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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT00060996
First received: May 19, 2003
Last updated: March 5, 2013
Last verified: March 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT00060996     History of Changes
Other Study ID Numbers: REM 03:202
Study First Received: May 19, 2003
Last Updated: March 5, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 16, 2014