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NCT00060996 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by United Therapeutics.

Terminated
Registry status
Phase 3
Development phase
30
Enrollment target

NCT00060996: Clinical Trial Phase 3 study, sponsored by United Therapeutics.

NCT00060996 is a Phase 3 study that was terminated before completion, run by United Therapeutics. The registered enrollment target is 30 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00060996, a Phase 3 study, was terminated before completion, sponsored by United Therapeutics.

TERMINATED
Registry status
Phase 3
Development phase
30 participants
Enrollment target

Study 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.

Interventions

  • DRUG Remodulin® (treprostinil sodium) Injection

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2003-02
Est. Completion 2004-09
Phase Phase 3
United Therapeutics

63 total trials

Why NCT00060996 stopped before completion

NCT00060996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which Remodulin® (treprostinil sodium) Injection is the first listed.

NCT00060996 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00060996 about?

NCT00060996 is a clinical study titled "Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures". 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...

What is the current status of trial NCT00060996?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2003-02. Estimated completion is 2004-09.

What interventions are being tested in trial NCT00060996?

The interventions under investigation include: Remodulin® (treprostinil sodium) Injection (DRUG).

Who is sponsoring clinical trial NCT00060996?

This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00060996's enrollment target sits among peer trials

30 1917th of 2000 higher than 68 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00060996, the US trial registry maintained by the National Library of Medicine. NCT00060996 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.