Tamoxifen Therapy to Treat Pulmonary Arterial Hypertension
NCT03528902 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2024-12-05
Summary
The main purpose of this clinical trial is to examine the feasibility and effects of tamoxifen in subjects with pulmonary arterial hypertension (PAH). The study will evaluate how well the drug is tolerated, and its impact on functional condition and selected biomarkers. Changes in tricuspid annular plane systolic excursion (TAPSE) and other parameters determined by transthoracic echocardiography will be evaluated as well as changes in additional metrics such as six minute walk test distance, quality of life assessments, and hormone levels.
Conditions
- Hypertension
- Pulmonary Arterial Hypertension
- Familial Primary Pulmonary Hypertension
- Primary Pulmonary Hypertension
- Lung Diseases
- Tamoxifen
- Estrogen Receptor Antagonist
- Hormone Antagonists
- Estrogens
Interventions
- DRUG
-
Tamoxifen
Tamoxifen 20 mg po daily for 24 weeks.
- DRUG
-
Placebo Oral Tablet
Placebo
Sponsors & Collaborators
-
Vanderbilt University Medical Center
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-01
- Primary Completion
- 2023-06-14
- Completion
- 2023-06-14
- FDA Drug
- Yes
Countries
- United States
Study Locations
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