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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
History of Changes
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:

U.S. FDA Resources

Further study details as provided by United Therapeutics:

Estimated Enrollment: 30
Study Start Date: March 2003
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
  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

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT00067041     History of Changes
Other Study ID Numbers: REM03:203
Study First Received: August 8, 2003
Last Updated: March 5, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Ischemia
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Atherosclerosis
 Arteriosclerosis
Arterial Occlusive Diseases
Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013