NCT00060996

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Limb Ischemia
• Peripheral Vascular Disease
• Foot Ulcers
• Rest Leg Pain

Interventions

Type	Name	Description
DRUG	Remodulin® (treprostinil sodium) Injection

Timeline

• Start date: 2003-02-01
• Primary completion: 2004-09-01
• Completion: 2004-09-01
• First posted: 2003-05-20
• Last updated: 2013-03-07

Locations

7 sites across 1 country: United States