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

This study has been terminated.

First Received: May 19, 2003 Last Updated: June 23, 2005 History of Changes

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 Arterial Disease Vascular Diseases

Drug Information available for: U 62840 Remodulin

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

No publications provided

Study ID Numbers:	REM 03:202
Study First Received:	May 19, 2003
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00060996 History of Changes
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
Vascular Diseases
Treprostinil
Pain

Ischemia
Cardiovascular Agents
Foot Diseases
Antihypertensive Agents
Skin Ulcer
Leg Ulcer

Additional relevant MeSH terms:

Foot Ulcer
Peripheral Vascular Diseases
Skin Diseases
Vascular Diseases
Treprostinil
Ischemia
Cardiovascular Agents
Foot Diseases

Antihypertensive Agents
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Skin Ulcer
Leg Ulcer

ClinicalTrials.gov processed this record on May 06, 2009