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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: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT01462565 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 16 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores was considered as better health status. C
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 |
What the finished NCT01462565 record still lists
NCT01462565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which current marketed FLOLAN (epoprostenol sodium) is the first listed.
NCT01462565 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01462565's enrollment target sits among peer trials
16 1869th of 2000 higher than 121 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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