Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures - Full Text View

Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures

This study has been terminated.

Sponsored by:	United Therapeutics
Information provided by:	United Therapeutics
ClinicalTrials.gov Identifier:	NCT00060996

Purpose

The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to determine the effect of Remodulin on wound healing and treadmill walk distance.

Condition	Intervention	Phase
Critical Limb Ischemia Peripheral Vascular Disease Foot Ulcers Rest Leg Pain	Drug: Remodulin® (treprostinil sodium) Injection	Phase III

MedlinePlus related topics:

Foot Health Peripheral Vascular Diseases Vascular Diseases

ChemIDplus related topics:

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 Continuous or Daily Administration of Remodulin® (Treprostinil Sodium) Injection in Patients With CLI With No Planned Revascularization Procedures

Further study details as provided by United Therapeutics:

Estimated Enrollment:	30
Study Start Date:	February 2003

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients with Stage III or IV critical limb ischemia due to documented peripheral arterial disease with no planned interventional vascular procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060996

Locations


United States, Florida
	University of South Florida College of Medicine
	Tampa, Florida, United States, 33606

United States, Massachusetts
	University of Massachusetts Memorial Health
	Worcester, Massachusetts, United States, 01655

United States, Minnesota
	Minneapolis Heart Institute
	Minneapolis, Minnesota, United States, 55407-1139

United States, Oregon
	Oregon Health Sciences University
	Portland, Oregon, United States, 97239

United States, Pennsylvania
	Presbyterian Medical Center, Philadelphia Heart Institute
	Philadelphia, Pennsylvania, United States, 19104

United States, South Carolina
	South Carolina Heart Center
	Columbia, South Carolina, United States, 29204

United States, Texas
	The Methodist Hospital
	Houston, Texas, United States, 77030

Sponsors and Collaborators

United Therapeutics

Investigators


Study Director:	Michael Wade, PhD	United Therapeutics

More Information

Study ID Numbers:	REM 03:202
First Received:	May 19, 2003
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00060996
Health Authority:	United States: Food and Drug Administration

Keywords provided by United Therapeutics:

Critical Limb Ischemia

Peripheral Vascular Disease

UT-15

Remodulin

treprostinil

Study placed in the following topic categories:

Foot Ulcer

Peripheral Vascular Diseases

Skin Diseases

Ulcer

Treprostinil

Vascular Diseases

Pain

Ischemia

Skin Ulcer

Foot Diseases

Leg Ulcer

Additional relevant MeSH terms:

Pathologic Processes

Therapeutic Uses

Cardiovascular Diseases

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2008