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

This study has been terminated.
Information provided by (Responsible Party):
United Therapeutics Identifier:
First received: May 19, 2003
Last updated: March 5, 2013
Last verified: March 2013
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 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by United Therapeutics:

Estimated Enrollment: 30
Study Start Date: February 2003
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Patients with Stage III or IV critical limb ischemia due to documented peripheral arterial disease with no planned interventional vascular procedures
  Contacts and Locations
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Please refer to this study by its identifier: NCT00060996

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
Study Director: Michael Wade, PhD United Therapeutics
  More Information

Responsible Party: United Therapeutics Identifier: NCT00060996     History of Changes
Other Study ID Numbers: REM 03:202
Study First Received: May 19, 2003
Last Updated: March 5, 2013

Keywords provided by United Therapeutics:
Critical Limb Ischemia
Peripheral Vascular Disease

Additional relevant MeSH terms:
Foot Ulcer
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Cardiovascular Diseases
Arterial Occlusive Diseases
Antihypertensive Agents processed this record on August 17, 2017