Ignite Creation Date:
2024-05-06 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03638908
Status:
COMPLETED
Last Update Posted:
2020-06-26
First Post:
2018-07-12
Brief Title:
Fluoxetine in Pulmonary Arterial Hypertension PAH Trial
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
A Phase 2 Open-label Clinical Trial of Fluoxetine a Selective Serotonin Reuptake Inhibitor in the Treatment of Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAH
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| STU 082013-045 | OTHER | UTSouthwestern Medical Center | None |