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NCT01462565 · ClinicalTrials.gov registry record · Phase 4
Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH)
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT01462565 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 16 participants.
The verdict
NCT01462565, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this multicentre, open label, single-arm study in approximately 20 adult patients is to evaluate the Impact on lifestyle of a new thermo stable formulation of epoprostenol sodium in subjects with Pulmonary Arterial Hypertension (PAH).
Interventions
- DRUG current marketed FLOLAN (epoprostenol sodium)
- DRUG new thermo stable formulation of epoprostenol sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2011-11-01 |
| Est. Completion | 2012-11-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01462565
The ClinicalTrials.gov registry entry for NCT01462565 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which current marketed FLOLAN (epoprostenol sodium) is the first listed.
NCT01462565 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01462565 about?
NCT01462565 is a clinical study titled "Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH)". The purpose of this multicentre, open label, single-arm study in approximately 20 adult patients is to evaluate the Impact on lifestyle of a new thermo stable formulation of epoprostenol sodium in subjects with Pulmonary Arterial Hypertension (PAH).
What is the current status of trial NCT01462565?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2011-11-01. Estimated completion is 2012-11-08.
What interventions are being tested in trial NCT01462565?
The interventions under investigation include: current marketed FLOLAN (epoprostenol sodium) (DRUG), new thermo stable formulation of epoprostenol sodium (DRUG).
Who is sponsoring clinical trial NCT01462565?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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