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NCT00060996 Clinical Trial

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

Critical Limb Ischemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00060996
Other study ID # REM 03:202
Secondary ID
Status Terminated
Phase Phase 3
First received May 19, 2003
Last updated March 5, 2013
Start date February 2003
Est. completion date September 2004

Study information
Verified date March 2013
Source United Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 30
Est. completion date September 2004
Est. primary completion date September 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Patients with Stage III or IV critical limb ischemia due to documented peripheral arterial disease with no planned interventional vascular procedures

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Remodulin® (treprostinil sodium) Injection

Locations
Country Name City State
United States South Carolina Heart Center Columbia South Carolina
United States The Methodist Hospital Houston Texas
United States Minneapolis Heart Institute Minneapolis Minnesota
United States Presbyterian Medical Center, Philadelphia Heart Institute Philadelphia Pennsylvania
United States Oregon Health Sciences University Portland Oregon
United States University of South Florida College of Medicine Tampa Florida
United States University of Massachusetts Memorial Health Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
United Therapeutics

Country where clinical trial is conducted

United States, 

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