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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00060996
Recruitment Status : Terminated
First Posted : May 20, 2003
Last Update Posted : March 7, 2013
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

Brief Summary:
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 or disease Intervention/treatment Phase
Critical Limb Ischemia Peripheral Vascular Disease Foot Ulcers Rest Leg Pain Drug: Remodulin® (treprostinil sodium) Injection Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : February 2003
Primary Completion Date : September 2004
Study Completion Date : September 2004

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U.S. FDA Resources





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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT00060996     History of Changes
Other Study ID Numbers: REM 03:202
First Posted: May 20, 2003    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: March 2013

Keywords provided by United Therapeutics:
Critical Limb Ischemia
Peripheral Vascular Disease
UT-15
Remodulin
treprostinil

Additional relevant MeSH terms:
Ischemia
Foot Ulcer
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Treprostinil
Antihypertensive Agents