NCT00942708

Brief Summary

This study will evaluate the safety, tolerability and efficacy of open-label fluoxetine for three months among patients with pulmonary arterial hypertension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
7.8 years until next milestone

Results Posted

Study results publicly available

May 22, 2019

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

1.7 years

First QC Date

July 19, 2009

Results QC Date

February 3, 2019

Last Update Submit

May 29, 2020

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary Arterial HypertensionPulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change in Pulmonary Vascular Resistance (PVR) at Three Months

    PVR will be measured by right heart catheterization at baseline and 3 months. Change in PVR will be determined by baseline value minus 3 month value.

    Change in PVR at 3 mos (Baseline - 3 months)

Secondary Outcomes (2)

  • Change Between Baseline and Three Month in the QIDS-SR Depression Scale

    Baseline - 3 months (median change)

  • Change in Six Minute Walk Distance at 3 Months

    3 months

Study Arms (1)

Fluoxetine

OTHER

Fluoxetine will be added starting at 20 mg and titrated as tolerated to 80 mg daily.

Drug: Fluoxetine

Interventions

FluoxetineDRUG

Total dose How to take: Week 1-2 20 mg daily Week 3-4 40 mg daily Week 5-6 40 mg BID Week 7-12 40mg BID

Also known as: Total dose How to take:, Week 1-2 20 mg daily, Week 3-4 40 mg daily, Week 5-6 40 mg BID, Week 7-12 40mg BID
Fluoxetine

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent prior to any study-mandated procedure
  • PAH of the following subtypes: idiopathic PAH WHO functional class II-III
  • Catheterization within one week showing mPAP \>=25, wedge or LV end diastolic pressure ≤15, and PVR \> 4 wood units, and baseline fick cardiac output results available
  • Age 16-75
  • Able to complete a six minute walk distance
  • Women of childbearing potential\*: negative serum pre-treatment pregnancy test + consistently and correctly uses a reliable method of contraception\*\* Oral approved PAH therapy for \>3 months with no change in dose for \> 1 month

You may not qualify if:

  • PAH with connective tissue disease, congenital heart disease, portal hypertension, glycogen storage disease, Gaucher's disease, hereditary hemorrhagic telangiectasia, hemoglobinopathy, myeloproliferative disorders.
  • Moderate to severe obstructive or restrictive lung disease: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \< 70% and FEV1 \< 60% of predicted value after bronchodilator administration. -or- total lung capacity (TLC) \< 60% of predicted.
  • Systemic systolic blood pressure \<100 mmHg Breastfeeding
  • Significant liver, renal or other medical disease preventing completion of the study procedures or with life expectancy \<12 months, or any other acute or chronic physical impairment (other than dyspnea), limiting the ability to comply with study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial HypertensionHypertension, Pulmonary

Interventions

FluoxetineBID protein, human

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Results Point of Contact

Title
Kelly Chin
Organization
UT Southwestern
kelly.chin@utsouthwestern.edu
214-645-5989

Study Officials

  • Kelly M Chin, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2009

First Posted

July 21, 2009

Study Start

September 1, 2009

Primary Completion

June 1, 2011

Study Completion

August 1, 2011

Last Updated

June 2, 2020

Results First Posted

May 22, 2019

Record last verified: 2020-05

Locations

US(1)