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

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

This study has been terminated.

Study NCT00060996. Last updated on June 23, 2005. Information provided by United Therapeutics

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Critical Limb Ischemia
Peripheral Vascular Disease
Foot Ulcers
Rest Leg Pain

Intervention ^†

Drug: Remodulin® (treprostinil sodium) Injection

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Terminated

Enrollment ^†

Start Date ^†

February 2003

Completion Date

Eligibility Criteria ^†

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 ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00060996

Organization ID

REM 03:202

Secondary IDs ^††

Study Sponsor ^†

United Therapeutics

Collaborators ^††

Investigators ^†

Study Director:

Michael Wade, PhD

United Therapeutics

Information Provided By

United Therapeutics

Verification Date

October 2004

First Received Date ^†

May 19, 2003

Last Updated Date

June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.