Effects of Remodulin in Patients With Critical Limb Ischemia Following a Vein Bypass Graft

Peripheral Vascular Disease Clinical Trial

Official title:

A Randomized Placebo-Controlled, 12-Week Multicenter Study of the Safety and Efficacy of Remodulin in Patients With Critical Limb Ischemia Following an Autogenous Vein Infrainguinal Bypass Graft

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00067041
• Other study ID #: REM03:203
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: August 8, 2003
• Last updated: March 5, 2013
• Start date: March 2003
• Est. completion date: December 2003

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

Approximately 30 patients will be enrolled in this 12-week study designed to assess the effect of continuous subcutaneous Remodulin therapy on the outcome of infrainguinal bypass grafts in patients with critical limb ischemia (CLI). Portions of the study will be conducted in the hospital and on an out-patient basis. The study will be conducted at multiple centers.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

• Patients with critical limb ischemia and an appropriate reference lower-limb ischemic wound due to documented peripheral arterial disease who have had an autogenous vein infrainguinal bypass graft performed immediately prior to study initiation.

Study Design

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Drug:
• Remodulin (treprostinil sodium) Injection

Locations

Country	Name	City	State
United States	Vascular Institute Albany Medical College	Albany	New York
United States	Oregon Health Sciences University	Portland	Oregon
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	University of Massachusetts Memorial Health Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
United Therapeutics

Country where clinical trial is conducted

United States,