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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 is a Phase 4 study that was terminated before completion, run by United Therapeutics. The registered enrollment target is 8 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00439946
The ClinicalTrials.gov registry entry for NCT00439946 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United Therapeutics, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which treprostinil is the first listed.
NCT00439946 reports 0 study locations.
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.
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