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

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

This study has been terminated.

Sponsored by:	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

MedlinePlus related topics:

Peripheral Arterial Disease Vascular Diseases

Drug Information available for:

U 62840

U.S. FDA Resources

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

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

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