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NCT03638908 · ClinicalTrials.gov registry record · Phase 2
Fluoxetine in Pulmonary Arterial Hypertension (PAH) Trial
A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT03638908 is a Phase 2 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 8 participants.
The verdict
NCT03638908, a Phase 2 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
This protocol describes an open-label phase 2 clinical trial of fluoxetine in PAH looking at change in pulmonary vascular resistance (PVR) as the primary endpoint. In this open-label clinical trial, 18 patients with pulmonary arterial hypertension will be given fluoxetine for 24 weeks. A Right Heart Catheterization will be performed at baseline and 24 weeks. Change in PVR will be the primary endpoint; other hemodynamic endpoints, quality of life, QIDS-SR depression scale, functional class and six-minute walk distance will also be evaluated. Primary Hypothesis: Fluoxetine treatment for 24 weeks will lead to significantly lower pulmonary vascular resistance in 18 patients with PAH in patients treated in an open-label clinical trial.
Interventions
- DRUG Fluoxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2013-11 |
| Est. Completion | 2018-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03638908
The ClinicalTrials.gov registry entry for NCT03638908 describes a study currently listed as completed, categorized as Phase 2. 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 University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fluoxetine is the first listed.
NCT03638908 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03638908 about?
NCT03638908 is a clinical study titled "Fluoxetine in Pulmonary Arterial Hypertension (PAH) Trial". This protocol describes an open-label phase 2 clinical trial of fluoxetine in PAH looking at change in pulmonary vascular resistance (PVR) as the primary endpoint. In this open-label clinical trial, 18 patients with pulmonary arterial hypertension will be given fluoxetine for 24 weeks. A Right Hear...
What is the current status of trial NCT03638908?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2013-11. Estimated completion is 2018-12.
What interventions are being tested in trial NCT03638908?
The interventions under investigation include: Fluoxetine (DRUG).
Who is sponsoring clinical trial NCT03638908?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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