terminated.
First Received: August 8, 2003   Last Updated: June 23, 2005   History of Changes
Sponsor: United Therapeutics
Information provided by: United Therapeutics
ClinicalTrials.gov Identifier: NCT00067041
  Purpose

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.


Condition Intervention Phase
Peripheral Vascular Disease
Drug: Remodulin (treprostinil sodium) Injection
Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by United Therapeutics:

Estimated Enrollment: 30
Study Start Date: March 2003
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067041

Locations
United States, Illinois
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
United States, Massachusetts
University of Massachusetts Memorial Health Center
Worcester, Massachusetts, United States, 01655
United States, New York
Vascular Institute Albany Medical College
Albany, New York, United States, 12208
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
United Therapeutics
  More Information

No publications provided

Study ID Numbers: REM03:203
Study First Received: August 8, 2003
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00067041     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by United Therapeutics:
Critical Limb Ischemia
Autogenous Bypass Graft
CLI

Additional relevant MeSH terms:
Pathologic Processes
Peripheral Vascular Diseases
Therapeutic Uses
Treprostinil
Vascular Diseases
Cardiovascular Diseases
Cardiovascular Agents
Ischemia
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009