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NCT00439946 · ClinicalTrials.gov registry record · Phase 4
Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH
A Phase 4 study, sponsored by United Therapeutics.
- Terminated
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
NCT00439946: Clinical Trial Phase 4 study, sponsored by United Therapeutics.
NCT00439946 is a Phase 4 study that was terminated before completion, run by United Therapeutics. The registered enrollment target is 8 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00439946, a Phase 4 study, was terminated before completion, sponsored by United Therapeutics.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
Study Summary
The purpose of this 8-week study is to compare the effects of switching from intravenous Flolan to intravenous Remodulin therapy. Remodulin (treprostinil sodium) is an approved therapy for pulmonary arterial hypertension (PAH). Unlike Flolan, Remodulin does not need to be mixed daily and is stable at room temperature, so there is no need for ice packs. In addition, Remodulin is changed every 48hrs, instead of every 12-24 (with ice packs) or every 8 hours (without ice packs) with Flolan. Flolan is given using a type of portable medication pump called the CADD Legacy infusion pump. In this study, Remodulin will be given using a smaller and lighter medication pump called the Crono Five infusion pump. This study will also assess the effect that changing to Remodulin will have on treatment satisfaction and patient quality of life.
Primary Outcome
The administration of the 6MWD test and specifications of the testing area were consistent with the American Thoracic Society guidelines and the usual practice of the investigative site \[American Thoracic Society (ATS) guidelines; 2002\].
Interventions
- DRUG treprostinil
- DEVICE Crono Five ambulatory pump
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2007-02 |
| Est. Completion | 2011-03 |
| Phase | Phase 4 |
Why NCT00439946 stopped before completion
NCT00439946 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which treprostinil is the first listed.
NCT00439946 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00439946 about?
NCT00439946 is a clinical study titled "Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH". The purpose of this 8-week study is to compare the effects of switching from intravenous Flolan to intravenous Remodulin therapy. Remodulin (treprostinil sodium) is an approved therapy for pulmonary arterial hypertension (PAH). Unlike Flolan, Remodulin does not need to be mixed daily and is stable a...
What is the current status of trial NCT00439946?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2007-02. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00439946?
The interventions under investigation include: treprostinil (DRUG), Crono Five ambulatory pump (DEVICE).
Who is sponsoring clinical trial NCT00439946?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00439946's enrollment target sits among peer trials
8 1972nd of 2000 higher than 20 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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