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Terminated Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00060996

Public ClinicalTrials.gov record NCT00060996. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 2:26 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00060996
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
United Therapeutics
Industry
Enrollment
30 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2003 (Type not available)
Primary completion
Sep 2004 (Actual)
Completion
Sep 2004 (Actual)
Last update posted
Mar 7, 2013

2003 – 2004

United States locations

U.S. sites
7
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
University of South Florida College of Medicine Tampa Florida 33606 —
University of Massachusetts Memorial Health Worcester Massachusetts 01655 —
Minneapolis Heart Institute Minneapolis Minnesota 55407-1139 —
Oregon Health Sciences University Portland Oregon 97239 —
Presbyterian Medical Center, Philadelphia Heart Institute Philadelphia Pennsylvania 19104 —
South Carolina Heart Center Columbia South Carolina 29204 —
The Methodist Hospital Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00060996, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 7, 2013 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00060996 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →