Viewing Study NCT00060996



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Last Modification Date: 2024-10-26 @ 9:08 AM
Study NCT ID: NCT00060996
Status: TERMINATED
Last Update Posted: 2013-03-07
First Post: 2003-05-19

Brief Title: Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures
Sponsor: United Therapeutics
Organization: United Therapeutics

Study Overview

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
Status: TERMINATED
Status Verified Date: 2013-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None