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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 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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00060996
Study type Interventional
Source United Therapeutics
Contact
Status Terminated
Phase Phase 3
Start date February 2003
Completion date September 2004
View Details
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