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

Tracking Information

First Received Date ^ICMJE

May 19, 2003

Last Updated Date

June 23, 2005

Start Date ^ICMJE

February 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00060996 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Critical Limb Ischemia
Peripheral Vascular Disease
Foot Ulcers
Rest Leg Pain

Intervention ^ICMJE

Drug: Remodulin® (treprostinil sodium) Injection

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Patients with Stage III or IV critical limb ischemia due to documented peripheral arterial disease with no planned interventional vascular procedures

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00060996

Responsible Party

Study ID Numbers ^ICMJE

REM 03:202

Study Sponsor ^ICMJE

United Therapeutics

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Michael Wade, PhD

United Therapeutics

Information Provided By

United Therapeutics

Verification Date

October 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP