Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension

Completed · Phase 2

Conditions studied: Pulmonary Arterial Hypertension

In brief

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

Key facts

Study ID

NCT00942708

Run by

University of Texas Southwestern Medical Center

People needed

6

Starts

2009-09-01

Expected to finish

2011-08-01

Last updated by the study team

2020-06-02

Who can join

Age: 16 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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